Quantitative Indocyanine Green Fluorescence Imaging Assessment for Nonmucinous Peritoneal Metastases: Preliminary Results of the ICCP Study.

BACKGROUND: In selected patients with peritoneal metastases of colorectal origin, complete cytoreduction has been the main single prognostic factor influencing long-term outcomes. In these patients, indocyanine green fluorescence imaging seems to be useful in detecting small subclinical peritoneal implants. However, quantitative fluorescence analysis has not yet been established as standard. OBJECTIVE: This study aimed to evaluate the sensitivity and specificity of quantitative indocyanine green fluorescence assessment in the detection of peritoneal metastases of nonmucinous colorectal origin. DESIGN: This is a single-center, single-arm, low-intervention prospective trial. SETTINGS: A fluorescence assessment device was used for intraoperative fluorescence quantitative assessment. PATIENTS: Consecutive patients diagnosed with peritoneal metastases of colorectal origin who met the inclusion criteria were selected for curative surgery. INTERVENTIONS: Intravenous indocyanine green was administered 12 hours before surgery. Cytoreduction was performed through nodule identification under white light and then under indocyanine green. Finally, ex vivo fluorescence was assessed. MAIN OUTCOME MEASURES: The primary outcomes measured were the sensitivity and specificity of quantitative fluorescence. RESULTS: The first 11 enrolled patients were included in this preliminary analysis. In total, 52 nodules were resected, with 37 (71.1%) being diagnosed as malignant in the histopathological analysis. Of those, 5 (13.5%) were undetectable under white light and were identified only with fluorescence. A total of 15 nonmalignant nodules were detected under white light, 8 (53.3%) of which were fluorescence negative. Fluorescence greater than 181 units might be the threshold of malignancy, with a sensitivity and specificity of 89.0% and 85.0%, whereas uptake less than 100 units appears to correlate with a benign pathology. LIMITATIONS: The limited sample size, the physiological uptake, and excretion of indocyanine green might interfere with the assessment of unnoticed implants in the bowel serosa and liver. CONCLUSIONS: Quantitative indocyanine green seems to be useful for the assessment of nonmucinous colorectal peritoneal metastases. Fluorescence uptake greater than 181 units appears to correlate with malignancy, whereas uptake less than 100 units appears to correlate with a benign pathology. See Video Abstract at http://links.lww.com/DCR/B743. EVALUACIN CUANTITATIVA DE IMGENES DE FLUORESCENCIA CON VERDE DE INDOCIANINA PARA METSTASIS PERITONEALES NO MUCINOSAS RESULTADOS PRELIMINARES DEL ESTUDIO ICCP: ANTECEDENTES:En pacientes seleccionados con metástasis peritoneales de origen colorrectal, la citorreducción com-pleta ha sido el único factor pronóstico principal que influye en el resultado a largo plazo. En estos pacientes, las imágenes de fluorescencia con verde de indocianina parecen ser útiles para detectar pequeños implantes peritoneales subclínicos. Sin embargo, el análisis cuantitativo de fluorescencia aún no se ha establecido como estándar.OBJETIVO:Evaluar la sensibilidad y especificidad de la evaluación cuantitativa de fluorescencia verde de indo-cianina, en la detección de metástasis peritoneales de origen colorrectal no mucinoso.DISEÑO:Ensayo prospectivo de intervención baja de un solo brazo y un solo centro.ENTORNO CLINICO:El dispositivo se utilizó para la evaluación cuantitativa de fluorescencia intraoperatoria.PACIENTES:Pacientes consecutivos diagnosticados con metástasis peritoneales de origen colorrectal, selecciona-dos para cirugía curativa y que cumplieron con los criterios de inclusión.INTERVENCIONES:Se administró verde de indocianina por vía intravenosa 12 h antes de la cirugía. La citorreducción se realizó mediante identificación de nódulos con luz blanca y luego con verde de indocianina. Final-mente, se evaluó la fluorescencia ex vivo.PRINCIPALES MEDIDAS DE VALORACION:Sensibilidad y especificidad cuantitativa de la fluorescencia.RESULTADOS:Los primeros 11 pacientes fueron incluidos en este análisis preliminar. En total se resecaron 52 nódu-los, siendo 37 (71,1%) diagnosticados como malignos en el análisis histopatológico. De ellos, 5 (13,5%) eran indetectables bajo luz blanca y solamente se identificaron con fluorescencia. Se detec-taron un total de 15 nódulos no malignos bajo luz blanca, de los cuales 8 (53,3%) fueron fluorescen-tes negativos. La fluorescencia superior a 181 unidades podría ser el umbral de malignidad, con una sensibilidad y especificidad del 89,0% y el 85,0% respectivamente; mientras que la captación por debajo de 100 unidades parece correlacionarse con una patología benigna.LIMITACIONES:El tamaño limitado de la muestra; la captación fisiológica y la excreción de verde de indocianina pueden interferir con la evaluación de implantes inadvertidos en la serosa intestinal y el hígado.CONCLUSIONES:La cuantificación del verde de indocianina, parece ser útil en la evaluación de metástasis peritonea-les colorrectales no mucinosas. La captación de fluorescencia por encima de 181 unidades parece correlacionarse con la malignidad, mientras que la captación por debajo de 100 unidades parece co-rrelacionarse con una patología benigna. Consulte Video Resumen en http://links.lww.com/DCR/B743. (Traducción - Dr. Fidel Ruiz Healy).

Surgical Quality Assurance in COLOR III: Standardization and Competency Assessment in a Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to develop an objective and reliable surgical quality assurance system (SQA) for COLOR III, an international multicenter randomized controlled trial (RCT) comparing transanal total mesorectal excision (TaTME) with laparoscopic approach for rectal cancer. BACKGROUND OF SUMMARY DATA: SQA influences outcome measures in RCTs such as lymph nodes harvest, in-hospital mortality, and locoregional cancer recurrence. However, levels of SQA are variable. METHOD: Hierarchical task analysis of TaTME was performed. A 4-round Delphi methodology was applied for standardization of TaTME steps. Semistructured interviews were conducted in round 1 to identify key steps and tasks, which were rated as mandatory, optional, or prohibited in rounds 2 to 4 using questionnaires. Competency assessment tool (CAT) was developed and its content validity was examined by expert surgeons. Twenty unedited videos were assessed to test reliability using generalizability theory. RESULTS: Eighty-three of 101 surgical tasks identified reached 70% agreement (26 mandatory, 56 optional, and 1 prohibited). An operative guide of standardized TaTME was created. CAT is matrix of 9 steps and 4 performance qualities: exposure, execution, adverse event, and end-product. The overall G-coefficient was 0.883. Inter-rater and interitem reliability were 0.883 and 0.986. To enter COLOR III, 2 unedited TaTME and 1 laparoscopic TME videos were submitted and assessed by 2 independent assessors using CAT. CONCLUSION: We described an iterative approach to develop an objective SQA within multicenter RCT. This approach provided standardization, the development of reliable and valid CAT, and the criteria for trial entry and monitoring surgical performance during the trial.

Laparoscopic versus open sigmoid resection for diverticular disease: follow-up assessment of the randomized control Sigma trial.

BACKGROUND: The short-term results of the Sigma trial show that laparoscopic sigmoid resection (LSR) used electively for diverticular disease offers advantages over open sigmoid resection (OSR). This study aimed to compare the overall mortality and morbidity rates after evaluation of the clinical outcomes at the 6-month follow-up evaluation. METHODS: In a prospective, multicenter, double-blind, parallel-arm, randomized control trial, eligible patients were randomized to either LSR or OSR. The short-term results and methodologic details have been published previously. Follow-up evaluation was performed at the outpatient clinic 6 weeks and 6 months after surgery. RESULTS: In this trial, 104 patients were randomized for either LSR or OSR, and the conversion rate was 19.2%. The LSR approach was associated with short-term benefits such as a 15.4% reduction in the major complications rate, less pain, and a shorter hospital stay at the cost of a longer operating time. At the 6-month follow-up evaluation, no significant differences in morbidity or mortality rates were found. Two patients died of cardiac causes (overall mortality, 3%). Late complications (7 LSR vs. 12 OSR; p = 0.205) consisted of three incisional hernias, five small bowel obstructions, four enterocutaneous fistulas, one intraabdominal abscess, one retained gauze, two anastomotic strictures, and three recurrent episodes of diverticulitis. Nine of these patients underwent additional surgical interventions. Consideration of the major morbidity over the total follow-up period (0-6 months) shows that the LSR patients experienced significantly fewer complications than the OSR patients (9 LSR vs. 23 OSR; p = 0.003). The Short Form-36 (SF-36) questionnaire showed significantly better quality of life for LSR at the 6-week follow-up assessment. However, at the 6-month follow-up assessment, these differences were decreased. CONCLUSIONS: The late clinical outcomes did not differ between LSR and OSR during the 30-day to 6-month follow-up period. Consideration of total postoperative morbidity shows a 27% reduction in major morbidity for patients undergoing laparoscopic surgery for diverticular disease.