| CTRI Number |
CTRI/2025/06/088526 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
08/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A THREE-GROUP RANDOMISED STUDY COMPARING: INJECTING ICG DYE INTO A VEIN, INSTILLING ICG DYE INTO THE GALLBLADDER, AND WITHOUT USING ICG DYE — COMPARING WHICH IS BETTER IN IDENTIFYING IMPORTANT STRUCTURES DURING MINIMALLY INVASIVE GALLBLADDER REMOVAL SURGERY |
|
Scientific Title of Study
|
THREE ARM RANDOMIZED TRIAL COMPARING INTRAVENOUS
INDOCYANINE GREEN, INTRA GALL BLADDER INDOCYANINE
GREEN AND NO INDOCYANINE GREEN DURING LAPAROSCOPIC
CHOLECYSTECTOMY IN ACHIEVING CRITICAL VIEW OF SAFETY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Asuri Krishna |
| Designation |
Additional Professor |
| Affiliation |
All india institute of medical sciences, New delhi |
| Address |
Room no-406 4th Floor Surgery Block Aiims New Delhi Pin-110049
South West DELHI 110049 India
New Delhi
DELHI
110049
India
South West
DELHI
-110049
India |
| Phone |
9051742097 |
| Fax |
|
| Email |
dr.asurikrishna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asuri Krishna |
| Designation |
Additional Professor |
| Affiliation |
All india institute of medical sciences, New delhi |
| Address |
Room no-406 4th Floor Surgery Block Aiims New Delhi Pin-110049
South West DELHI 110049 India
New Delhi
DELHI
110049
India
South West
DELHI
-110049
India |
| Phone |
9051742097 |
| Fax |
|
| Email |
dr.asurikrishna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nipun Chandra |
| Designation |
MS General Surgery |
| Affiliation |
All india institute of medical sciences, New delhi |
| Address |
Room no-406 4th Floor Surgery Block Aiims New Delhi Pin-110049
South West DELHI 110049 India
New Delhi
DELHI
110049
India
South West
DELHI
110049
India |
| Phone |
9937157927 |
| Fax |
|
| Email |
nipunchandra217@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Asuri Krishna |
| Address |
Room no - 406, 4th floor Surgery block AIIMS New Delhi Pin -
110049
|
| Type of Sponsor |
Other [Self] |
|
|
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 Asuri Krishna |
AIIMS New Delhi |
Room 406 4th floor Surgery Block AIIMS New Delhi Pin 110049
South West
DELHI |
9999405767
drasurikirshna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of ethics committee AIIMS ot block Ansari Nagar New Delhi 29 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (3) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Convetional laparoscopic assisted cholecystectomy |
Under GA, patient in reverse trendelenberg position with right side up , under all aseptic precautions parts painted and draped. Pneumoperitoneum created using open method via Supraumbilical incision and 12 mm port inserted. Other Standard ports placed under vision. Intraoperative finding noted . Calots identified and omental adhesions released . Calots dissection done to achieve Critical view of safety. Cystic artery and duct clipped with green hem o lock and golden hem o lock respectively and divided. Gall bladder dissected off its bed. Specimen retrieved through epigastric port. Warm saline wash given. Hemostasis ensured. Pneumodesufflated. Ports removed under vision. Supraumbilical port closed with port vicryl. Skin closure done with Nylon 3-0. Aseptic Dressing done.
|
| Intervention |
Laparoscopic assisted cholecystectomy with intra gall bladder ICG |
Under GA, patient in reverse trendelenberg position with right side up , under all aseptic precautions parts painted and draped. Pneumoperitoneum created using open method via Supraumbilical incision and 12 mm port inserted. Other Standard ports placed under vision. Intra gall bladder ICG given. Intraoperative finding noted . Calots identified and omental adhesions released . Calots dissection done to achieve Critical view of safety. Cystic artery and duct clipped with green hem o lock and golden hem o lock respectively and divided. Gall bladder dissected off its bed. Specimen retrieved through epigastric port. Warm saline wash given. Hemostasis ensured. Pneumodesufflated. Ports removed under vision. Supraumbilical port closed with port vicryl. Skin closure done with Nylon 3-0. Aseptic Dressing done. |
| Intervention |
Laparoscopic assisted cholecystectomy with intravenous ICG |
Under GA, patient in reverse trendelenberg position with right side up , under all aseptic precautions parts painted and draped. 1 ml of ICG(2.5mg/ml) will be injected intravenously. Pneumoperitoneum created using open method via Supraumbilical incision and 12 mm port inserted. Other Standard ports placed under vision. Intraoperative finding noted . Calots identified and omental adhesions released . Calots dissection done to achieve Critical view of safety. Cystic artery and duct clipped with green hem o lock and golden hem o lock respectively and divided. Gall bladder dissected off its bed. Specimen retrieved through epigastric port. Warm saline wash given. Hemostasis ensured. Pneumodesufflated. Ports removed under vision. Supraumbilical port closed with port vicryl. Skin closure done with Nylon 3-0. Aseptic Dressing done. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients with Ultrasound whole abdomen proved Gall stone disease who are hemodynamically stable
and fit for General anaesthesia in whom Laparoscopic cholecystectomy is indicated either interval or immediate( within
72 hrs of presentation). |
|
| ExclusionCriteria |
| Details |
Patients who are planned for simultaneous common bile duct (CBD) exploration or have undergone previous failed Endoscopic retrograde cholangiopancreatography (ERCP)
or have allergy to Indocyanine green (ICG) |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Operative time from insertion of ports to achieving critical view of safety. |
Operative time from insertion of ports to achieving critical view of safety. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood loss |
Intraoperatively |
| Conversion to Subtotal cholecystectomy |
Intraoperatively |
| Conversion to open cholecystectomy |
Intraoperatively |
| Bile duct injury |
Intraoperatively and in postoperative hospital stay |
| Post operative bile leak |
Postoperative hospital stay |
| Hospital stay |
Hospital stay |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
19/06/2025 |
| 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
|
Laparoscopic cholecystectomy has long been the first-line therapy for cholecystitis.
Various studies have clarified the predictive factors for surgical difficulties and indications
for conversion to laparotomy during Laparoscopic Cholecystectomy for cholecystitis. These
indications include iatrogenic bile duct injury , severe fibrosis, and scarring in Calot’s
triangle area or the gallbladder bed due to inflammation and bleeding. The critical view of
safety technique is the standard approach to avoid iatrogenic
Bile duct injury in Laparoscopic Cholecystectomy. Intraoperative fluorescence imaging with Indo Cyanine Green(ICG) was recently shown to be an alternative to intraoperative cholangiography for visualizing
the extrahepatic biliary structures during laparoscopic cholecystectomy. Bile duct injury is the most feared complication during laparoscopic cholecystectomy.
Real-time intraoperative imaging using indocyanine green (ICG) will reduce the risk of bile
duct injury by improving visualization of the biliary tree during laparoscopy. This effect will
also shorten operative time, reducing the dangers of prolonged operation time
The primary objective of this study is to conduct a comparative analysis of operative time taken from insertion of ports to achieving critical view of safety
(CVS) in conventional laparoscopic cholecystectomy, laparoscopic cholecystectomy with intravenous ICG for intraoperative fluorescence imaging and intra gall baldder ICG for intraoperative fluoresence imaging. Other parameters to be compared are intraoperative blood loss, coversion to open cholecystectomy, conversion to sub total cholecystectomy, bile duct injury, post operative bile leak and hospital stay.
Previous randomised controlled trials comparing comparing conventional laparoscopic cholecystectomy with laparoscopic cholecystectomy with intravenous/intra gall bladder ICG have shown shorter operative time and reduced intraoperative blood loss. But previous trials have limited comparative data of the three groups compared together and the difference in postoperative hospital morbidity.
The purpose of the present study is to compare the operative time taken from insertion of ports to achieving critical view of safety between the three groups- conventional laparoscopic cholecystectomy, laparoscopic cholecystectomy with intravenous ICG and laparoscopic cholecystecomy with intra gall bladder ICG |