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

Ru-zhou Cai

Status: Invitation-only

Conditions: Liver Transplantation

Study type: Observational

Funder types: Other

Identifiers

NCT07247877

BFHHZML20250022

Details and patient eligibility

About

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?"

Enrollment: 396 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

396 participants in 2 patient groups

auxiliary liver transplantation using small-for-size grafts

conventional liver transplantation using Standard-size graft