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

March 20, 2024 updated by: Xiao Xu, Zhejiang University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

800

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

HCC patients who undergoing deceased donor liver transplantation for the first time.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HCC patients fulfill Hangzhou criteria and receive LT with "No-touch" technique
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.
HCC patients exceed Hangzhou criteria and receive LT with "No-touch" technique
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.
HCC patients fulfill Hangzhou criteria and receive LT without "No-touch" technique
HCC patients exceed Hangzhou criteria and receive LT without"No-touch" technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival rate
Time Frame: 2024.4.1-2028.4.1
2024.4.1-2028.4.1
Tumor recurrence rate
Time Frame: 2024.4.1-2028.4.1
2024.4.1-2028.4.1
Recurrence free surviavl rate
Time Frame: 2024.4.1-2028.4.1
2024.4.1-2028.4.1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Collaborators

Shulan (Hangzhou) Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

March 20, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT2024-ZJU-OBS3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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