Effect of Fluorescent Imaging using Indocyanine Green on Surgical Morbidity during MinimallyInvasive Surgery for Oesophageal Cancer (IndoCinMIE): A Phase2 Randomized Controlled Trial

Esophagectomy is still the mainstreammultidisciplinary treatment for esophageal cancer in combination withchemoradiotherapy. Anastomotic leakage (AL) after esophagectomy is one of themost dreaded postoperative complications, and is responsible for higherpostoperative morbidity and mortality rates, prolonged hospital stays, and theneed for further surgical procedures. Anastomotic tension, location ofanastomosis, surgical technique, and postoperative factors, are modifiablefactors when AL is concerned, and many efforts have been made to decrease AL inthe last decades. Vascular perfusion to the anastomotic regions is consideredto be the main driving force of AL. As a means of evaluating blood flow, indocyaninegreen (ICG) fluorescence angiography (FA) has recently been introduced toprovide real-time assessment of the anastomosis area during esophagectomy. As arandomized control trial, the aim of our study was to assess the efficacy ofICG fluorescence angiography in the reduction of AL rates in minimally invasiveesophagectomy (MIE). Research Hypothesis being - Indocyanine green FluorescenceAngiography is a potentially promising method to assess gastric conduit’svascular perfusion during minimally invasive esophagectomy in real time, usefulfor deciding the site of anastomosis thereby decreasing the rate of anastomoticleakage compared to the conventional clinical method of deciding the site ofanastomosis. The research question being Does Fluorescent Imaging usingIndocyanine Green during Minimally Invasive Esophagectomy help decreasingSurgical Morbidity and changing the Surgical Plan? Aim: To study the effect ofadding Florescent Imaging using Indocyanine Green during MinimallyInvasive Surgery for Oesophageal Cancer on surgical morbidity andultimately, the surgical plan. Primary Objective: To evaluate the efficacyof ICG use in the intraoperative period in minimally invasive esophagectomy, indecreasing the anastomotic leak rates after esophagectomy. Secondary Objectives: Tostudy the use of ICG during minimally invasive esophagectomy in bringing abouta change in surgical planning. To evaluate the operative time, blood loss, timeuntil restoration of fluid diet, length of hospital stay, postoperativecomplications after the use of ICG fluorescence angiography during theintraoperative period of minimally invasive esophagectomy. To develop astandardized operative procedure of ICG use in oesophageal surgeries.Study design: Single centre, phase 2 randomizedcontrolled trial with allocation ratio of 1:1.  Inclusion criteria - Patients aged 18 years patients orolder. Histologically confirmed resectable primary squamous cellcarcinoma/adenocarcinoma of the oesophagus/GEJ candidates Exclusion criteria - Patients not willing for the participation in thepresent study. Patients with a previous history of lungcancer, severe comorbidities, distant metastasis, combined multivisceralresectionllergic hypersensitivity to ICG or iodine. Sample size:  Significancelevel- 0.05; Power- 90%, Allocation ratio- 1:1. Expected leak in the test group- 5% and Expected leak in the control group- 15%, - Sample Size in each armis 20 (total 40). Studyduration: The study shallbe conducted from August 2023 to November 2025. **Parameters:**Age,sex, BMI, comorbidities, history of smoking, history of drinking, AmericanSociety of Anaesthesiologists (ASA) grading, histopathology details, and tumourlocation. Pre-therapy staging workup, Upper gastrointestinal endoscopyfindings, information on preoperative therapies, including neoadjuvantradiotherapy (NRC), neoadjuvant chemotherapy (NAC), and  Operative parameters like the type of primarysurgery, technique (McKeown’s/Ivor-Lewis’), extent of Lymphadenectomy(Two/Three Field, duration of Surgery (hours), intraoperative blood loss(ml), fluid diet time (days), conventional anastomotic site from the pylorus(distance in cm), ICG Watershed (distance in cm from pylorus), ICGinduced anastomotic site revision (distance in cm from pylorus) anddifference between revision site and original site will be recorded. Postoperativeoutcomes and complications assessed up to 30 days after the index surgery. Secondary outcome parameters include operativetime, blood loss, time until restoration of fluid diet, length of hospital stayand postoperative complications other than an anastomotic leak.  EORTC Quality of Life Questionnaire forEsophago-gastric cancers. Timeline - Ethical approval and CTRI registration. Data collecting will be done in next one and half year.Data analysis will be done byNovember 2025