Impact of Indocyanine Green Fluorescence on Surgical Precision in Difficult Cholecystectomy - A Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Operative time from insertion of ports to achieving critical view of safety (CVS).
Study Overview
Brief Summary
Surgical anatomy is difficult to visualised frequently in difficult cholecystectomies , therefore number of patients with CBD injury is higher than regular cholecystectomies hence there is a need to support the process of identification of anatomy to visualise the critical view of safety. Additionally intraoperative fluorescence imaging with ICG was recently shown to be an alternative to intraoperative cholangiography for visualizing the extrahepatic biliary structures during laparoscopic cholecystectomy ( LC).Surgical anatomy is difficult to visualised frequently in difficult cholecystectomies , therefore number of patients with CBD injury is higher than regular cholecystectomies hence there is a need to support the process of identification of anatomy to visualise the critical view of safety. Additionally intraoperative fluorescence imaging with ICG was recently shown to be an alternative to intraoperative cholangiography for visualizing the extrahepatic biliary structures during laparoscopic cholecystectomy ( LC).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1 Age ≥ 18 years 2 Gall stone disease patients with moderate and high risk of difficult cholecystectomy on preoperative risk assessment scale 3 Hemodynamically stable 4 Fit for General anaesthesia • Laparoscopic cholecystectomy indicated either interval or immediate( within 72 hrs of presentation).
Exclusion Criteria
- •1 Allergy to Indocyanine green (ICG) 2 Patients with low risk of difficult cholecystectomy on preoperative risk assessment scale 3 Patient for which consent could not be obtained.
Outcomes
Primary Outcomes
Operative time from insertion of ports to achieving critical view of safety (CVS).
Time Frame: once on operation table
Secondary Outcomes
- blood loss(once on operation table)
- Bile duct injury(once on operation table)
- Conversion to open(once on operation table)
- Post operative bile leak(once on operation table)
- Hospital stay(once on operation table)
Investigators
Dr Anita Dhar
ALL INDIA INSTITUTE OF MEDICAL SCIENCES