Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy

NCT ID: NCT05125653

Last Updated: 2021-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cholecystitis Chronic Calculous Cholecystitis Acute Calculous Cholecystitis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Laparoscopic Cholecystectomy Indocyanine Green Fluorescent Cholangiography Indocyanine Green Fluorescent Angiography

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 arms, randomized, double blinded
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NIR/ICG Arm

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

Group Type EXPERIMENTAL

Indocyanine Green Fluorescent Laparoscopic Cholangiography

Intervention Type PROCEDURE

Indocyanine Green Fluorescent Cholangiography

WL Arm

Conventional white light was used for Laparoscopic Cholecystectomy

Group Type ACTIVE_COMPARATOR

White Light

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Indocyanine Green Fluorescent Laparoscopic Cholangiography

Indocyanine Green Fluorescent Cholangiography

Intervention Type PROCEDURE

White Light

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

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Indocyanine Green Fluorescent LaparoscopicCholangiography WL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohammad Ahmad Abd-erRazik

Lecturer of General Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

M Abd-erRazik, MD

Role: STUDY_CHAIR

Ain Shams University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ain Shams University Hospitals - AUSH

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AinShamsSurg2

Identifier Type: -

Identifier Source: org_study_id