Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy

Ain Shams University118 enrolled

Overview

This was a double blinded, randomized, controlled trial involved patients underwent laparoscopic cholecystectomy

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

118

Conditions

Cholecystitis Chronic Calculous Cholecystitis Acute Calculous Cholecystitis

Interventions

Indocyanine Green Fluorescent Laparoscopic CholangiographyPROCEDURE

Indocyanine Green Fluorescent Cholangiography

White LightPROCEDURE

Performing the laparoscopic cholecystectomy and identifying the biliary structures under the conventional white light

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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. Exclusion Criteria: * Patients with history of previous biliary surgery * Patients with abdominal malignancy * Patients with advanced chronic liver disease * pregnant women

Locations (1)

Ain Shams University Hospitals - AUSH

Cairo, Egypt

Outcomes

Primary Outcomes

Visual identification of the biliary tree

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.

Time frame: during the procedure

Visual identification of the cystic artery

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

Time frame: during the procedure

Secondary Outcomes

Visual identification of injuries

To detect of incidence rate of biliary or vascular injury, visually or clinically, resulted from miss identification of the structures.

Time frame: during and imediatly after the procedure (24 hours)

Compare operative time

To compare the operative time in (minutes)

Time frame: during the procedure

Compare blood loss

To compare the operative blood loss (in cc)

Time frame: during the procedure

Compare blood loss in cc

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

Time frame: during the procedure

Percentage of patients of ICG adverse reactions

To measure % of patients suffering off reactions related to the use of ICG (by vital data assessment, monitor patients' complaints, etc..)

Time frame: Within 24 hour of the procedure

Data from ClinicalTrials.gov

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