Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy

November 18, 2021 updated by: Mohammad Ahmad Abd-erRazik, Ain Shams University

Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy, a Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University Hospitals - AUSH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NIR/ICG Arm
Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography will be done during the Laparoscopic Cholecystectomy
Procedure: Indocyanine Green Fluorescent Laparoscopic Cholangiography
Indocyanine Green Fluorescent Cholangiography
Other Names:
  • Indocyanine Green Fluorescent LaparoscopicCholangiography
Active Comparator: WL Arm
Conventional white light was used for Laparoscopic Cholecystectomy
Procedure: White Light
Performing the laparoscopic cholecystectomy and identifying the biliary structures under the conventional white light
Other Names:
  • WL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual identification of the biliary tree
Time Frame: during 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.
during the procedure
Visual identification of the cystic artery
Time Frame: during the procedure
To measure the % of patients in which investigators can identify visually the cystic artery, during LC.
during the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual identification of injuries
Time Frame: during 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.
during and imediatly after the procedure (24 hours)
Compare operative time
Time Frame: during the procedure
To compare the operative time in (minutes)
during the procedure
Compare blood loss
Time Frame: during the procedure
To compare the operative blood loss (in cc)
during the procedure
Compare blood loss in cc
Time Frame: during the procedure
To compare the blood loss (in cc) between the two groups.
during the procedure
Percentage of patients of ICG adverse reactions
Time Frame: Within 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..)
Within 24 hour of the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Chair: M Abd-erRazik, MD, ain shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

October 4, 2021

First Submitted That Met QC Criteria

November 6, 2021

First Posted (Actual)

November 18, 2021

Study Record Updates

Last Update Posted (Actual)

December 1, 2021

Last Update Submitted That Met QC Criteria

November 18, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AinShamsSurg2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cholecystitis

Clinical Trials on Indocyanine Green Fluorescent Laparoscopic Cholangiography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe