Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy

NCT05125653 | Completed

• 1 other identifier: AinShamsSurg2
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cholecystitis; Chronic Calculous Cholecystitis; Acute Calculous Cholecystitis

Keywords

Laparoscopic Cholecystectomy; Indocyanine Green Fluorescent Cholangiography; Indocyanine Green Fluorescent Angiography

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  during the procedure

Secondary Outcomes (5)

• Visual identification of injuries

  during and imediatly after the procedure (24 hours)

• Compare operative time

  during the procedure

• Compare blood loss

  during the procedure

• Compare blood loss in cc

  during the procedure

• Percentage of patients of ICG adverse reactions

  Within 24 hour of the procedure

Study Arms (2)

NIR/ICG Arm

EXPERIMENTAL

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

Procedure: Indocyanine Green Fluorescent Laparoscopic Cholangiography

WL Arm

ACTIVE COMPARATOR

Conventional white light was used for Laparoscopic Cholecystectomy

Procedure: White Light

Interventions

Indocyanine Green Fluorescent Laparoscopic Cholangiography PROCEDURE

Indocyanine Green Fluorescent Cholangiography

Also known as: Indocyanine Green Fluorescent LaparoscopicCholangiography

NIR/ICG Arm

White Light PROCEDURE

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

Also known as: WL

WL Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with history of previous biliary surgery
• Patients with abdominal malignancy
• Patients with advanced chronic liver disease
• pregnant women

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals - AUSH

Cairo, Egypt

Location

MeSH Terms

Conditions

Cholecystitis; Cholecystitis, Acute

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• M Abd-erRazik, MD

  Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of General Surgery

Model Details: 2 arms, randomized, double blinded

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: November 18, 2021
• Study Start: January 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: December 1, 2021

Record last verified: 2021-11

Locations

EG (1)