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

NCT07247877 | Enrolling By Invitation

• 1 other identifier: BFHHZML20250022
• Study Type: observational
• Target: 396
• Locations: 0 countries
• Sites: N/A

Brief Summary

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?"

Conditions

Liver Transplantation

Outcome Measures

Primary Outcomes (3)

• overall survival

  Within one year after liver transplantation

• Complications

  Within one year after liver transplantation

• portal hypertension resolution

  Within one year after liver transplantation

Study Arms (2)

auxiliary liver transplantation using small-for-size grafts

conventional liver transplantation using Standard-size graft

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ru-zhou Cai: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: January 1, 2014
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: November 25, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share