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Completed

NCT Number: NCT05926856

High Quality Fluorescent Cholangiography

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Southern Medical University

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient has indications for cholecystectomy and requires laparoscopic treatment;
  • 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

  • Patients who require emergency surgical treatment;
  • Patients with malignant tumors of the biliary tract;
  • Patients with a history of abdominal surgery;
  • 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.

Treatment and study plan

Indocyanine green

Drug

Indocyanine Green 25mg kit for injection

Primary outcomes

  1. Common bile duct-to-liver fluorescence intensity ratio

    Time frame: Intraoperative (The beginning of the surgery)

    Common bile duct-to-liver fluorescence intensity ratio

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Registry information

Official study title

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

Acronym: HQFC

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 3, 2023
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.