MedPath

Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy

Not Applicable
Completed
Conditions
Acute Calculous Cholecystitis
Chronic Calculous Cholecystitis
Cholecystitis
Interventions
Procedure: Indocyanine Green Fluorescent Laparoscopic Cholangiography
Procedure: 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
Inclusion Criteria
  • 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.
Read More
Exclusion Criteria
  • Patients with history of previous biliary surgery
  • Patients with abdominal malignancy
  • Patients with advanced chronic liver disease
  • pregnant women
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
NIR/ICG ArmIndocyanine Green Fluorescent Laparoscopic CholangiographyIndocyanine Green Fluorescent Cholangiography and Intraoperative Angiography will be done during the Laparoscopic Cholecystectomy
WL ArmWhite LightConventional white light was used for Laparoscopic Cholecystectomy
Primary Outcome Measures
NameTimeMethod
Visual identification of the biliary treeduring 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 arteryduring the procedure

To measure the % of patients in which investigators can identify visually the cystic artery, during LC.

Secondary Outcome Measures
NameTimeMethod
Compare blood lossduring the procedure

To compare the operative blood loss (in cc)

Compare operative timeduring the procedure

To compare the operative time in (minutes)

Compare blood loss in ccduring the procedure

To compare the blood loss (in cc) between the two groups.

Visual identification of injuriesduring 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 reactionsWithin 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

© Copyright 2025. All Rights Reserved by MedPath