NCT05926856

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

August 4, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2023

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

June 2, 2023

Last Update Submit

December 11, 2023

Conditions

Extrahepatic Biliary Tree Injury

Keywords

icgfluorescent cholangiograph

Outcome Measures

Primary Outcomes (1)

  • Common bile duct-to-liver fluorescence intensity ratio

    Common bile duct-to-liver fluorescence intensity ratio

    Intraoperative (The beginning of the surgery)

Study Arms (2)

1 day before surgery

ACTIVE COMPARATOR

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

Drug: Indocyanine green

45 min before surgery

EXPERIMENTAL

0.05mg Indocyanine Green will be administered 45minutes before surgery

Drug: Indocyanine green

Interventions

Indocyanine greenDRUG

Indocyanine Green 25mg kit for injection

1 day before surgery45 min before surgery

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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；

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Medical University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jian Yang, MD

    Zhujiang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 2, 2023

First Posted

July 3, 2023

Study Start

August 4, 2023

Primary Completion

December 11, 2023

Study Completion

December 11, 2023

Last Updated

December 18, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)