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SALT for Treatment of Patients With Early ACLF

NCT06069037 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-10-05

No results posted yet for this study

Summary

ACLF is a syndrome characterized by rapid deterioration of liver function in chronic liver disease or undiagnosed chronic liver disease, with a high risk of short-term death. Both CMA and EASL mentioned that there is currently lack of specific drugs and treatment of liver failure. For patients with ACLF who are still graded as 2 or 3 after active medical treatment and/or artificial liver therapy, and the CLIF-C score is less than 64 points, it is recommended to perform liver transplantation as soon as possible within 28 days. Early liver transplantation is crucial for improving the prognosis of ACLF, reducing the risk of postoperative infection, progression from early ACLF to late ACLF, and further improving the 1-year post-transplant survival. The current priority for liver allocation based on MELD-Na can't give priority to liver donor matching to ACLF 1-2. Therefore, expanding the donor liver pool is an urgent need for early treatment of patients with ACLF. France team reviewed the development of APOLT to RAPID technology in liver transplantation for liver cirrhosis. Among them, 9 cases underwent two-step hepatectomy (including 5 cases of orthotopic assisted liver transplantation and 4 cases of RAPID surgery), 8 patients survived until the end of follow-up. Based on the experience of clinical practice, our center proposes and designs a clinical study of sequential adult left lateral lobe liver transplantation (SALT) for the treatment of early ACLF (Grade 1 and 2). On the basis of APOLT and RAPID, the safety and efficacy of sequential adult left lateral lobe liver transplantation were evaluated for the above patients.

Conditions

  • Acute-On-Chronic Liver Failure

Interventions

PROCEDURE

sequential adult left lateral lobe liver transplantation (SALT)

SALT for patients who meet the enrollment conditions and successfully match the donor liver: Hemihepatectomy combined with left lateral lobe liver transplantation was performed first, and residual liver resection was performed after the graft grew to a sufficient functional liver volume.

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Jianjun Zhang, MD · RenJi Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-15
Primary Completion
2024-12-30
Completion
2025-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06069037 on ClinicalTrials.gov