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Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy

A

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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