High Quality Fluorescent Cholangiography (HQFC)

December 11, 2023 updated by: Chihua Fang,MD, Zhujiang Hospital

Comparison of the Fluorescent Visualization of the Extrahepatic Biliary Tract Between Two Injection Protocols

The goal of this randomized controlled trial is to compare the quality of extrahepatic biliary fluorescent visualization under two injection protocols to optimize extrahepatic biliary cholangiography.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Biliary fluorescence imaging is widely used to identify the extrahepatic biliary tract during laparoscopic cholecystectomy. However, fluorescent developer Indocyanine Green（ICG） still lacks standardization, and not every visualization of the extrahepatic biliary tract is satisfactory. Some research groups have shown that injection of ICG 1 day before surgery can achieve the best fluorescence imaging of the biliary tract, but some research groups have suggested that injection of a very low dose of ICG 45 minutes before surgery can improve the satisfaction of fluorescence imaging. However, no study compares the quality of biliary fluorescence imaging between the two injection protocols. This study will compare the fluorescence imaging effects of the two schemes to obtain the best injection scheme at present and standardize the use of icg.

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Phase 2
  • Phase 3

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

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Southern Medical University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The patient has indications for cholecystectomy and requires laparoscopic treatment；
  2. No biliary obstruction or cholestasis was found during preoperative examination；3.Volunteer to participate in this clinical trial and sign written informed consent.

Exclusion Criteria:

  1. Patients who require emergency surgical treatment；
  2. Patients with malignant tumors of the biliary tract；
  3. Patients with a history of abdominal surgery；
  4. Patients who are allergic to indocyanine green or iodine contrast agents；5.Patients participating in one or more other clinical trials simultaneously；

6.Patients who have received medication that affects bile excretion within 2 weeks before surgery； 7.Other situations that have been judged unsuitable for inclusion by researchers.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1 day before surgery
0.25mg/kg Indocyanine Green will be administered 1 day before surgery
Drug: Indocyanine green
Indocyanine Green 25mg kit for injection
Experimental: 45 min before surgery
0.05mg Indocyanine Green will be administered 45minutes before surgery
Drug: Indocyanine green
Indocyanine Green 25mg kit for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Common bile duct-to-liver fluorescence intensity ratio
Time Frame: Intraoperative (The beginning of the surgery)
Common bile duct-to-liver fluorescence intensity ratio
Intraoperative (The beginning of the surgery)

Collaborators and Investigators

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

Sponsor

Zhujiang Hospital

Investigators

  • Principal Investigator: Jian Yang, MD, Zhujiang Hospital

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)

August 4, 2023

Primary Completion (Actual)

December 11, 2023

Study Completion (Actual)

December 11, 2023

Study Registration Dates

First Submitted

June 2, 2023

First Submitted That Met QC Criteria

June 29, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Estimated)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20230420

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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