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High Quality Fluorescent Cholangiography

NCT ID: NCT05926856

Last Updated: 2023-12-18

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-04

Study Completion Date

2023-12-11

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Extrahepatic Biliary Tree Injury

Keywords

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icg fluorescent cholangiograph

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1 day before surgery

0.25mg/kg Indocyanine Green will be administered 1 day before surgery

Group Type ACTIVE_COMPARATOR

Indocyanine green

Intervention Type DRUG

Indocyanine Green 25mg kit for injection

45 min before surgery

0.05mg Indocyanine Green will be administered 45minutes before surgery

Group Type EXPERIMENTAL

Indocyanine green

Intervention Type DRUG

Indocyanine Green 25mg kit for injection

Interventions

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Indocyanine green

Indocyanine Green 25mg kit for injection

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhujiang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chihua Fang,MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jian Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Zhujiang Hospital

Locations

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Southern Medical University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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20230420

Identifier Type: -

Identifier Source: org_study_id