Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy
- Conditions
- Acute Calculous CholecystitisChronic Calculous CholecystitisCholecystitis
- Interventions
- Procedure: Indocyanine Green Fluorescent Laparoscopic CholangiographyProcedure: White Light
- Registration Number
- NCT05125653
- Lead Sponsor
- Ain Shams University
- Brief Summary
This was a double blinded, randomized, controlled trial involved patients underwent laparoscopic cholecystectomy
- Detailed Description
A double blinded, randomized, controlled trial involved patients underwent laparoscopic cholecystectomy in Ain-Shams University Specialized Hospital in the period from January 2020 till July 2021. Group A (n=60) underwent laparoscopic cholecystectomy using the usual white light, Group B (n=58) underwent laparoscopic cholecystectomy with ICG florescence cholangiography and intraoperative ICG florescence arteriography.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 118
- adults (from 18 to 75 years old)
- suffering from a gall bladder disease
- with valid indication for laparoscopic cholecystectomy (e.g., calculus gall bladder with cholecystitis)
- accepted to participate in the study.
- Patients with history of previous biliary surgery
- Patients with abdominal malignancy
- Patients with advanced chronic liver disease
- pregnant women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NIR/ICG Arm Indocyanine Green Fluorescent Laparoscopic Cholangiography Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography will be done during the Laparoscopic Cholecystectomy WL Arm White Light Conventional white light was used for Laparoscopic Cholecystectomy
- Primary Outcome Measures
Name Time Method Visual identification of the biliary tree during the procedure To measure the % of patients in which investigators can identify visually the extra hepatic biliary system (the CD, CBD, CHD, and any possible anomalies present), during LC.
Visual identification of the cystic artery during the procedure To measure the % of patients in which investigators can identify visually the cystic artery, during LC.
- Secondary Outcome Measures
Name Time Method Compare blood loss during the procedure To compare the operative blood loss (in cc)
Compare operative time during the procedure To compare the operative time in (minutes)
Compare blood loss in cc during the procedure To compare the blood loss (in cc) between the two groups.
Visual identification of injuries during and imediatly after the procedure (24 hours) To detect of incidence rate of biliary or vascular injury, visually or clinically, resulted from miss identification of the structures.
Percentage of patients of ICG adverse reactions Within 24 hour of the procedure To measure % of patients suffering off reactions related to the use of ICG (by vital data assessment, monitor patients' complaints, etc..)
Trial Locations
- Locations (1)
Ain Shams University Hospitals - AUSH
🇪🇬Cairo, Egypt