| 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
|
|
|
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
|
|
|
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
|