Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy

Ain Shams University

Status: Completed

Conditions: Cholecystitis; Acute Calculous Cholecystitis; Chronic Calculous Cholecystitis

Treatments: Procedure: Indocyanine Green Fluorescent Laparoscopic Cholangiography; Procedure: White Light

Study type: Interventional

Funder types: Other

Identifiers

NCT05125653

AinShamsSurg2

Details and patient eligibility

About

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

Full 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.

Enrollment: 118 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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118 participants in 2 patient groups

NIR/ICG Arm

Experimental group

Description:

Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography will be done during the Laparoscopic Cholecystectomy

Treatment:

Procedure: Indocyanine Green Fluorescent Laparoscopic Cholangiography

WL Arm

Active Comparator group

Description:

Conventional white light was used for Laparoscopic Cholecystectomy

Treatment:

Procedure: White Light