| CTRI Number |
CTRI/2025/03/081592 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Indocyanine green dye and Metylene blue dye for
better visualisation of biliary tree structure in laparoscopic cholecystectomy . |
|
Scientific Title of Study
|
A Single-Blinded Randomized Control Trial in Utility of Visualization of Biliary Tract by Indocyanine Green versus Methylene Blue in Adult Patients undergoing Laparoscopic Cholecystectomy in a Tertiary Care Centre |
| 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 Venkatesh |
| Designation |
Junior Resident |
| Affiliation |
All India Institue of Medical Science ,Nagpur |
| Address |
Room no 202, OPD building, Department of General Surgery, All India Institute of Medical Sciences, Mihan, Dahegaon, Nagpur Nagpur MAHARASHTRA 441108 India
Nagpur
MAHARASHTRA
441108
India |
| Phone |
7406666462 |
| Fax |
|
| Email |
venkateshmurthy3285@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yeshwant Lamture |
| Designation |
Professor |
| Affiliation |
All India Institue of Medical Science ,Nagpur |
| Address |
Room no 202, OPD building, Department of General Surgery, All India Institute of Medical Sciences, Mihan, Dahegaon, Nagpur Nagpur MAHARASHTRA 441108 India
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9960371205 |
| Fax |
|
| Email |
yash18671@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yeshwant Lamture |
| Designation |
Professor |
| Affiliation |
All India Institue of Medical Science ,Nagpur |
| Address |
Room no 202, OPD building, Department of General Surgery, All India Institute of Medical Sciences, Mihan, Dahegaon, Nagpur Nagpur MAHARASHTRA 441108 India
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9960371205 |
| Fax |
|
| Email |
yash18671@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Dahegaon, MIHAN, Nagpur. PINCODE:441108 |
|
|
Primary Sponsor
|
| Name |
Dr Venkatesh |
| Address |
Room no 202, OPD building, Department of General Surgery, All India Institute of Medical Sciences, Mihan, Dahegaon, Nagpur Nagpur MAHARASHTRA 441108 India |
| 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 Venkatesh |
ALL INDIA INSTITUE OF MEDICAL SCIENCE ,NAGPUR |
Room no 202, OPD building, Department of General Surgery, All India Institute of Medical Sciences, Mihan, Dahegaon, Nagpur Nagpur MAHARASHTRA 441108 India
Nagpur
MAHARASHTRA |
7406666462
venkateshmurthy3285@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Department of Pharmacology, AIIMS Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Use of indocyanine green for visualisation of biliary tree in laparoscopic cholecystectomy |
one group will receive IV Indocyanine green for visualising biliary tree in laparoscopic cholecystectomy for
18 months . |
| Comparator Agent |
Use of Methylene Green for visualisation of biliary tree in laparoscopic cholecystectomy |
one group will receive transcholecystic Methylene blue for visualising biliary tree in laparoscopic cholecystectomy for
18 months . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged 18 years or older scheduled for laparoscopic cholecystectomy.
2.Diagnosis of symptomatic cholelithiasis requiring surgical intervention.
3.Ability to provide informed consent for participation in the study.
4.Adequate renal function, as determined by serum creatinine levels within normal range.
5.Ability to tolerate general anesthesia and laparoscopic surgery.
|
|
| ExclusionCriteria |
| Details |
1.Known allergy or contraindication to Indocyanine Green (ICG) or Methylene Blue (MB).
2.History of significant liver dysfunction or liver disease, including cirrhosis.
3.Pregnancy or breastfeeding status.
4.Presence of Ca gallbladder, severe cardiovascular disease, uncontrolled hypertension, or significant pulmonary disease
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study compares Indocyanine Green (ICG) and Methylene Blue (MB) in visualizing the biliary tract during laparoscopic cholecystectomy to enhance safety and reduce bile duct injury. ICG, with near-infrared fluorescence, is simple, feasible, and cost-effective, aiding in complex cases. MB, widely used in abdominal surgery, helps detect vital structures. By assessing both agents, this study aims to guide best practices for biliary tract identification during surgery. |
intraoperative monitoring ,
on day 1 ,3 ,5 and after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To estimate & compare the achievement of critical view of safety in Indocyanine green group & methylene blue group.
2. The estimate & compare the surgeon satisfaction score as per surgical rating scale in both group .
3.To estimate & compare Nassar grade in both group .
4.Correlation of Nassar grade with surgical rating scale in both group.
5.To estimate & compare operating time, intraoperative complication, conversion to open in both group .
|
intraoperative monitoring and
on day 1 & day 3 & day 5 & after 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
12/03/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This single blinded randmised control trial evaluates the utility of indocyanine green (ICG) and methylene blue (MB) in enhancing biliary tract visualization during laparoscopic cholecystectomy in adult patients at a tertiary care center the study aims to determine which agent provides better visualization of critical biliary structures such as cystic duct and common bile duct to minimize bile duct injuries and improve surgical safety . ICG , administered pre operatively , utilizes near infrared fluorescence imaging for real time visulization , while MB , injected intra operatively , stains the biliary anatomy directly for immediate identification . by comparing these agents , the study seeks to optimize surgical techniques and enhance patient outcomes in routine clinical practice |