NCT05506020

Brief Summary

The purpose of this study was to assess the effects of indocyanine green (ICG) fluorescence cholangiography during laparoscopic left lateral sectionectomy (LLLS) on the occurrence of biliary complications in both donors and recipients in living donor liver transplantation (LDLT) and to explore the optimal dose and injection time of ICG.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

October 1, 2016

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

5.6 years

First QC Date

August 16, 2022

Last Update Submit

August 16, 2022

Conditions

Living Donor Liver Transplantation

Outcome Measures

Primary Outcomes (1)

  • Biliary complications

    bile leakage and biliary stenosis

    two months after operation

Study Arms (2)

ICG group

EXPERIMENTAL

indocyanine green (ICG) fluorescence cholangiography

Procedure: indocyanine green (ICG) fluorescence cholangiography

non ICG group

NO INTERVENTION

no intervention

Interventions

indocyanine green (ICG) fluorescence cholangiographyPROCEDURE

indocyanine green (ICG) fluorescence cholangiography during operation

ICG group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • From October 2016 to May 2022, donors and their corresponding recipients underwent laparoscopic donor liver acquisition surgery in the general surgery department of Huashan Hospital.
  • Donor age ≥ 18 years old, regardless of gender; The receptor is the corresponding receptor of the donor, and the age and sex of the receptor are unlimited.
  • The medical history is complete, which can meet the requirements of this study.
  • Volunteer to participate in this study.

You may not qualify if:

  • The medical history is incomplete, which cannot meet the requirements of this study.
  • The donor or recipient expressly refused to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Lunxiu Qin

    Department of general surgery, Huashan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the department of general surgery, Huashan Hospital

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 18, 2022

Study Start

October 1, 2016

Primary Completion

May 1, 2022

Study Completion

July 1, 2022

Last Updated

August 18, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share