| CTRI Number |
CTRI/2025/02/079963 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/02/2025 |
| 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)= "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)
|
15/02/2025 |
| 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="0" Months="10" 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
|
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. |