| CTRI Number |
CTRI/2025/02/079963 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
15/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Studying the optimal dosage and timing of intervention (Indocyanin Green administration) in participants undergoing Laparoscopic Cholecystectomy. |
|
Scientific Title of Study
|
Optimization of Indocyanin Green (ICG) Administration for Enhanced Visualization of Extrahepatic Biliary System during Laparoscopic Cholecystectomy - A Pilot Randomized Control Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krishna Kalyan Reddy Janumpalli |
| Designation |
DrNB Resident - Surgical Gastroenterology |
| Affiliation |
National Institute of Gastroenterology and Liver Diseases |
| Address |
Ground floor, NIGL Hospital, Road No 12, Banjara Hills, Hyderabad
Hyderabad TELANGANA 500034 India |
| Phone |
8105135208 |
| Fax |
|
| Email |
kalyanreddy@outlook.com |
|
Details of Contact Person Scientific Query
|
| Name |
R.V. Raghavendra Rao |
| Designation |
Surgical Gastroenterologist and Liver Transplant Surgeon |
| Affiliation |
National Institute of Gastroenterology and Liver Diseases |
| Address |
NIGL Hospital, Plot No 344A, MLA Colony, Road No 12, Banjara Hills, Hyderabad
Hyderabad TELANGANA 500034 India |
| Phone |
7993089995 |
| Fax |
|
| Email |
dnb.bh@renovahospitals.com |
|
Details of Contact Person Public Query
|
| Name |
Krishna Kalyan Reddy Janumpalli |
| Designation |
DrNB Resident - Surgical Gastroenterology |
| Affiliation |
National Institute of Gastroenterology and Liver Diseases |
| Address |
Groud Floor, NIGL Hospital, Road No 12, Banjara Hills, Hyderabad
TELANGANA 500034 India |
| Phone |
8105135208 |
| Fax |
|
| Email |
kalyanreddy@outlook.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Gastroenterology and Liver Diseases, Road No.12, Banjara Hills, Hyderabad -500034, Telangana, India |
|
|
Primary Sponsor
|
| Name |
Department of Surgical Gastroenterology |
| Address |
National Institute of Gastroenterology and Liver Diseases, Road No. 12, Banjara Hills, Hyderabad-500034, Telangana, India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Krishna Kalyan Reddy Janumpalli |
Department of Surgical Gastroenterology, National Institute of Gastroenterology and Liver Diseases |
Ground Floor, Department of Surgical Gastroenterology Hyderabad TELANGANA |
8105135208
kalyanreddy@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee-Prime Hospital |
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: K802||Calculus of gallbladder without cholecystitis, (3) ICD-10 Condition: K805||Calculus of bile duct without cholangitis or cholecystitis, (4) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, (5) ICD-10 Condition: K807||Calculus of gallbladder and bile duct without cholecystitis, (6) ICD-10 Condition: K851||Biliary acute pancreatitis, (7) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Administration of 10 mg Indocyanin Green (ICG) at 4-6 hrs before surgery |
10 mg of Indocyanin Green (ICG) is injected at the specified time before surgery |
| Intervention |
Administration of 2.5 mg Indocyanin Green (ICG) at 1hr before surgery |
2.5 mg of Indocyanin Green (ICG) is injected at the specified time before surgery |
| Comparator Agent |
Administration of 25 mg Indocyanin Green (ICG) at 10-12 hrs before surgery |
25 mg of Indocyanin Green (ICG) is injected at the specified time before surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing Laparoscopic Cholecystectomy will be given a choice to participate in the study |
|
| ExclusionCriteria |
| Details |
Age more than 80 years
Age less than 18 years
Patients with Acute Cholecystitis
Patients with Iodine Allergy
Patients with allergy to test dose of Indocyanin Green (ICG)
Patients with Chronic Liver Disease
Patients on Chemotherapy
Patients with Hyperthyroid
Patients with Obesity |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare effectiveness of preoperative ICG administration at 1 hr, 4-6hrs and 10-12 hrs prior to surgery to enhance intraoperative visualization of etrahepatic bile ducts |
Outcome will be assessed intraoperatively during surgical procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visulaisation quality in 1 hr group, 4-6 hrs group & 10-12 hrs group |
Outcome will be assessed intraoperatively during surgical procedure. |
| Identification of critical structures in the groups |
Outcome will be assessed intraoperatively during surgical procedure. |
|
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/02/2025 |
| Date of Study Completion (India) |
15/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="10" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Due for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Laparoscopic cholecystectomy is a minimally invasive surgical procedure used to remove the gallbladder, typically due to gallstones or other gallbladder diseases. However, one potential complication of the procedure is bile duct injury (BDI), which occurs when the bile duct is accidentally cut, clipped, or otherwise damaged during the procedure. Reported incidence of BDI varies between 0.2% to 0.7% but it can lead to serious complications such as bile leakage, infection, biliary peritonitis and even long-term health problems if not promptly identified and treated in addition to increased hospital stay and need for further interventions. Intraoperative cholangiography has been a traditional method used to visualize the bile duct anatomy during cholecystectomy but it involves injecting contrast dye into the bile duct and taking X-ray images to identify any abnormalities or injuries. It requires special expertise in technique and its interpretation, additional equipment, radiation exposure, and prolongs the surgical procedure. An emerging alternative to Intraoperative cholangiography is the use of indocyanine green (ICG) fluorescence imaging. ICG is a fluorescent dye that can be injected intravenously and visualized using specialized imaging systems during surgery. By selectively highlighting the bile duct and surrounding structures, ICG fluorescence imaging allows surgeons to better identify and avoid injuring the bile duct during LC. However, the timing of ICG administration plays a crucial role in adequate fluorescence of the extra hepatic bile ducts. The reason for this being background fluorescence from liver distorting the perception of bile ducts. If fluorescence imaging is performed immediately after the administration of ICG, the liver will be highly fluorescent while bile ducts will not yet contain enough ICG. On the other hand, if fluorescence imaging is performed too long after the administration of ICG, the fluorescence intensity of the common bile duct (CBD) and liver will be so low that it wouldn’t be conducive to identifying anatomical structures. Hence in this context, the study being conducted to assess the optimal timing of ICG administration before Laparoscopic Cholecystectomy to enhance the visualization of extra hepatic bile ducts during surgery. |