Comparing three-dimensional endorectal ultrasound and magnification chromoendoscopy for early rectal neoplasia invasion depth assessment.

INTRODUCTION: Accurate assessment of invasion depth of early rectal neoplasms is essential for optimal therapy. We aimed to compare three-dimensional endorectal ultrasound (3D-ERUS) with magnification chromoendoscopy (MCE) regarding their accuracy in assessing parietal invasion depth (T). METHODS: Patients with middle and distal rectum neoplasms were prospectively included. Two providers blinded to each other's assessment performed 3D-ERUS and MCE, respectively. The T stage assessed through ERUS was compared to the MCE evaluation. The results were compared to the surgical specimen anatomopathological report. Sensitivity, specificity, accuracy, positive (PPV), and negative (NPV) predictive values were calculated for the T stage and for the final therapy (local excision or radical surgery). RESULTS: In 8 years, 70 patients were enrolled, and all underwent both exams. MCE and ERUS showed an accuracy of 94.3% and 85.7%, sensitivity of 83.7 and 93.3%, specificity of 96.4 and 83.6%, PPV of 86.7 and 60.9%, and NPV of 96.4 and 97.9%, respectively. Kappa for T stage assessed through ERUS was 0.64 and 0.83 for MCE. CONCLUSION: MCE and 3D-ERUS had good diagnostic performance, but the endoscopic method had higher accuracy. Both methods reliably assessed lesion extension, circumferential involvement, and distance from the anal verge.

Impact of a Routine Colorectal Endoscopic Submucosal Dissection in the Surgical Management of Nonmalignant Colorectal Lesions Treated in a Referral Cancer Center.

BACKGROUND: Recent data show an increasing number of abdominal surgeries being performed for the treatment of nonmalignant colorectal polyps in the West but in settings in which colorectal endoscopic submucosal dissection is not routinely performed. This study evaluated the number of nonmalignant colorectal lesions referred to surgical treatment in a tertiary cancer center that incorporated magnification chromoendoscopy and endoscopic submucosal dissection as part of the standard management of complex colorectal polyps. OBJECTIVE: The study aimed to estimate the number of patients with nonmalignant colorectal lesions referred to surgical resection at our institution after the standardization of routine endoscopic submucosal dissection and to describe outcomes for patients undergoing colorectal endoscopic submucosal dissection. DESIGN: Single-center retrospective study from a prospectively collected database of endoscopic submucosal dissections and colorectal surgeries performed between January 2016 and December 2019. SETTING: Reference cancer center. PATIENTS: Consecutive adult patients with complex nonmalignant colorectal polyps were included. INTERVENTIONS: Patients with nonmalignant colorectal polyps were treated by endoscopic submucosal dissection or surgery (elective colectomy, rectosigmoidectomy, low anterior resection, or proctocolectomy). MAIN OUTCOMES MEASURES: The primary outcome measure was the percentage of patients referred to colorectal surgery for nonmalignant lesions. RESULTS: In the study period, 1.1% of 825 colorectal surgeries were performed for nonmalignant lesions, and 97 complex polyps were endoscopically removed by endoscopic submucosal dissection. The en bloc, R0, and curative resection rates of endoscopic submucosal dissection were 91.7%, 83.5%, and 81.4%, respectively. The mean tumor size was 59 (SD 37.8) mm. Perforations during endoscopic submucosal dissection occurred in 3 cases, all treated with clipping. One patient presented with a delayed perforation 2 days after the endoscopic resection and underwent surgery. The mean follow-up period was 3 years, with no tumor recurrence in this cohort. LIMITATIONS: Single-center retrospective study. CONCLUSIONS: A workflow that includes assessment of the lesions with magnification chromoendoscopy and resection through endoscopic submucosal dissection can lead to a very low rate of abdominal surgery for nonmalignant colorectal lesions. See Video Abstract at http://links.lww.com/DCR/C123 . IMPACTO DE LA DISECCIN SUBMUCOSA ENDOSCPICA COLORRECTAL DE RUTINA EN EL MANEJO QUIRRGICO DE LESIONES COLORRECTALES NO MALIGNAS TRATADAS EN UN CENTRO ONCOLGICO DE REFERENCIA: ANTECEDENTES:Datos recientes muestran un número cada vez mayor de cirugías abdominales realizadas para el tratamiento de pólipos colorrectales no malignos en Occidente, pero no en los entornos donde la disección submucosa endoscópica colorrectal se realiza de forma rutinaria. El estudio evaluó el número de lesiones colorrectales no malignas referidas a tratamiento quirúrgico en un centro oncológico terciario, que incorporó cromoendoscopia de aumento y disección submucosa endoscópica como parte del manejo estándar de pólipos colorrectales complejos.OBJETIVO:Estimar el número de pacientes con lesiones colorrectales no malignas referidos para resección quirúrgica en nuestra institución, después de la estandarización de la disección submucosa endoscópica de rutina y describir los resultados para los pacientes sometidos a disección submucosa endoscópica colorrectal.DISEÑO:Estudio retrospectivo de un solo centro, a partir de una base de datos recolectada prospectivamente de disecciones submucosas endoscópicas y cirugías colorrectales realizadas entre enero de 2016 y diciembre de 2019.AJUSTE:Centro oncológico de referencia.PACIENTES:Pacientes adultos consecutivos con pólipos colorrectales no malignos complejos.INTERVENCIONES:Pacientes con pólipos colorrectales no malignos tratados mediante disección submucosa endoscópica o cirugía (colectomía electiva, rectosigmoidectomía, resección anterior baja o proctocolectomía).PRINCIPALES MEDIDAS DE RESULTADO:La medida de resultado primario fue el porcentaje de pacientes remitidos a cirugía colorrectal por lesiones no malignas.RESULTADOS:En el período, 1,1% de 825 cirugías colorrectales fueron realizadas por lesiones no malignas y 97 pólipos complejos fueron extirpados por. disección submucosa endoscópica. Las tasas de resección en bloque, R0 y curativa de disección submucosa endoscópica fueron 91,7%, 83,5% y 81,4%, respectivamente. El tamaño tumoral medio fue de 59 (DE 37,8) mm. Se produjeron perforaciones durante la disección submucosa endoscópica en 3 casos, todos tratados con clipaje. Un paciente presentó una perforación diferida 2 días después de la resección endoscópica y fue intervenido quirúrgicamente. El seguimiento medio fue de 3 años, sin recurrencia tumoral en esta cohorte.LIMITACIONES:Estudio retrospectivo de un solo centro.CONCLUSIONES:Un flujo de trabajo que incluye la evaluación de las lesiones con cromoendoscopia de aumento y resección a través de disección submucosa endoscópica, puede conducir a una tasa muy baja de cirugía abdominal para lesiones colorrectales no malignas. Consulte Video Resumen en http://links.lww.com/DCR/C123 . (Traducción-Dr. Fidel Ruiz Healy ).

Mucinous Degeneration on MRI After Neoadjuvant Therapy in Patients With Rectal Adenocarcinoma: Frequency and Association With Clinical Outcomes.

BACKGROUND. Patients with nonmucinous rectal adenocarcinoma may develop mucinous changes after neoadjuvant chemoradiotherapy, which are described as mucinous degeneration. The finding's significance in earlier studies has varied. OBJECTIVE. The purpose of this study was to assess the frequency of mucinous degeneration on MRI after neoadjuvant therapy for rectal adenocarcinoma and to compare outcomes among patients with nonmucinous tumor, mucinous tumor, and mucinous degeneration on MRI. METHODS. This retrospective study included 201 patients (83 women, 118 men; mean age, 61.8 ± 2.2 [SD] years) with rectal adenocarcinoma who underwent neoadjuvant chemoradiotherapy followed by total mesorectal excision from October 2011 to November 2015, underwent baseline and restaging rectal MRI examinations, and had at least 2 years of follow-up. Two radiologists independently evaluated MRI examinations for mucin content, which was defined as T2 hyperintensity in the tumor or tumor bed, and resolved differences by consensus. Patients were classified into three groups on the basis of mucin status: those with nonmucinous tumor (≤ 50% mucin content on baseline and restaging examinations), those with mucinous tumor (> 50% mucin content on baseline and restaging examinations), and those with mucinous degeneration (≤ 50% mucin content on baseline examination and > 50% content on restaging examination). The three groups were compared. RESULTS. Interreader agreement for mucin content, expressed as a kappa coefficient, was 0.893 on baseline MRI and 0.890 on restaging MRI. Of the 201 patients, 156 (77.6%) had nonmucinous tumor, 34 (16.9%) had mucinous tumor, and 11 (5.5%) had mucinous degeneration. Mucin status was not significantly associated with complete pathologic response (p = .41) or local or distant recurrence (both p > .05). The death rate during follow-up was not significantly different (p = .21) between patients with nonmucinous tumor (23.1%), those with mucinous tumor (29.4%), and those with mucinous degeneration (9.1%). In adjusted Cox regression analysis, with mucinous degeneration used as reference, the HR for the overall survival rate for the mucinous tumor group was 4.7 (95% CI, 0.6-38.3; p = .14), and that for the nonmucinous tumor group was 8.0 (95% CI, 0.9-59.9; p = .06). On histopathologic assessment, all 11 patients with mucinous degeneration showed acellular mucin, yet 10 of 11 patients showed viable tumor (i.e., in nonmucinous portions of the tumors). CONCLUSION. Mucinous degeneration on MRI is not significantly associated with pathologic complete response, recurrence, or survival. CLINICAL IMPACT. Mucinous degeneration on MRI is uncommon and should not be deemed an indicator of pathologic complete response.

Outcomes of Patients With Local Regrowth After Nonoperative Management of Rectal Cancer After Neoadjuvant Chemoradiotherapy.

BACKGROUND: Clinical complete responders after chemoradiation for rectal cancer are increasingly being managed by a watch-and-wait strategy. Nonetheless, a significant proportion will experience a local regrowth, and the long-term oncological outcomes of these patients is not totally known. OBJECTIVE: The purpose of this study was to analyze the outcomes of patients who submitted to a watch-and-wait strategy and developed a local regrowth, and to compare these results with sustained complete clinical responders. DESIGN: This was a retrospective study. SETTING: Single institution, tertiary cancer center involved in alternatives to organ preservation. PATIENTS: Patients with a biopsy-proven rectal adenocarcinoma (stage II/III or low lying cT2N0M0 at risk for an abdominoperineal resection) treated with chemoradiation who were found at restage to have a clinical complete response. INTERVENTIONS: Rectal cancer patients treated with chemoradiation who underwent a watch-and-wait strategy (without a full thickness local excision) and developed a local regrowth were compared to the remaining patients of the watch-and-wait strategy. MAIN OUTCOME MEASURES: Overall survival between groups, incidence of regrowth' and results of salvage surgery. RESULTS: There were 67 patients. Local regrowth occurred in 20 (29.9%) patients treated with a watch-and-wait strategy. Mean follow-up was 62.7 months. Regrowth occurred at mean 14.2 months after chemoradiation, half of them within the first 12 months. Patients presented with comparable initial staging, lateral pelvic lymph-node metastasis, and extramural venous invasion. The regrowth group had a statistically nonsignificant higher incidence of mesorectal fascia involvement (35.0% vs 13.3%, p = 0.089). All regrowths underwent salvage surgery, mostly (75%) a sphincter-sparing procedure. 5-year overall survival was 71.1% in patients with regrowth and 91.1% in patients with a sustained complete clinical response (p = 0.027). LIMITATIONS: This study was limited by its retrospective evaluation of patient selection for a watch-and-wait strategy and outcomes, as well as its small sample size. CONCLUSIONS: Local regrowth is a frequent event when following a watch-and-wait policy (29.9%); however, patients could undergo salvage surgical treatment with adequate pelvic control. In this series, overall survival showed a statistically significant difference from patients managed with a watch-and-wait strategy who experienced a local regrowth compared to those who did not. See Video Abstract at http://links.lww.com/DCR/B773.RESULTADOS DE LOS PACIENTES CON REBROTE LOCAL, DESPUÉS DEL MANEJO NO QUIRÚRGICO DEL CÁNCER DE RECTO, DESPUÉS DE LA QUIMIORRADIOTERAPIA NEOADYUVANTEANTECEDENTES:Los respondedores clínicos completos, después de la quimiorradiación para el cáncer de recto, se tratan cada vez más mediante una estrategia de observación y espera. No obstante, una proporción significativa experimentará un rebrote local y los resultados oncológicos a largo plazo de estos pacientes, no se conocen por completo.OBJETIVO:El propósito de este estudio, fue analizar los resultados de los pacientes sometidos a una estrategia de observación y espera, que desarrollaron un rebrote local, y comparar estos resultados con respondedores clínicos completos sostenidos.DISEÑO:Este fue un estudio retrospectivo.ENTORNO CLINICO.Institución única, centro oncológico terciario involucrado en alternativas a la preservación de órganos.PACIENTES:Pacientes con un adenocarcinoma de recto comprobado por biopsia (estadio II / III o posición baja cT2N0M0, en riesgo de resección abdominoperineal), tratados con quimiorradiación, y que durante un reestadiaje, presentaron una respuesta clínica completa.INTERVENCIONES:Los pacientes con cáncer de recto tratados con quimiorradiación, sometidos a una estrategia de observación y espera (sin una escisión local de espesor total) y que desarrollaron un rebrote local, se compararon con los pacientes restantes de la estrategia de observación y espera.PRINCIPALES MEDIDAS DE VALORACION:Supervivencia global entre los grupos, incidencia de rebrote y resultados de la cirugía de rescate.RESULTADOS:Fueron 67 pacientes. El rebrote local ocurrió en 20 (29,9%) pacientes tratados con una estrategia de observación y espera. El seguimiento medio fue de 62,7 meses. El rebrote se produjo a la media de 14,2 meses después de la quimiorradiación, la mitad de ellos dentro de los primeros 12 meses. Los pacientes se presentaron con una estadificación inicial comparable, metástasis en los ganglios linfáticos pélvicos laterales e invasión venosa extramural. El grupo de rebrote tuvo una mayor incidencia estadísticamente no significativa de afectación de la fascia mesorrectal (35,0 vs 13,3%, p = 0,089). Todos los rebrotes se sometieron a cirugía de rescate, en su mayoría (75%) con procedimiento de preservación del esfínter. La supervivencia global a 5 años fue del 71,1% en pacientes con rebrote y del 91,1% en pacientes con una respuesta clínica completa sostenida (p = 0,027).LIMITACIONES:Evaluación retrospectiva de la selección de pacientes para una estrategia y resultados de observar y esperar, tamaño de muestra pequeño.CONCLUSIONES:El rebrote local es un evento frecuente después de la política de observación y espera (29,9%), sin embargo los pacientes podrían someterse a un tratamiento quirúrgico de rescate con un adecuado control pélvico. En esta serie, la supervivencia global mostró una diferencia estadísticamente significativa de los pacientes manejados con una estrategia de observación y espera que experimentaron un rebrote local, en comparación con los que no lo hicieron. Consulte Video Resumen en http://links.lww.com/DCR/B773. (Traducción-Dr. Fidel Ruiz Healy).

Pretreatment colostomy in patients with anal squamous cell carcinoma: Risk factors for a permanent stoma.

BACKGROUND: The current standard of care for anal squamous cell carcinoma (SCC) is concurrent chemoradiation (CRT), which enables tumor eradication while preserving the anal sphincter. Patients with locally advanced tumors, however, may experience complications that preclude treatment before stoma creation. OBJECTIVE: To evaluate the reversal rate of pretreatment stomas and the risk factors associated with nonreversal. METHODS: This single-institution retrospective cohort study using a prospective database included patients diagnosed with anal SCC from January 2008 to December 2020 who required a stoma before curative CRT. RESULTS: In total, 651 patients were identified; 65 required a stoma before chemoradiation due to obstruction (43.1%), rectovaginal fistula (20%), and perianal sepsis (36.9%). The stoma was reversed in nine patients after a mean follow-up of 35.8 months. Risk factors associated with a permanent stoma were perianal sepsis (p = 0.010), interruptions during radiotherapy for more than 7 days (p = 0.010), male sex (p = 0.013), poor performance status (Eastern Cooperative Oncology Group [ECOG] ≥ 2) (p = 0.023), large tumors (p = 0.045), and cisplatin-based chemotherapy (p = 0.047). CONCLUSIONS: Pretreatment stomas are unlikely to be reversed, and risk factors for a permanent stoma are perianal sepsis, interruptions during radiotherapy for more than 7 days, male sex, poor performance status (ECOG ≥ 2), large tumors, and cisplatin-based chemotherapy.

Long-term outcomes of endoscopic submucosal dissection and transanal endoscopic microsurgery for the treatment of rectal tumors.

BACKGROUND AND AIM: Endoscopic submucosal dissection and transanal endoscopic microsurgery are good options for the treatment of rectal adenomas and early rectal carcinomas, but whether long-term outcomes of these procedures are comparable is not known. The aim of this study was to address this question. METHODS: A retrospective single-center study evaluating 98 consecutive procedures between June 2008 and December 2017 was performed in a tertiary cancer center. Consecutive patients who had undergone either endoscopic submucosal resection or transanal endoscopic microsurgery for rectal adenomas and early rectal carcinomas were evaluated, and long-term recurrence and complication rates were compared. RESULTS: Both groups were similar regarding sex, age, preoperative surgical risk, and en bloc resection rate (95.7% in the endoscopic and 100% in the surgical group, P = 0.81). Mean follow-up period was 37.6 months. Lesions resected endoscopically were significantly larger (68.5 mm) than those resected by transanal resection (44.5 mm), P = 0.003. Curative resections occurred in 97.2% of endoscopic resections and 85.2% of the surgical ones (P = 0.04). Comparing resections that fulfilled histologic curative criteria, there were no recurrences in the endoscopic group (out of 69 cases) and two recurrences in the transanal group (8.3% of 24 cases), P = 0.06. Late complications occurred in 12.7% of endoscopic procedures and 25.9% of surgical procedures (P = 0.13). CONCLUSIONS: In our experience, endoscopic submucosal resection seems to have advantages over transanal endoscopic microsurgery, with similar en bloc resection rate and lower rate of late complications and recurrences. Multicenter randomized controlled trials are needed to support our findings.

Role of Magnification Chromoendoscopy in the Management of Colorectal Neoplastic Lesions Suspicious for Submucosal Invasion.

BACKGROUND: Correctly predicting the depth of tumor invasion in the colorectal wall is crucial for successful endoscopic resection of superficial colorectal neoplasms. OBJECTIVE: The aim of this study was to assess the accuracy of magnifying chromoendoscopy in a Western medical center to predict the depth of invasion by the pit pattern classification in patients with colorectal neoplasms with a high risk of submucosal invasion. DESIGN: This single-center retrospective study, from a prospectively collected database, was conducted between April 2009 and June 2015. SETTINGS: The study was conducted at a single academic center. PATIENTS: Consecutive patients with colorectal neoplasms with high risk of submucosal invasion were included. These tumors were defined by large (≥20 mm) sessile polyps (nonpedunculated), laterally spreading tumors, or depressed lesions of any size. INTERVENTIONS: Patients underwent magnifying chromoendoscopy and were classified according to the Kudo pit pattern. The therapeutic decision, endoscopic or surgery, was defined by the magnification assessment. MAIN OUTCOME MEASURES: Sensitivity, specificity, and positive and negative predictive values of magnifying chromoendoscopy for assessment of these lesions were determined. RESULTS: A total of 123 lesions were included, with a mean size of 54.0 ± 37.1 mm. Preoperative magnifying chromoendoscopy with pit pattern classification had 73.3% sensitivity, 100% specificity, 100% positive predictive value, 96.4% negative predictive value, and 96.7% accuracy to predict depth of invasion and consequently to guide the appropriate treatment. Thirty-three rectal lesions were also examined by MRI, and 31 were diagnosed as T2 lesions. Twenty two (70.1%) of these lesions were diagnosed as noninvasive by magnifying colonoscopy, were treated by endoscopic resection, and met the curative criteria. LIMITATIONS: This was a single-center retrospective study with a single expert endoscopist experience. CONCLUSIONS: Magnifying chromoendoscopy is highly accurate for assessing colorectal neoplasms suspicious for submucosal invasion and can help to select the most appropriate treatment. See Video Abstract at http://links.lww.com/DCR/A920.

T≤2N0 TRG1-2 in Post-Chemoradiation Therapy MRI: What can it Predict?

BACKGROUND: Total mesorectal excision is the standard radical operation after neoadjuvant chemoradiotherapy for patients with middle/low locally advanced rectal cancer. However, it carries significant rates of morbidity, sexual/urinary dysfunction, fecal impairment and permanent stoma. The ability to identify patients with a complete or nearly-complete response could help steer patients to less-invasive surgery or a watch-and-wait strategy. OBJECTIVE: To assess the ability to predict good responders and a favorable prognosis among rectal cancer patients by post-chemoradiation therapy MRI. PATIENTS: Consecutive patients stage T3-4N0M0 or T(any)N+M0 located within 10cm from the anal verge were enrolled. Patients were staged and re-staged 8.8 weeks after the completion of chemoradiation by digital exam, colonoscopy, pelvic-MRI, and thorax and abdominal CT scans. All patients underwent total mesorectal excision with curative intent. RESULTS: Of the total 309 patients, 275 were eligible, and 199 (72.4%) of these were stage III. Restaging-MRI identified 59 (21.4%) T=2N0/TRG1-2. Specimen pathologic evaluation revealed 43 (15.6%) patients with a complete pathologic response. Estimates of the accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of MRIyT=2N0/TRG1-2 for the identification of ypT0N0 were 79.7%, 84.5%, 53.5%, 39%, and 90.7%, respectively. Estimates for the identification of ypN0 were 48.4%, 27.8%, 92%, 88.1%, and 48.4%, respectively. In a multivariate analysis, the only pre-CRT/MRI variables that were associated with an increased risk of lymph node involvement at the specimen were N+ (OR=2.22) and extramural vascular invasion (OR=2.28). MRI yT=2N0/TRG1-2 patients showed improved estimated 5-year disease-free survival, but no difference in estimated 5-year survival. CONCLUSION: Although MRIyT=2N0/TRG1-2 cannot predict all cases of a complete pathologic response, it can effectively predict a low rate of lymph node involvement and a better prognosis in patients who undergo total mesorectal excision.

Efficacy of 3-Dimensional Endorectal Ultrasound for Staging Early Extraperitoneal Rectal Neoplasms.

BACKGROUND: Adequate oncologic staging of rectal neoplasia is important for treatment and prognostic evaluation of the disease. Diagnostic methods such as endorectal ultrasound can assess rectal wall invasion and lymph node involvement. OBJECTIVE: The purpose of this study was to correlate findings of 3-dimensional endorectal ultrasound and pathologic diagnosis of extraperitoneal rectal tumors with regard to depth of rectal wall invasion, lymph node involvement, percentage of rectal circumference involvement, and tumor extension. DESIGN: Consecutive patients with extraperitoneal rectal tumors were prospectively assessed by 3-dimensional endorectal ultrasound blind to other staging methods and pathologic diagnosis. PATIENTS: Patients who underwent endorectal ultrasound followed by surgery were included in the study. SETTINGS: The study was conducted at a single academic institution. MAIN OUTCOME MEASURES: Sensitivity, specificity, positive and negative predictive values, area under curve, and κ coefficient between 3-dimensional endorectal ultrasound and pathologic diagnosis were determined. Intraclass correlation coefficient was calculated for tumor extension and percentage of rectal wall involvement. RESULTS: Forty-four patients (27 women; mean age = 63.5 years) were evaluated between September 2010 and June 2014. Most lesions were malignant (72.7%). For depth of submucosal invasion, 3-dimensional endorectal ultrasound showed sensitivity of 77.3%, specificity of 86.4%, positive predictive value of 85.0%, a negative predictive value of 79.2%, and an area under curve of 0.82. The weighted κ coefficient for depth of rectal wall invasion staging was 0.67, and there was no agreement between 3-dimensional endorectal ultrasound and pathologic diagnosis for lymph node involvement (κ = -0.164). Intraclass correlation coefficient for lesion extension and percentage of rectal circumference involvement were 0.45 and 0.66. A better correlation between 3-dimensional endorectal ultrasound and pathologic diagnosis was observed in tumors <5 cm and with <50% of rectal wall involvement. LIMITATIONS: The relatively small sample size of patients with early rectal lesions referred directly for surgery could represent a potential selection bias. CONCLUSIONS: Three-dimensional endorectal ultrasound was effective for determining rectal wall invasion and lesion extension in tumors <5 cm and with <50% of rectal wall invasion but was limited for detecting lymph node involvement in early rectal lesions.

Outcomes of Immediate Internal Pudendal Artery Perforator Flap Reconstruction for Irradiated Abdominoperineal Resection Defects.

BACKGROUND: There are many previous reports for using the internal pudendal artery perforator flap in vulvovaginal reconstruction; however, reports of this flap for perineal reconstruction after abdominoperineal excision of the rectum are scarce. OBJECTIVE: The purpose of this study was to evaluate the outcomes of immediate internal pudendal artery perforator flap reconstruction for irradiated abdominoperineal resection defects. DESIGN: This was a prospective case series. SETTINGS: This flap could represent a step forward over other perineal flap approaches or primary closure. PATIENTS: A total of 73 consecutive patients with anorectal tumors were included. INTERVENTIONS: The study included immediate perineal reconstruction using 122 internal pudendal artery perforator flaps after abdominoperineal excision of the rectum. MAIN OUTCOME MEASURES: Dimensions of the perineal defect (in centimeters squared), hospital stay (days), healing time (days), and postoperative complications (Clavien-Dindo grades) were measured. RESULTS: The means of the perineal defect, hospital stay, and healing time were 51.62 cm, 15.94 days, and 38.52 days. The higher the patient BMI, the longer healing time (p = 0.02); Clavien-Dindo complications grades III to IV were greater in patients with perineal defect ≥60 cm (p = 0.03; OR = 10.56); postoperative complications were higher both in patients with anal squamous cell carcinoma (p = 0.005; OR = 6.09) and in patients with comorbidities (p = 0.04; OR = 2.78); hospital stay (p= 0.001) and healing time (p < 0.001) were higher in patients who had postoperative complications. The complete perineal wound healing at 12 weeks was achieved by 95% of patients, and our 30-day mortality rate was 4%. LIMITATIONS: As a nonrandomized study, our results have to be interpreted with caution. CONCLUSIONS: Multiple previously described advantages associated with internal pudendal artery perforator flap were also observed here, reinforcing the idea that it is reliable, versatile, and a useful option for perineal reconstruction after abdominoperineal excision of the rectum. Therefore, we propose that this flap could be considered as the first choice for perineal reconstruction in selected patients with moderate and some large defects after abdominoperineal excision of the rectum. See Video Abstract at http://links.lww.com/DCR/A367.

Endoscopic colostomy with percutaneous colopexy: an animal feasibility study.

BACKGROUND: Indications for colostomy in colorectal diseases are obstruction of the large bowel, such as in cancer, diverticular disease in the acute phase, post-radiotherapy enteritis, complex perirectal fistulas, anorectal trauma and severe anal incontinence. Some critically ill patients cannot tolerate an exploratory laparotomy, and laparoscopic assisted colostomy also requires general anesthesia. OBJECTIVE: To evaluate the feasibility, safety and efficacy of performing colostomy assisted by colonoscopy and percutaneous colopexy. MATERIALS AND METHODS: Five pigs underwent endoscopic assisted colostomy with percutaneous colopexy. Animals were evaluated in post-operative days 1, 2, 5 and 7 for feeding acceptance and colostomy characteristics. On day 7 full colonoscopy was performed on animals followed by exploratory laparotomy. RESULTS: Average procedure time was 27 minutes (21-54 min). Postoperative mobility and feeding of animals were immediate after anesthesia recovery. Position of the colostomy, edges color, appearance of periostomal area, as well as its function was satisfactory in four animals. Retraction of colostomy was present in one pig. The colonoscopy and laparotomy control on the seventh day were considered as normal. A bladder perforation that was successfully repaired through the colostomy incision occurred in one pig. The main limitation of this study is its experimental nature. CONCLUSION: Endoscopic assisted colostomy with percutaneous colopexy proves to be a safe and effective method with low morbidity for performing colostomy in experimental animals, with possible clinical application in humans.

Pathologic Complete Response in Rectal Cancer: Can We Detect It? Lessons Learned From a Proposed Randomized Trial of Watch-and-Wait Treatment of Rectal Cancer.

BACKGROUND: Chemoradiotherapy has the potential to downsize and downstage tumors before surgery, decrease locoregional recurrence, and induce a complete sterilization of tumor cells for middle and low locally advanced rectal cancer. A watch-and-wait tactic has been proposed for patients with clinical complete response. OBJECTIVE: The purpose of this study was to verify our ability to identify complete clinical response in patients with rectal cancer based on clinical and radiologic criteria. DESIGN: This was a prospective study. SETTINGS: The study was conducted at a single institution, in the setting of a watch-and-wait randomized trial. PATIENTS: Consecutive patients with stage T3 to T4N0M0 or T(any)N+M0 cancer located within 10 cm from anal verge or T2N0 within 7 cm from anal verge were included in the study. Patients were staged and restaged 8 weeks after completion of chemoradiation (5-fluorouracil, 5040 cGy) by digital examination, colonoscopy, pelvic MRI, and thorax and abdominal CT scans. MAIN OUTCOME MEASURES: Clinical and radiologic judgments of tumor response were compared with pathologic response of patients treated by total mesorectal excision or clinical follow-up of patients selected for nonoperative treatment. RESULTS: A total of 118 patients were treated. Six patients were considered clinic complete responders (2 randomly assigned for surgery (1 ypT0N0 and 1 ypT2N0) and 4 patients randomly assigned for observation (3 sustained clinic complete response and 1 had tumor regrowth)). The 112 clinic incomplete responders underwent total mesorectal excision, and 18 revealed pathologic complete response. These 18 patients were not considered complete responders at restaging because they presented at least 1 of the following conditions: mucosal ulceration and/or deformity and/or substenosis of rectal lumen at digital rectal examination and colonoscopy (n = 16), ymrT1 to T4 (n = 16), ymrN+ (n = 2), involvement of circumferential resection margin on MRI (n = 3), extramural vascular invasion on MRI (n = 4), MRI tumor response grade 2 to 4 (n = 15), and pelvic side wall lymph node involvement on MRI (n = 1). Sensitivity for identification of ypT0N0 or sustained clinic complete response was 18.2%. LIMITATIONS: This study has a short follow-up and small sample size. Radiologists who reviewed the restaging examination were not blinded to the pretreatment stage. Only 1 radiologist read the images of each patient. CONCLUSIONS: Evaluation of clinic complete response according to current adopted criteria has low sensitivity because pathologic complete response more frequently presented as clinic incomplete response (see Video, Supplemental Digital Content 1, http://links.lww.com/DCR/A221).

Postoperative complications in the treatment of rectal neoplasia by transanal endoscopic microsurgery: a prospective study of risk factors and time course.

PURPOSE: Transanal endoscopic microsurgery (TEM) is a safe and efficient minimally invasive treatment for rectal benign and early malignant neoplasia, but postoperative complications may be severe. We aimed to evaluate the risk factors related to the incidence, severity, and time course of postoperative complications of TEM. METHODS: This is a prospective study of postoperative complications in 53 patients (>18 years old) with benign or early rectal neoplasia who underwent TEM with curative intention or, for higher stages, palliation. Outcome measures included age, sex, American Society of Anesthesiologists score, neoadjuvant chemoradiotherapy, lesion height and size, pathologic margins, tumor histology, and suture type. RESULTS: Overall morbidity was 50 %. Temporary fecal incontinence was the most frequent complication (17.3 %). Complication rates of Clavien-Dindo grades I and II were 21.1 % and those of grades III and IV 3.8 %. Of patients with complications, more had lesions under the first rectal valve than over the first valve (61.54 % vs 38.46 %, p = 0.04). Patients submitted to chemoradiotherapy had a 24-fold greater chance of presenting grade II complications (p = 0.002). When the surgical defect was treated using the TEM device to perform the suture, the chance of having grade III complications was reduced 16-fold (p = 0.04). Fifty-three percent of complications occurred in the first 10 days and 95 % within 20 days. CONCLUSIONS: Postoperative complications after transanal endoscopic microsurgery for the treatment of rectal neoplasia are frequent, acceptable, and usually controllable with pharmacologic treatment. Over time the nature of complications is continuous, centered on the first 20 days after surgery.

Endoscopic submucosal dissection versus transanal endoscopic microsurgery for the treatment of early rectal cancer.

BACKGROUND: Endoscopic submucosal dissection (ESD) and transanal endoscopic microsurgery (TEM) are minimally invasive procedures that can be used to treat early rectal cancer. OBJECTIVE: The aim of this study was to compare clinical efficacy between ESD and TEM for the treatment of early rectal cancer. METHODS: Between July 2008 and August 2011, 24 patients with early rectal cancers were treated by ESD (11) or TEM (13) at the Cancer Institute of São Paulo University Medical School (São Paulo, Brazil). Data were analyzed retrospectively according to database and pathological reports, with respect to en bloc resection rate, local recurrence, complications, histological diagnosis, procedure time and length of hospital stay. RESULTS: En bloc resection rates with free margins were achieved in 81.8 % of patients in the ESD group and 84.6 % of patients in the TEM group (p = 0.40). Mean tumor size was 64.6 ± 57.9 mm in the ESD group and 43.9 ± 30.7 mm in the TEM group (p = 0.13). Two patients in the TEM group and one patient in the ESD group had a local recurrence. The mean procedure time was 133 ± 94.8 min in the ESD group and 150 ± 66.3 min in the TEM group (p = 0.69). Mean hospital stay was 3.8 ± 3.3 days in the ESD group and 4.08 ± 1.7 days in the TEM group (p = 0.81). LIMITATIONS: This was a non-randomized clinical trial with a small sample size and selection bias in treatment options. CONCLUSION: ESD and TEM are both safe and effective for the treatment of early rectal cancer.

LAPAROSCOPIC RIGHT AND LEFT COLECTOMY: WHICH PROVIDES BETTER POSTOPERATIVE RESULTS FOR ONCOLOGY PATIENTS?

BACKGROUND: The laparoscopic approach considerably reduced the morbidity of colorectal surgery when compared to the open approach. Among its benefits, we can highlight less intraoperative bleeding, early oral intake, lower rates of surgical site infection, incisional hernia, and postoperative pain, and earlier hospital discharge. AIMS: To compare the perioperative morbidity of right versus left colectomy for cancer and the quality of laparoscopic oncologic resection. METHODS: Retrospective analysis of patients submitted to laparoscopic right and left colctomy between 2006 and 2016. Postoperative complications were classified using the Clavien-Dindo scale, 30 days after surgery. RESULTS: A total of 293 patients were analyzed, 97 right colectomies (33.1%) and 196 left colectomies (66.9%). The averageage was 62.8 years. The groups were comparable in terms of age, comorbidities, body mass index, and the American Society of Anesthesiology (ASA) classification. Preoperative transfusion was higher in the right colectomy group (5.1% versus 0.4%, p=0.004, p<0.05). Overall, 233 patients (79.5%) had no complications. Complications found were grade I and II in 62 patients (21.1%) and grade III to V in 37 (12.6%). Twenty-three patients (7.8%) underwent reoperation. The comparison between left and right colectomy was not statistically different for operative time, conversion, reoperation, severe postoperative complications, and length of stay. The anastomotic leak rate was comparable in both groups(5.6% versus 2.1%, p=0.232, p>0.05). The oncological results were similar in both surgeries. In multiple logistic regression, ASA statistically influenced the worst results (≥ III; p=0.029, p<0.05). CONCLUSIONS: The surgical and oncological results of laparoscopic right and left colectomies are similar, making this the preferred approach for both procedures.

MRI-based radiomic score increased mrTRG accuracy in predicting rectal cancer response to neoadjuvant therapy.

PURPOSE: To develop a magnetic resonance imaging (MRI)-based radiomics score, i.e., "rad-score," and to investigate the performance of rad-score alone and combined with mrTRG in predicting pathologic complete response (pCR) in patients with locally advanced rectal cancer following neoadjuvant chemoradiation therapy. METHODS: This retrospective study included consecutive patients with LARC who underwent neoadjuvant chemoradiotherapy followed by surgery from between July 2011 to November 2015. Volumes of interest of the entire tumor on baseline rectal MRI and of the tumor bed on restaging rectal MRI were manually segmented on T2-weighted images. The radiologist also provided the ymrTRG score on the restaging MRI. Radiomic score (rad-score) was calculated and optimal cut-off points for both mrTRG and rad-score to predict pCR were selected using Youden's J statistic. RESULTS: Of 180 patients (mean age = 63 years; 60% men), 33/180 (18%) achieved pCR. High rad-score (> - 1.49) yielded an area under the curve (AUC) of 0.758, comparable to ymrTRG 1-2 which yielded an AUC of 0.759. The combination of high rad-score and ymrTRG 1-2 yielded a significantly higher AUC of 0.836 compared with ymrTRG 1-2 and high rad-score alone (p < 0.001). A logistic regression model incorporating both high rad-score and mrTRG 1-2 was built to calculate adjusted odds ratios for pCR, which was 4.85 (p < 0.001). CONCLUSION: Our study demonstrates that a rectal restaging MRI-based rad-score had comparable diagnostic performance to ymrTRG. Moreover, the combined rad-score and ymrTRG model yielded a significant better diagnostic performance for predicting pCR.

The Role of Probe-Based Confocal Laser Endomicroscopy (pCLE) in the Diagnosis of Sustained Clinical Complete Response Under Watch-and-Wait Strategy After Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Adenocarcinoma: a Score Validation.

BACKGROUND: Watch-and-wait strategy has been increasingly accepted for patients with clinical complete response (cCR) after multimodal treatment for locally advanced rectal adenocarcinoma. Close follow-up is essential to the early detection of local regrowth. It was previously demonstrated that probe-based confocal laser endomicroscopy (pCLE) scoring using the combination of epithelial and vascular features might improve the diagnostic accuracy of cCR. AIM: To validate the pCLE scoring system in the assessment of patients with cCR after neoadjuvant chemoradiotherapy (nCRxt) for advanced rectal adenocarcinoma. METHODS: Digital rectal examination, pelvic magnetic resonance imaging (MRI), and pCLE were performed in 43 patients with cCR, who presented either a scar (N = 33; 76.7%) or a small ulcer with no signs of tumor, and/or biopsy negative for malignancy (N = 10; 23.3%). RESULTS: Twenty-five (58.1%) patients were men, and the mean age was 58.4 years. During the follow-up, 12/43 (27.9%) patients presented local regrowth and underwent salvage surgery. There was an association between pCLE diagnostic scoring and final histological report (for patients who underwent surgical resection) or final diagnosis at the latest follow-up (p = 0.0001), while this association was not observed with MRI (p = 0.49). pCLE sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 66.7%, 93.5%, 80%, 88.9%, and 86%, respectively. MRI sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 66.7%, 48.4%, 66.7%, 78.9%, and 53.5%, respectively. CONCLUSIONS: pCLE scoring system based on epithelial and vascular features improved the diagnosis of sustained cCR and might be recommended during follow-up. pCLE might add some valuable contribution for identifying local regrowth. Trial Registration This protocol was registered at the Clinical Trials (ClinicalTrials.gov identifier NCT02284802).

A novel approach for the treatment of pelvic abscess: transrectal endoscopic drainage facilitated by transanal endoscopic microsurgery access.

BACKGROUND: Postoperative pelvic abscesses in patients submitted to colorectal surgery are challenging. The surgical approach may be too risky, and image-guided drainage often is difficult due to the complex anatomy of the pelvis. This article describes novel access for drainage of a pelvic collection using a minimally invasive natural orifice approach. METHODS: A 37 year-old man presented with sepsis due to a pelvic abscess during the second postoperative week after a Hartmann procedure due to perforated rectal cancer. Percutaneous drainage was determined by computed tomography to be unsuccessful, and another operation was considered to be hazardous. Because the pelvic fluid was very close to the rectal stump, transrectal drainage was planned. The rectal stump was opened using transanal endoscopic microsurgery (TEM) instruments. The endoscope was advanced through the TEM working channel and the rectal stump opening, accessing the abdominal cavity and pelvic collection. RESULTS: The pelvic collection was endoscopically drained and the local cavity washed with saline through the scope channel. A Foley catheter was placed in the rectal stump. The patient's recovery after the procedure was successful, without the need for further intervention. CONCLUSIONS: Transrectal endoscopic drainage may be an option for selected cases of pelvic fluid collection in patients submitted to Hartmann's procedure. The technique allows not only fluid drainage but also visualization of the local cavity, cleavage of multiloculated abscesses, and saline irrigation if necessary. The use of TEM instrumentation allows safe access to the peritoneal cavity.

Combined artificial intelligence and radiologist model for predicting rectal cancer treatment response from magnetic resonance imaging: an external validation study.

PURPOSE: To evaluate an MRI-based radiomic texture classifier alone and combined with radiologist qualitative assessment in predicting pathological complete response (pCR) using restaging MRI with internal training and external validation. METHODS: Consecutive patients with locally advanced rectal cancer (LARC) who underwent neoadjuvant therapy followed by total mesorectal excision from March 2012 to February 2016 (Memorial Sloan Kettering Cancer Center/internal dataset, n = 114, 41% female, median age = 55) and July 2014 to October 2015 (Instituto do Câncer do Estado de São Paulo/external dataset, n = 50, 52% female, median age = 64.5) were retrospectively included. Two radiologists (R1, senior; R2, junior) independently evaluated restaging MRI, classifying patients (radiological complete response vs radiological partial response). Model A (n = 33 texture features), model B (n = 91 features including texture, shape, and edge features), and two combination models (model A + B + R1, model A + B + R2) were constructed. Pathology served as the reference standard for neoadjuvant treatment response. Comparison of the classifiers' AUCs on the external set was done using DeLong's test. RESULTS: Models A and B had similar discriminative ability (P = 0.3; Model B AUC = 83%, 95% CI 70%-97%). Combined models increased inter-reader agreement compared with radiologist-only interpretation (κ = 0.82, 95% CI 0.70-0.89 vs k = 0.25, 95% CI 0.11-0.61). The combined model slightly increased junior radiologist specificity, positive predictive value, and negative predictive values (93% vs 90%, 57% vs 50%, and 91% vs 90%, respectively). CONCLUSION: We developed and externally validated a combined model using radiomics and radiologist qualitative assessment, which improved inter-reader agreement and slightly increased the diagnostic performance of the junior radiologist in predicting pCR after neoadjuvant treatment in patients with LARC.

ANORECTAL MANOMETRY STANDARD OF A BRAZILIAN POPULATION AT PRODUCTIVE AGE WITHOUT PELVIC FLOOR DISORDERS: A PROSPECTIVE VOLUNTEERED STUDY.

BACKGROUND: Due to the lack of normal standards of anorectal manometry in Brazil, data used are subject to normality patterns described at different nationalities. AIM: To determine the values and range of the parameters evaluated at anorectal manometry in people, at productive age, without pelvic floor disorders comparing the parameters obtained between male and female. METHODS: Prospective analysis of clinical data, such as gender, age, race, body mass index (BMI) and anorectal manometry, of volunteers from a Brazilian university reference in pelvic floor disorders. RESULTS: Forty patients were included, with a mean age of 45.5 years in males and 37.2 females (p=0.43). According to male and female, respectively in mmHg, resting pressures were similar (78.28 vs. 63.51, p=0.40); squeeze pressures (153.89 vs. 79.78, p=0.007) and total squeeze pressures (231.27 vs. 145.63, p=0.002). Men presented significantly higher values of anorectal squeeze pressures, as well as the average length of the functional anal canal (2.85 cm in male vs. 2.45 cm in female, p=0.003). CONCLUSIONS: Normal sphincter pressure levels in Brazilians differ from those used until now as normal literature standards. Male gender has higher external anal sphincter tonus as compared to female, in addition a greater extension of the functional anal canal.