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

NCT06331273 | Not Yet Recruiting

• 1 other identifier: CT2024-ZJU-OBS3
• Study Type: observational
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Liver Transplantation; No-touch Technique; Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (3)

• Recurrence free surviavl rate

  2024.4.1-2028.4.1

• Overall survival rate

  2024.4.1-2028.4.1

• Tumor recurrence rate

  2024.4.1-2028.4.1

Study Arms (4)

HCC patients fulfill Hangzhou criteria and receive LT with "No-touch" technique

Procedure: Liver transplantation with "No-touch" technique

HCC patients exceed Hangzhou criteria and receive LT with "No-touch" technique

Procedure: Liver transplantation with "No-touch" technique

HCC patients fulfill Hangzhou criteria and receive LT without "No-touch" technique

HCC patients exceed Hangzhou criteria and receive LT without"No-touch" technique

Interventions

Liver transplantation with "No-touch" technique PROCEDURE

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; HCC patients fulfill Hangzhou criteria and receive LT with "No-touch" technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Diagnosis of HCC based on CT or MRI imaging or needle biopsy confirming a histologic diagnosis of HCC.
• Patients undergoing deceased donor liver transplantation for the first time.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Zhejiang University: lead
• Shulan (Hangzhou) Hospital: collaborator

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 26, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 26, 2024

Record last verified: 2024-03