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CTRI Number  CTRI/2023/09/058118 [Registered on: 29/09/2023] Trial Registered Prospectively
Last Modified On: 28/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study of the utility of Indocyanine Green Fluorescent Dye in Reducing Postoperative Complications in Minimally Invasive Surgery for Oesophageal Cancer 
Scientific Title of Study   Effect of Fluorescent Imaging using Indocyanine Green on Surgical Morbidity during Minimally Invasive Surgery for Oesophageal Cancer (IndoCinMIE): A Phase2 Randomized Controlled Trial 
Trial Acronym  IndoCinMIE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aashish Kamatham 
Designation  Senior Resident 
Affiliation  AIl India Institute of Medical Sciences, Jodhpur 
Address  All India Institute of Medical Sciences, Department of Surgical Oncology, OPD No - 510 (5th Floor - A Block) Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Jodhpur, Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone    
Fax    
Email  aashishkamatham@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jeewan Ram Vishnoi 
Designation  Additional Professor and Head of Department  
Affiliation  AIl India Institute of Medical Sciences, Jodhpur 
Address  Department of Surgical Oncology, All India Institute of Medical Sciences, Marudhar Industrial Area, 2nd Phase, Basni, Jodhpur.

Jodhpur
RAJASTHAN
342005
India 
Phone  9455061569  
Fax    
Email  drjvishnoi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Aashish Kamatham 
Designation  Senior Resident 
Affiliation  AIl India Institute of Medical Sciences, Jodhpur 
Address  All India Institute of Medical Sciences Department of Surgical Oncology, OPD No - 510 (5th Floor - A Block) Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Jodhpur, Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone    
Fax    
Email  aashishkamatham@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Jodhpur 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Jodhpur 
Address  Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aashish Kamatham  All India Institute of Medical Sciences  Department of Surgical Oncology, OPD No - 510 (5th Floor - A Block) Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN 
9945118244

aashishkamatham@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute of Medical Sciences, Jodhpur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C159||Malignant neoplasm of esophagus, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ICG  In the ICG-Group, Intraoperatively, during minimally invasive esophagectomy, the surgeons will check the conditions of the gastric conduit fashioned, such as the colour of the gastric serosa, arterial pulsation of the gastroepiploic artery, and the connection between the right and left gastroepiploic vessels and a site for anastomosis is marked as per conventional clinical sense. For patients in the ICG group, 0.5 mg/kg or a maximum of 25 mg of ICG dye will be diluted in 10 cc of sterile water, and will be injected as a bolus through a central venous catheter by assistant. A near-infrared camera system will be used for detecting the ICG fluorescence. Evaluation with fluorescence was performed in real-time. Approximately 20 s after injection, blood flow will be confirmed by ICG as it passed through the right gastroepiploic vessels. If vascular perfusion via ICG-FA is well visualized within 60 s, it is defined as a good perfusion zone, while no vascular perfusion or perfusion times 60 s will indicate a poor perfusion zone. The anastomotic perfusion result using ICG-FA will be subjectively evaluated by the surgical team and the anastomosis will be performed within the good perfusion zone. The site of anastomosis decided by the conventional clinical sense would be marked and the distance from this point and the point of anastomosis decided after the use of ICG would be measured and the difference noted i.e., change in surgical planning as far as the site of anastomosis of the gastric conduit and remnant oesophagus (oesophago-gastric anastomosis).  
Comparator Agent  Non-ICG   In Non-ICG Group, during minimally invasive esophagectomy, the surgeons will check the conditions of the gastric conduit fashioned, such as the colour of the gastric serosa, arterial pulsation of the gastroepiploic artery, and the connection between the right and left gastroepiploic vessels and a site for anastomosis is marked as per conventional clinical sense and the oesophago-gastric anastomosis is made as per this.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Histologically confirmed resectable primary squamous cell carcinoma/adenocarcinoma of the oesophagus/GEJ candidates.
2. ECOG PS 0-2 fit to undergo radical surgery.
3. Patients with an informed consent to be included in the study.
 
 
ExclusionCriteria 
Details  1. Patients who have undergone prior surgery for Oesophageal cancer.
2. Patients with a previous history of gastrointestinal or lung cancer, severe comorbidities, other organ distant metastasis, combined other organ resection.
3. Allergic hypersensitivity to ICG or iodine.
4. Patients not providing informed consent to participate in the study
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Indocyanine Green Dye use in the intraoperative period in minimally invasive esophagectomy, in decreasing the anastomotic leak rates after esophagectomy.   1 week & 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To study the use of ICG during minimally invasive esophagectomy in bringing about a change in surgical planning.  at baseline 
To evaluate the operative time, blood loss, time until restoration of fluid diet, length of hospital stay, postoperative complications after the use of ICG fluorescence angiography during the intraoperative period of minimally invasive esophagectomy.   7 days 
To develop a standardized operative procedure of ICG use in oesophageal surgeries.  on trial conclusion 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   06/10/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Esophagectomy is still the mainstream multidisciplinary treatment for esophageal cancer in combination with chemoradiotherapy. Anastomotic leakage (AL) after esophagectomy is one of the most dreaded postoperative complications, and is responsible for higher postoperative morbidity and mortality rates, prolonged hospital stays, and the need for further surgical procedures. Anastomotic tension, location of anastomosis, surgical technique, and postoperative factors, are modifiable factors when AL is concerned, and many efforts have been made to decrease AL in the last decades. Vascular perfusion to the anastomotic regions is considered to be the main driving force of AL. As a means of evaluating blood flow, indocyanine green (ICG) fluorescence angiography (FA) has recently been introduced to provide real-time assessment of the anastomosis area during esophagectomy. As a randomized control trial, the aim of our study was to assess the efficacy of ICG fluorescence angiography in the reduction of AL rates in minimally invasive esophagectomy (MIE). Research Hypothesis being - Indocyanine green Fluorescence Angiography is a potentially promising method to assess gastric conduit’s vascular perfusion during minimally invasive esophagectomy in real time, useful for deciding the site of anastomosis thereby decreasing the rate of anastomotic leakage compared to the conventional clinical method of deciding the site of anastomosis. The research question being Does Fluorescent Imaging using Indocyanine Green during Minimally Invasive Esophagectomy help decreasing Surgical Morbidity and changing the Surgical Plan? Aim: To study the effect of adding Florescent Imaging using Indocyanine Green during Minimally Invasive Surgery for Oesophageal Cancer on surgical morbidity and ultimately, the surgical plan. Primary Objective: To evaluate the efficacy of ICG use in the intraoperative period in minimally invasive esophagectomy, in decreasing the anastomotic leak rates after esophagectomy. Secondary Objectives: To study the use of ICG during minimally invasive esophagectomy in bringing about a change in surgical planning. To evaluate the operative time, blood loss, time until restoration of fluid diet, length of hospital stay, postoperative complications after the use of ICG fluorescence angiography during the intraoperative period of minimally invasive esophagectomy. To develop a standardized operative procedure of ICG use in oesophageal surgeries. Study design: Single centre, phase 2 randomized controlled trial with allocation ratio of 1:1.  Inclusion criteria - Patients aged 18 years patients or older. Histologically confirmed resectable primary squamous cell carcinoma/adenocarcinoma of the oesophagus/GEJ candidates Exclusion criteria - Patients not willing for the participation in the present study. Patients with a previous history of lung cancer, severe comorbidities, distant metastasis, combined multivisceral resectionllergic hypersensitivity to ICG or iodine. Sample size:  Significance level- 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 arm is 20 (total 40). Study duration: The study shall be conducted from August 2023 to November 2025. Parameters: Age, sex, BMI, comorbidities, history of smoking, history of drinking, American Society of Anaesthesiologists (ASA) grading, histopathology details, and tumour location. Pre-therapy staging workup, Upper gastrointestinal endoscopy findings, information on preoperative therapies, including neoadjuvant radiotherapy (NRC), neoadjuvant chemotherapy (NAC), and  Operative parameters like the type of primary surgery, 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), ICG induced anastomotic site revision (distance in cm from pylorus) and difference between revision site and original site will be recorded. Postoperative outcomes and complications assessed up to 30 days after the index surgery.  Secondary outcome parameters include operative time, blood loss, time until restoration of fluid diet, length of hospital stay and postoperative complications other than an anastomotic leak.  EORTC Quality of Life Questionnaire for Esophago-gastric cancers. Timeline - Ethical approval and CTRI registration. Data collecting will be done in next one and half year. Data analysis will be done by November 2025

 

 
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