SALT for Treatment of Patients With Early ACLF

NCT06069037 | Unknown

• 1 other identifier: LY2023-183-C
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sequential Adult Liver transplantation; Left lateral segment; Portal inflow modulation; Acute-on-chronic liver failure

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  To describe overall survival in patients with ACLF treated with sequential adult left lateral lobe liver transplantation.

  1 year after second stage hepatectomy

Secondary Outcomes (2)

• Graft Survival (GS)

  1 year after second stage hepatectomy

• Postoperative complications

  90 days after liver transplant

Study Arms (1)

SALT surgery

EXPERIMENTAL

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

Procedure: sequential adult left lateral lobe liver transplantation (SALT)

Interventions

sequential adult left lateral lobe liver transplantation (SALT) PROCEDURE

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.

SALT surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years old
• Diagnosed as acute-on-choronic liver failure according to APASL definition
• The severity of chronic and acute liver failure is diagnosed as level 1-2 according to the CANONIC criteria
• Signed informed consent and expected cooperation of the patients for treatment and follow up.

You may not qualify if:

• Clinical Frailty Scale score ≥ 7 points
• Severe hepatopulmonary syndrome, moderate to severe portal pulmonary hypertension; Surgical procedures with high risk of cardiovascular and pulmonary diseases
• Complicated with sepsis, various site infections such as spontaneous peritonitis, biliary tract infections, lung infections, bloodstream infections, urinary system infections, etc., did not improve after 72 hours of anti infection before transplantation; Gram negative bacterial infections resistant to carbapenems within the past 3 months
• Grade III-IV hepatic encephalopathy (West Haven classification), shock (with a dose of more than 1ug/Kg/min for demethylated kidney), PaO2/FiO2 value ≤ 150mmHg, renal failure requiring dialysis treatment
• Lactic acid greater than 9umol/L
• Special types of anatomical variations (such as portal vein III-IV type, etc.)
• Severe mental and psychological disorders
• Complicated with other diseases such as AIDS or malignant tumors
• Any reason why, in the opinion of the investigator, the patient should not participate

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, 200127, China

Location

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Jianjun Zhang, MD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongbing Qian, MD

CONTACT

86-21-68383715; qianyb79@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 5, 2023
• Study Start: October 15, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)