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NCT06331273 Clinical Trial

Impact of "No-touch" Technique on the Outcome of Liver Transplantation for Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:
Impact of "No-touch" Technique on the Outcome of Liver Transplantation for Hepatocellular Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06331273
Other study ID # CT2024-ZJU-OBS3
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2024
Est. completion date April 1, 2028

Study information
Verified date March 2024
Source Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The "no-touch" technique has been one of the most important principles of oncological surgery and aimed to prevent seeding and tumor cell dissemination. Previous studies in hepatectomy have shown that no-touch technique surgery can reduce HCC recurrence and improve the survival of patients. However, there is no consensus on whether the no-touch technique in LT for HCC improves the outcomes. This study aims to prospectively include liver transplant patients from multiple transplant centers, collecting their pre-transplant clinical information, post-transplant pathological records and exploring and clarify the correlation between "no-touch" technique and the prognosis of LT patients.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 800
Est. completion date April 1, 2028
Est. primary completion date April 1, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Diagnosis of HCC based on CT or MRI imaging or needle biopsy confirming a histologic diagnosis of HCC. 2. Patients undergoing deceased donor liver transplantation for the first time. Exclusion Criteria: (1) patients who received split LT or simultaneous transplantation, (2) patients who received re-transplantation, (3) patients with macroscopic portal vein tumor thrombosis or other macrovascular invasion, (4) patients with incomplete follow-up or incomplete important parameters records.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Liver transplantation with "No-touch" technique
The core principle of "no-touch" tumor surgery revolves around avoiding direct contact with the tumor or surrounding tissues as much as possible to minimize the release of cancer cells into the bloodstream or nearby tissues.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Zhejiang University Shulan (Hangzhou) Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrence free surviavl rate 2024.4.1-2028.4.1
Primary Overall survival rate 2024.4.1-2028.4.1
Primary Tumor recurrence rate 2024.4.1-2028.4.1
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