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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05506020
Other study ID # Huashan009
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2016
Est. completion date July 2022

Study information

Verified date August 2022
Source Fudan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This was a retrospective cohort study. The purpose of this study was to assess the effects of indocyanine green (ICG) fluorescence cholangiography during LLLS on the occurrence of biliary complications in both donors and recipients. The optimal dose and injection time of ICG were also investigated. From October 2016 to May 2022, the clinical data of 85 donors who underwent LLLS and relevant recipients in the Department of General Surgery of Huashan Hospital were retrospectively analyzed. According to whether ICG fluorescence cholangiography was used, they were divided into a non-ICG group (n=46) and an ICG group (n=39). Biliary complications were observed and the optimal dose and injection time of ICG were explored.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date July 2022
Est. primary completion date May 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. 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. 2. 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. 3. The medical history is complete, which can meet the requirements of this study. 4. Volunteer to participate in this study. Exclusion Criteria: 1. The medical history is incomplete, which cannot meet the requirements of this study. 2. The donor or recipient expressly refused to participate in this study.

Study Design


Related Conditions & MeSH terms

  • Living Donor Liver Transplantation

Intervention

Procedure:
indocyanine green (ICG) fluorescence cholangiography
indocyanine green (ICG) fluorescence cholangiography during operation

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fudan University

Outcome

Type Measure Description Time frame Safety issue
Primary Biliary complications bile leakage and biliary stenosis two months after operation
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