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2.
Curr Opin Gastroenterol ; 39(5): 448-454, 2023 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-37097824

RESUMO

PURPOSE OF REVIEW: Patients with pancreatic tumors may have limited treatment options. Pancreatic tumor ablation is a novel and emerging treatment modality which can now be performed using endoscopic ultrasound (EUS) guidance. This modality is well suited to guide energy delivery for radiofrequency ablation (RFA) and microwave ablation. These approaches provide minimally invasive, nonsurgical methods for delivering energy to ablate pancreatic tumors in situ . This review summarizes the current data and safety profile for ablation in managing pancreatic cancer and pancreatic neuroendocrine tumors. RECENT FINDINGS: RFA uses thermal energy to induce cell death by coagulative necrosis and protein denaturation. Studies have reported increased overall survival in patients with pancreatic tumors treated with EUS-guided RFA in a multimodality systemic approach and when used in palliative surgeries. Radiofrequency ablation may have corollary benefits in inducing an immune-modulatory effect. Tumor marker carbohydrate antigen 19-9 has been reported to decrease in response to RFA. Microwave ablation is an emerging modality. SUMMARY: RFA utilizes focal thermal energy to induce cell death. RFA has been applied through open, laparoscopic, and radiographic modalities. EUS-guided approaches are now allowing RFA and microwave ablation to be performed for pancreatic tumors in situ .


Assuntos
Ablação por Cateter , Laparoscopia , Neoplasias Pancreáticas , Ablação por Radiofrequência , Humanos , Neoplasias Pancreáticas/cirurgia , Neoplasias Pancreáticas/patologia , Ablação por Radiofrequência/métodos , Pâncreas/cirurgia , Endossonografia/métodos , Ablação por Cateter/métodos
3.
Ann Surg ; 277(5): e1072-e1080, 2023 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-35129503

RESUMO

OBJECTIVE: We evaluated a protocolized endoscopic necrosectomy approach with a lumen-apposing metal stent (LAMS) in patients with large symptomatic walled-off pancreatic necrosis (WON) comprising significant necrotic content, with or without infection. SUMMARY BACKGROUND DATA: Randomized trials have shown similar efficacy of endoscopic treatment compared with surgery for infected WON. DESIGN: We conducted a regulatory, prospective, multicenter single-arm clinical trial examining the efficacy and safety of endoscopic ultrasound -guided LAMS with protocolized necrosectomy to treat symptomatic WON ≥6 cm in diameter with >30% solid necrosis. After LAMS placement, protocolized WON assessment was conducted and endoscopic necrosectomy was performed for insufficient WON size reduction and persistent symptoms. Patients with radiographic WON resolution to ≤ 3 cm and/or 60-day LAMS indwell had LAMS removal, then 6-month follow-up. Primary endpoints were probability of radiographic resolution by 60 days and procedure-related serious adverse events. RESULTS: Forty consecutive patients were enrolled September 2018 to March 2020, of whom 27 (67.5%) were inpatients and 19 (47.5%) had clinical evidence of infection at their index procedure. Mean WON size was 15.0 ± 5.6 cm with mean 53.2% ± 16.7% solid necrosis. Radiographic WON resolution was seen in 97.5% (95% CI, 86.8%, 99.9%) by 60 days, without recurrence in 34 patients with 6-month follow-up data. Mean time to radiographic WON resolution was 34.1 ± 16.8 days. Serious adverse events occurred in 3 patients (7.5%), including sepsis, vancomycin-resistant enterococcal bacteremia and shock, and upper gastrointestinal bleeding. There were no procedure-related deaths. CONCLUSIONS: Endoscopic ultrasound-guided drainage with protocolized endoscopic necrosectomy to treat large symptomatic or infected walled-off necrotic pancreatic collections was highly effective and safe. Clinicaltrials.-gov no: NCT03525808.


Assuntos
Pancreatite Necrosante Aguda , Humanos , Drenagem/métodos , Endossonografia , Metais , Necrose/etiologia , Necrose/cirurgia , Pancreatite Necrosante Aguda/diagnóstico por imagem , Pancreatite Necrosante Aguda/cirurgia , Estudos Prospectivos , Estudos Retrospectivos , Stents/efeitos adversos , Resultado do Tratamento
4.
Am Surg ; 89(11): 4459-4468, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-35575200

RESUMO

BACKGROUND: Necrotizing pancreatitis (NP) may result de novo or following procedures such as ERCP or partial pancreatectomy (post-procedural), and may require surgical debridement. Video-assisted retroperitoneal debridement (VARD) is a standard approach for NP that employs a 5 cm incision with varying degrees of blind and open debridement. We describe our technique and outcomes of a modified VARD called laparoscopic-assisted pancreatic necrosectomy (LAPN) performed through a single 12 mm incision that uses direct laparoscopic visualization during debridement. METHODS: At one medical center, all LAPN patients (2012-2020) were assessed for demographics, disease factors, and outcomes. Bivariate logistic regression analyses were performed to identify factors independently associated with recovery after LAPN for patients with de novo vs post-procedural necrosum. RESULTS: Over 9 years, 60 patients underwent LAPN for NP. Median age was 57 years (IQR: 47-66) and 43 (69%) were men. Pancreas necrosum was de novo in 39 (63%) patients and post-procedural in 23 (37%). NP resolved with a median of 1 LAPN procedure and median hospitalization was 33 days. The LAPN major morbidity rate and in-hospital mortality rate were 47% and 5%. No significant differences were seen between NP etiology cohorts, although post-procedure NP patients trended towards a faster clinical recovery to baseline compared to de novo patients (193 vs 394 days; p-value = .07). CONCLUSIONS: LAPN offers a smaller incision with excellent visualization and non-inferior outcomes, regardless of etiology, with likely faster recovery for patients with post-procedural vs de novo necrotizing pancreatitis.


Assuntos
Laparoscopia , Pancreatite Necrosante Aguda , Masculino , Humanos , Pessoa de Meia-Idade , Feminino , Desbridamento/métodos , Pâncreas/cirurgia , Laparoscopia/métodos , Pancreatite Necrosante Aguda/cirurgia , Espaço Retroperitoneal/cirurgia , Drenagem/métodos , Resultado do Tratamento
5.
Ann Surg ; 278(3): e556-e562, 2023 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-36537290

RESUMO

OBJECTIVE: To evaluate the safety and efficacy of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using a lumen-apposing metal stent (LAMS). BACKGROUND: For patients with acute cholecystitis who are poor surgical candidates, EUS-GBD using a LAMS is an important treatment alternative to percutaneous gallbladder drainage. METHODS: We conducted a regulatory-compliant, prospective multicenter trial at 7 tertiary referral centers in the United States of America and Belgium. Thirty consecutive patients with mild or moderate acute cholecystitis who were not candidates for cholecystectomy were enrolled between September 2019 and August 2021. Eligible patients had a LAMS placed transmurally with 30 to 60-day indwell if removal was clinically indicated, and 30-day follow-up post-LAMS removal. Endpoints included days until acute cholecystitis resolution, reintervention rate, acute cholecystitis recurrence rate, and procedure-related adverse events (AEs). RESULTS: Technical success was 93.3% (28/30) for LAMS placement and 100% for LAMS removal in 19 patients for whom removal was attempted. Five (16.7%) patients required reintervention. Mean time to acute cholecystitis resolution was 1.6±1.5 days. Acute cholecystitis symptoms recurred in 10.0% (3/30) after LAMS removal. Five (16.7%) patients died from unrelated causes. Procedure-related AEs were reported to the FDA in 30.0% (9/30) of patients, including one fatal event 21 days after LAMS removal; however, no AEs were causally related to the LAMS. CONCLUSIONS: For selected patients with acute cholecystitis who are at elevated surgical risk, EUS-GBD with LAMS is an alternative to percutaneous gallbladder drainage. It has high technical and clinical success, with low recurrence and an acceptable AE rate. Clinicaltrials.gov, Number: NCT03767881.


Assuntos
Colecistite Aguda , Vesícula Biliar , Humanos , Vesícula Biliar/diagnóstico por imagem , Vesícula Biliar/cirurgia , Estudos Prospectivos , Resultado do Tratamento , Colecistite Aguda/diagnóstico por imagem , Colecistite Aguda/cirurgia , Endossonografia , Drenagem/efeitos adversos , Stents , Ultrassonografia de Intervenção
6.
Curr Opin Gastroenterol ; 38(6): 581-587, 2022 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-36219126

RESUMO

PURPOSE OF REVIEW: Gastric submucosal mass lesions are a collection of tumours that arise in the stomach and are deep to the mucosal layer. Distinct from gastric epithelial carcinomas, these tumours are generally more indolent. They are often found incidentally on upper endoscopy. Most often they present as smooth protuberant masses covered by normal intact gastric mucosa. The majority are asymptomatic. Endoscopic ultrasound (EUS) is frequently employed to further characterize the lesions. EUS can be diagnostic of some lesions, such as lipomas, and can be used to guide fine needle aspiration to diagnose others. Adding to the traditional management approaches of observation and surgical resection, numerous new and emerging endoscopic therapies are now being used to resect these gastric tumours. RECENT FINDINGS: This review focuses on evolving strategies in the diagnosis and management of submucosal mass lesions. Although surgical intervention was once the lone option for intervention, there are an increasing number of endoscopic therapies. There have also been advancements in neoadjuvant therapies and in distinguishing the malignant potential of submucosal mass lesions. SUMMARY: Gastric submucosal lesions are common. EUS is frequently indicated in the evaluation and diagnosis. For tumours for which observation is not recommended, novel endoscopic therapies may offer less invasive management options.


Assuntos
Neoplasias Gástricas , Endossonografia , Gastroscopia , Humanos , Neoplasias Gástricas/diagnóstico , Neoplasias Gástricas/cirurgia
7.
Clin Endosc ; 55(3): 372-380, 2022 May.
Artigo em Inglês | MEDLINE | ID: mdl-35144364

RESUMO

BACKGROUND/AIMS: Endoscopic resection has become the preferred treatment approach for select early esophageal adenocarcinoma (EAC); however, the epidemiology of early stage disease has not been well defined. METHODS: Surveillance Epidemiology and End Results (SEER) data were analyzed to determine age-adjusted incidence rates among major epithelial carcinomas, including EAC, from 1973 to 2017. The percent change in incidence over time was compared according to tumor subtype. Early T-stage, node-negative EAC without metastasis was examined from 2004 to 2017 when precise T-stage data were available. RESULTS: The percent change in annual incidence from 1973 to 2017 was 767% for EAC. Joinpoint analysis showed that the average annual percent change in EAC from 1973 to 2017 was 5.11% (95% confidence interval, 4.66%-5.56%). The annual percent change appeared to plateau between 2004 and 2017; however, early EAC decreased from 2010 to 2017, with an annual percent change of -5.78%. CONCLUSION: There has been a 7-fold increase in the incidence of EAC, which was significantly greater than that of the other major epithelial malignancies examined. More recently, the incidence of early EAC has been decreasing. Approximately one in five patients has node negative, potentially resectable early stage disease.

8.
Surg Endosc ; 36(6): 3876-3883, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-34463872

RESUMO

BACKGROUND: Endoscopic management of early gastric cancer is limited by the risk of lymph node metastasis. We aimed to examine the incidence and predictors of nodal metastasis in early gastric adenocarcinoma in a large national US cohort. METHODS: Cases were abstracted from the National Cancer Database from 2004 to 2016. The incidence and predictors of lymph node involvement for patients with Tis, T1a, and T1b tumors were examined. RESULTS: A total of 202,216 cases of gastric adenocarcinoma were identified in the NCDB. Cases with unknown patient or tumor characteristics, presence of other cancers, and prior neoadjuvant chemotherapy or radiotherapy were excluded. 1839 cases of Tis, T1a, and T1b tumors were identified. Lymph node metastases were present in 18.1% of patients. Lymphovascular invasion (LVI), high-grade histology, stage T1b, and larger size (> 3 cm) were independently associated with an increased risk of nodal metastasis on multivariate analysis (P < 0.05). The presence of LVI was the strongest predictor of nodal metastasis with an OR (95% CI) of 5.7 (4.3-7.6), P < 0.001. No lymph node metastasis was found in any Tis tumors. Small T1a low-grade tumors with no LVI had a low risk of nodal metastasis (0.6% < 2 cm and 0.9% < 3 cm). CONCLUSION: In this large national cohort, size, lymphovascular invasion, higher grade histology, and T stage were independently associated with lymph node metastasis. For patients with low-grade tumors, < 3 cm, without lymphovascular invasion, the risk of nodal involvement was very low, suggesting that this Western cohort could be considered for endoscopic resection.


Assuntos
Adenocarcinoma , Neoplasias Gástricas , Adenocarcinoma/cirurgia , Humanos , Linfonodos/patologia , Metástase Linfática/patologia , Invasividade Neoplásica/patologia , Estadiamento de Neoplasias , Estudos Retrospectivos , Neoplasias Gástricas/cirurgia
9.
Surg Laparosc Endosc Percutan Tech ; 32(1): 114-118, 2021 Sep 27.
Artigo em Inglês | MEDLINE | ID: mdl-34570074

RESUMO

INTRODUCTION: Per-oral endoscopic myotomy (POEM) has been widely adopted for the treatment of achalasia as it provides a precise, tailored myotomy in a minimally invasive endoscopic procedure. Several short-term studies and a few long-term studies have confirmed that POEM is a safe and effective treatment for achalasia. However, the long-term outcome of POEM performed by trainees is unknown. MATERIALS AND METHODS: We conducted a retrospective study of all patients who underwent POEM for achalasia at our tertiary care center during December 2012 and January 2019. All procedures performed with trainees were included. The primary outcome was the clinical response to POEM, defined as an Eckardt score of <3 after POEM. Trainees were trained in performing mucosotomy and submucosal dissection, creating a submucosal tunnel, identifying gastroesophageal junction, and performing myotomy and closure of mucosal incision in a step-by-step fashion. Trainees' performance was evaluated by the mentor based on several key points in each step. RESULTS: A total of 153 consecutive patients with a median age of 57±18 years were analyzed in this study. Of the total patients, 69 (45%) were male. The median length of follow-up after POEM was 32 months (range: 7 to 77 mo). A clinically significant response to POEM was achieved in 95% of patients at year 1, 84% at year 2, 80% at year 3, 79% at year 4, 78% at year 5, and 78% at year 6 and above. All trainees obtained competence within 6 cases for each step and could perform the procedure alone after 20 supervised cases. CONCLUSIONS: Overall, 78% of patients maintained positive clinical response at 6 years following POEM procedure. The recurrence rate of symptoms following POEM was 22% at a 6-year follow-up. This long-term outcome of POEM performed with trainees was comparable to those without trainees in other studies. To our knowledge, this is the longest follow-up and the largest number of patients after the POEM procedure performed with trainees.


Assuntos
Acalasia Esofágica , Miotomia , Cirurgia Endoscópica por Orifício Natural , Adulto , Idoso , Endoscopia Gastrointestinal , Acalasia Esofágica/cirurgia , Esfíncter Esofágico Inferior/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento
10.
Am Soc Clin Oncol Educ Book ; 41: 158-168, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-34010045

RESUMO

During the past 30 years, radiation treatment techniques have significantly improved, from conventional external-beam radiation therapy, to three-dimensional conformal radiation therapy, to current intensity-modulated radiation therapy, benefiting patients who undergo treatment of pelvic malignancies. Modern treatment options also include proton beam irradiation as well as low and high dose rate brachytherapy. Although the acute adverse effects of these modalities are well documented in clinical trials, less well known are the true incidence and optimal management of those late adverse effects that can occur months to years later. In a population of survivors of cancer that is steadily increasing, with many such patients receiving radiotherapy at some time during their disease course, these late effects can become a considerable management and quality-of-life issue. This review will examine the range of late toxicities that can occur from pelvic radiotherapy and explore strategies to prevent and mitigate them.


Assuntos
Braquiterapia , Neoplasias da Próstata , Radioterapia Conformacional , Radioterapia de Intensidade Modulada , Braquiterapia/efeitos adversos , Humanos , Masculino , Pelve , Radioterapia/efeitos adversos , Dosagem Radioterapêutica , Radioterapia de Intensidade Modulada/efeitos adversos
11.
Am J Gastroenterol ; 116(4): 700-709, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33982939

RESUMO

INTRODUCTION: Endoscopic necrosectomy has emerged as the preferred treatment modality for walled-off pancreatic necrosis. This study was designed to evaluate the safety and efficacy of direct endoscopic necrosectomy with and without hydrogen peroxide (H2O2) lavage. METHODS: Retrospective chart reviews were performed for all patients undergoing endoscopic transmural management of walled-off pancreatic necrosis at 9 major medical centers from November 2011 to August 2018. Clinical success was defined as the resolution of the collection by imaging within 6 months, without requiring non-endoscopic procedures or surgery. RESULTS: Of 293 patients, 204 met the inclusion criteria. Technical and clinical success rates were 100% (204/204) and 81% (166/189), respectively. For patients, 122 (59.8%) patients had at least one H2O2 necrosectomy (H2O2 group) and 82 (40.2%) patients had standard endoscopic necrosectomy. Clinical success was higher in the H2O2 group: 106/113 (93.8%) vs 60/76 (78.9%), P = 0.002. On a multivariate analysis, the use of H2O2 was associated with higher clinical success rate (odds ratio 3.30, P = 0.033) and earlier resolution (odds ratio 2.27, P < 0.001). During a mean follow-up of 274 days, 27 complications occurred. Comparing procedures performed with and without H2O2 (n = 250 vs 183), there was no difference in post-procedure bleeding (7 vs 9, P = 0.25), perforation (2 vs 3, P = 0.66), infection (1 vs 2, P = 0.58), or overall complication rate (n = 13 [5.2%] vs 14 [7.7%], P = 0.30). DISCUSSION: H2O2-assisted endoscopic necrosectomy had a higher clinical success rate and a shorter time to resolution with equivalent complication rates relative to standard necrosectomy.See the visual abstract at http://links.lww.com/AJG/B714.(Equation is included in full-text article.).


Assuntos
Endoscopia do Sistema Digestório/métodos , Peróxido de Hidrogênio/uso terapêutico , Pancreatite Necrosante Aguda/terapia , Anti-Infecciosos Locais/uso terapêutico , Drenagem/métodos , Endossonografia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Pancreatite Necrosante Aguda/diagnóstico , Estudos Retrospectivos
12.
Am Soc Clin Oncol Educ Book ; 41: 1-11, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33793314

RESUMO

Pelvic radiation therapy is an integral component in the treatment of various gastrointestinal, gynecologic, and genitourinary cancers. As survival rates from these malignancies improve, the prevalence of toxicity secondary to pelvic radiation has increased. Gastrointestinal toxicities are the most common complications and greatly impact quality of life. Toxicities can present in acute or late stages; although symptoms may be similar during both, the management may differ. Acute toxicities represent an inflammatory reaction in response to the radiation exposure, whereas late toxicities may arise as a result of small vessel disease, ischemia, and fibrosis. Currently, there are no large clinical trials and only limited guidelines on the management of late gastrointestinal radiation toxicities. Therapy is generally approached in a stepwise manner from medical to endoscopic to surgical methods. Several endoscopic therapies, such as the treatment of radiation proctitis with argon plasma coagulation and dilation of radiation bowel strictures, may prevent the need for surgical intervention, which may be associated with high morbidity and mortality. Given that late toxicities can occur years after radiation therapy, they are often difficult to recognize and diagnose. Successful management of late toxicities requires recognition, an understanding of the underlying pathophysiology, and a multidisciplinary approach. More dedicated research could clarify the prevalence of gastrointestinal pelvic radiation toxicities, permit a better understanding of the efficacy and safety profile of current therapies, and allow for the development of novel therapeutic approaches.


Assuntos
Proctite , Lesões por Radiação , Feminino , Humanos , Pelve , Proctite/diagnóstico , Proctite/epidemiologia , Proctite/etiologia , Qualidade de Vida , Lesões por Radiação/diagnóstico , Lesões por Radiação/epidemiologia , Lesões por Radiação/etiologia
14.
Pancreas ; 50(3): 327-329, 2021 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-33835962

RESUMO

OBJECTIVES: The exact prevalence for intraductal papillary mucinous neoplasm (IPMN) in patients with chronic kidney disease (CKD) remains unknown. In this single-center case-control study, we aimed to study the prevalence and risk factors for IPMN in patients with CKD. METHODS: We performed a retrospective case-control study comparing patients with and without CKD who had magnetic resonance imaging of the abdomen performed between January 2018 and December 2018. Patient demographic, clinical, and imaging metrics were extracted from chart review. The prevalence of IPMN was compared between the 2 groups. RESULTS: A total of 800 patient charts were reviewed. There were 400 patients with CKD compared with an age-matched control group of 400 patients without CKD. The total prevalence of IPMN in patients with CKD was 13.7% (55/400) compared with 7.8% (29/400; P = 0.002) in non-CKD patients. The prevalence of diabetes mellitus was significantly higher in the CKD group (41% vs 14%, P = 0.0001). The percentage of patients consuming alcohol was significantly higher in the non-CKD group (23% vs 35%, P = 0.002). CONCLUSIONS: Patients with CKD have a significantly higher prevalence of IPMN compared with non-CKD patients. Larger population-based studies are needed to confirm these findings.


Assuntos
Adenocarcinoma Mucinoso/diagnóstico , Carcinoma Ductal Pancreático/diagnóstico , Neoplasias Pancreáticas/diagnóstico , Insuficiência Renal Crônica/diagnóstico , Adenocarcinoma Mucinoso/diagnóstico por imagem , Adenocarcinoma Mucinoso/epidemiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Carcinoma Ductal Pancreático/diagnóstico por imagem , Carcinoma Ductal Pancreático/epidemiologia , Estudos de Casos e Controles , Comorbidade , Feminino , Humanos , Imageamento por Ressonância Magnética/métodos , Masculino , Pessoa de Meia-Idade , Neoplasias Pancreáticas/diagnóstico por imagem , Neoplasias Pancreáticas/epidemiologia , Prevalência , Insuficiência Renal Crônica/diagnóstico por imagem , Insuficiência Renal Crônica/epidemiologia , Estudos Retrospectivos , Medição de Risco/métodos , Medição de Risco/estatística & dados numéricos , Fatores de Risco
15.
Clin Gastroenterol Hepatol ; 19(6): 1282-1284, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-32454259

RESUMO

Percutaneous transhepatic biliary drainage (PTBD) and endoscopic retrograde cholangiopancreatography (ERCP) are widely accepted but competing approaches for the management of malignant obstruction at the hilum of the liver. ERCP is favored in the United States on the basis of high success rates for non-hilar indications, the perceived safety and superior tissue sampling capability of ERCP relative to PTBD, and the avoidance of external drains that are undesirable to patients. A recent randomized controlled trial (RCT) comparing the 2 modalities in patients with resectable hilar cholangiocarcinoma was terminated prematurely because of higher mortality in the PTBD group.1 In contrast, most observational data suggest that PTBD is superior for achieving complete drainage.2-6 Because the preferred procedure remains uncertain, we aimed to compare PTBD and ERCP as the primary intervention in patients with cholestasis due to malignant hilar obstruction (MHO).


Assuntos
Neoplasias dos Ductos Biliares , Colestase , Neoplasias dos Ductos Biliares/complicações , Ductos Biliares Intra-Hepáticos , Colangiopancreatografia Retrógrada Endoscópica , Colestase/cirurgia , Drenagem , Endossonografia , Humanos
16.
N Engl J Med ; 383(11): 1028-1039, 2020 09 10.
Artigo em Inglês | MEDLINE | ID: mdl-32905675

RESUMO

BACKGROUND: The efficacy and safety of combination therapy with eflornithine and sulindac, as compared with either drug alone, in delaying disease progression in patients with familial adenomatous polyposis are unknown. METHODS: We evaluated the efficacy and safety of the combination of eflornithine and sulindac, as compared with either drug alone, in adults with familial adenomatous polyposis. The patients were stratified on the basis of anatomical site with the highest polyp burden and surgical status; the strata were precolectomy (shortest projected time to disease progression), rectal or ileal pouch polyposis after colectomy (longest projected time), and duodenal polyposis (intermediate projected time). The patients were then randomly assigned in a 1:1:1 ratio to receive 750 mg of eflornithine, 150 mg of sulindac, or both once daily for up to 48 months. The primary end point, assessed in a time-to-event analysis, was disease progression, defined as a composite of major surgery, endoscopic excision of advanced adenomas, diagnosis of high-grade dysplasia in the rectum or pouch, or progression of duodenal disease. RESULTS: A total of 171 patients underwent randomization. Disease progression occurred in 18 of 56 patients (32%) in the eflornithine-sulindac group, 22 of 58 (38%) in the sulindac group, and 23 of 57 (40%) in the eflornithine group, with a hazard ratio of 0.71 (95% confidence interval [CI], 0.39 to 1.32) for eflornithine-sulindac as compared with sulindac (P = 0.29) and 0.66 (95% CI, 0.36 to 1.24) for eflornithine-sulindac as compared with eflornithine. Among 37 precolectomy patients, the corresponding values in the treatment groups were 2 of 12 patients (17%), 6 of 13 (46%), and 5 of 12 (42%) (hazard ratios, 0.30 [95% CI, 0.07 to 1.32] and 0.20 [95% CI, 0.03 to 1.32]); among 34 patients with rectal or ileal pouch polyposis, the values were 4 of 11 patients (36%), 2 of 11 (18%), and 5 of 12 (42%) (hazard ratios, 2.03 [95% CI, 0.43 to 9.62] and 0.84 [95% CI, 0.24 to 2.90]); and among 100 patients with duodenal polyposis, the values were 12 of 33 patients (36%), 14 of 34 (41%), and 13 of 33 (39%) (hazard ratios, 0.73 [95% CI, 0.34 to 1.52] and 0.76 [95% CI, 0.35 to 1.64]). Adverse and serious adverse events were similar across the treatment groups. CONCLUSIONS: In this trial involving patients with familial adenomatous polyposis, the incidence of disease progression was not significantly lower with the combination of eflornithine and sulindac than with either drug alone. (Funded by Cancer Prevention Pharmaceuticals; ClinicalTrials.gov number, NCT01483144; EudraCT number, 2012-000427-41.).


Assuntos
Polipose Adenomatosa do Colo/tratamento farmacológico , Progressão da Doença , Eflornitina/uso terapêutico , Sulindaco/uso terapêutico , Adulto , Quimioterapia Combinada , Eflornitina/efeitos adversos , Feminino , Humanos , Análise de Intenção de Tratamento , Estimativa de Kaplan-Meier , Masculino , Sulindaco/efeitos adversos , Resultado do Tratamento
17.
J Pediatr Gastroenterol Nutr ; 70(5): 568-573, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-31939863

RESUMO

INTRODUCTION: This study was designed to evaluate outcomes in pediatric patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) as compared with an American Society of Gastrointestinal Endoscopy (ASGE) complexity grade-matched adult cohort. METHOD: In this retrospective case-control study, ERCPs performed in pediatric patients from January 2008 to December 2018 in 2 tertiary referral hospitals were compared with a complexity-matched adult control group with similar procedural indications. Primary outcomes included the clinical success rate, technical success rate, and complication rate. Secondary outcomes included postprocedural admission rates, mode of sedation, procedure time, fluoroscopy time, hospitalization length, and the number of repeat procedures. RESULTS: Two hundred thirty-two ERCPs performed in 110 pediatric patients (average age 13.3) and 318 ERCPs performed in 160 ASGE grade-matched adult controls (average age 47.2 years) were analyzed. All procedures were therapeutic. There was no difference in the technical success rate (P = 0.2), clinical success rate (P = 0.5), complication rates (P = 0.1), and fluoroscopy time (P = 0.4), between the pediatric and adult cohorts. General anesthesia use and length of stay were significantly higher in the pediatric group (P = 0.0001). In subgroup analysis, technical (P = 0.2) and clinical success (P = 0.2) as well as complication rates (P = 0.6) were comparable between patients 10 years or less and patients 11 to 18 years within pediatric cohort. CONCLUSIONS: ERCP in pediatric cohorts appears to be safe and effective with equivalent outcomes relative to an ASGE complexity-matched adult cohort. Pediatric patients are more likely to require general anesthesia and have a longer average length of stay relative to adult controls.


Assuntos
Colangiopancreatografia Retrógrada Endoscópica , Endoscopia Gastrointestinal , Adolescente , Adulto , Estudos de Casos e Controles , Criança , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Estudos de Coortes , Humanos , Pessoa de Meia-Idade , Estudos Retrospectivos
18.
Gastroenterol Rep (Oxf) ; 8(6): 425-430, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33442474

RESUMO

BACKGROUND: Fluoroscopy is often used during the endoscopic drainage of pancreatic-fluid collections (PFCs). An electrocautery-enhanced coaxial lumen-apposing, self-expanding metal stent (ELAMS) facilitates a single-step procedure and may avoid the need for fluoroscopy. This study compares the treatment outcomes using ELAMS with and without fluoroscopy. METHODS: Patients with PFCs who had cystogastrostomy from January 2014 to February 2017 were enrolled. Two groups were studied based on fluoroscopy use. Technical success was defined as uneventful insertion of ELAMS at time of procedure. Clinical success was defined as (i) clinical resolution of symptoms after the procedure and (ii) >75% reduction in cyst size on computed tomography 8 weeks after stent placement. Adverse events including bleeding, stent migration, and infection were recorded. RESULTS: A total of 21 patients (13 males) had PFCs drainage with ELAMS in the study period. The mean age was 51.6 ± 14.2 years. Thirteen patients had walled-off necrosis while eight had a pancreatic pseudocyst. The mean size of the PFCs was 11.3 ± 3.3 cm. Fluoroscopy was used in seven cases (33%) and was associated with a longer procedure time compared to non-fluoroscopy (43.1 ± 10.4 vs 33.3 ± 10.5 min, P = 0.025). This association was independent of the size, location, or type of PFCs. Fluoroscopy had no effect on the technical success rates. In fluoroless procedures, the clinical resolution was 91% as compared to 71% in fluoroscopy procedures (P = 0.52) and the radiologic resolution was 57% as compared to 71% in fluoroscopy procedures (P = 0. 65). Three cases of stent migration/displacement occurred in the fluoroless procedures. CONCLUSIONS: ELAMS may avoid the need for fluoroscopy during cystogastrostomy. Procedures without fluoroscopy were significantly shorter and fluoroscopy use had no impact on the technical or clinical success rates.

19.
Pancreas ; 48(10): 1343-1347, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31688599

RESUMO

OBJECTIVE: This study was designed to assess the diagnostic accuracy of standard nonsecretin-enhanced preprocedural magnetic resonance imaging/cholangiopancreatography (MRI/MRCP) in patients with and without pancreas divisum. METHODS: Patients undergoing MRI/MRCP followed by endoscopic retrograde cholangiopancreatography with between 2009 and 2016 were reviewed. The diagnostic accuracy of the MRI/MRCP was evaluated against the pancreatography. A subsequent independent blinded re-review performed by an expert abdominal radiologist was also evaluated. Multivariate binary logistic regression was performed to assess the impact of clinicopathologic factors on the diagnostic accuracy. RESULTS: A total of 189 patients were included in analysis. The sensitivity, specificity, positive predictive value, and negative predictive value of MRI/MRCP for pancreas divisum were 63%, 97%, 94%, and 82% initially and 81%, 91%, 91%, and 82% on the expert review. Motion artifact, the presence of pancreatic tumor, and pancreatic necrosis were not found to significantly impact the accuracy. A normal diameter pancreatic duct (P = 0.04) and complete divisum anatomy were correlated with improved accuracy (P = 0.001). CONCLUSIONS: Although expert review, normal duct diameter, and complete divisum are associated with increased sensitivity, pancreas divisum may be uncharacterized by preprocedural MRI in 19% to 37% of patients before the index endoscopic retrograde cholangiopancreatography.


Assuntos
Colangiopancreatografia por Ressonância Magnética/métodos , Imageamento por Ressonância Magnética/métodos , Pâncreas/anormalidades , Pâncreas/diagnóstico por imagem , Colangiopancreatografia Retrógrada Endoscópica , Feminino , Humanos , Modelos Logísticos , Masculino
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