Research on Using Small-for-size Grafts for Auxiliary Liver Transplantation in the Treatment of Portal Hypertension

Innovative Technology Research on Using Small-for-size Grafts for Auxiliary Liver Transplantation in the Treatment of Portal Hypertension

The objective of this observational study is to compare the safety profile of auxiliary liver transplantation using small-for-size grafts with that of conventional liver transplantation and to evaluate the efficacy of this technique. The primary research question it seeks to investigate is:

"What are the differences in safety and efficacy between auxiliary liver transplantation utilizing small-for-size grafts and conventional liver transplantation for the treatment of portal hypertension?"

Study Overview

• Status: Enrolling by invitation
• Conditions: Liver Transplantation

• Study Type: Observational
• Enrollment (Estimated): 396

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with cirrhotic portal hypertension who were treated at the Liver Transplantation Center of Beijing Friendship Hospital, Capital Medical University between January 2014 and December 2028, and who underwent either auxiliary liver transplantation using small-for-size grafts (study group) or conventional liver transplantation (control group).

Description

Inclusion Criteria:

1. Age > 14 years.
2. Presence of decompensated portal hypertension.
3. Meeting the indications for liver transplantation surgery.
4. International Normalized Ratio (INR) < 2.4.
5. Scheduled to undergo orthotopic auxiliary partial liver transplantation or conventional liver transplantation.

Exclusion Criteria:

1. Rare liver-related anatomical variations.
2. Presence of contraindications to liver transplantation combined with malignant tumors.
3. Grade III or higher portal vein thrombosis.
4. Severe systemic diseases unrelated to the etiology or complications of portal hypertension.
5. Special surgical procedures such as dual-graft liver transplantation.
6. Special graft sources including domino liver transplantation.
7. Liver re-transplantation.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
auxiliary liver transplantation using small-for-size grafts
conventional liver transplantation using Standard-size graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall survival	Within one year after liver transplantation
Complications	Within one year after liver transplantation
portal hypertension resolution	Within one year after liver transplantation

Collaborators and Investigators

• Sponsor: Zhi-Jun Zhu

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: BFHHZML20250022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No