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Not yet recruiting NCT06153914

SALT for Patients With Hepatic Cirrhosis

No phase Interventional Liver Cirrhosis Liver

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sequential Adult Left Lateral Liver Transplantation.
Who it may be relevant to
Registry conditions: Liver Cirrhosis, Liver. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Clinical Study of the Effectiveness of Sequential Adult Left Lateral Lobe Liver Transplantation in Patients With Hepatitis B Cirrhosis: a Single-center, Prospective, Single-arm Study

Overview

Hepatitis B virus (HBV) infection is a very difficult public health problem in the world. Patients often experience the trilogy of "hepatitis-cirrhosis-liver cancer". Patients with decompensated cirrhosis may develop a variety of complications, such as portal hypertension, hypersplenism, esophageal and gastric variceal bleeding, ascites, spontaneous peritonitis, hepatic encephalopathy, etc. Liver transplantation is the only way to cure hepatitis B cirrhosis. However, the shortage of liver donors still severely limits its development. In 2015, Line and others proposed a new surgical method, namely resection and partial liver segment 2-3 transplantation with delayed total hepatectomy (RAPID). This surgery innovatively combines auxiliary liver transplantation and ALLPS surgery, which can greatly alleviate the problem of liver donor shortage and improve the overall prognosis of the above-mentioned patients. Our center has designed the Sequential Adult Left Lateral Liver Transplantation (SALT) procedure based on the principles of RAPID surgery and the characteristics of patients with cirrhosis. Compared with RAPID surgery, SALT surgery can dynamically monitor and regulate the blood flow of the residual liver and transplanted liver, reducing the risk caused by portal hypertension. This study will evaluate the safety and effectiveness of SALT in the treatment of post-hepatitis B cirrhosis.

Interventions

  • Procedure Sequential Adult Left Lateral Liver Transplantation
    Hemihepatectomy combined with orthotopic left lateral lobe liver transplantation is performed first, and residual liver resection is performed after the graft has grown to a sufficient functional liver volume. After the two-stage surgery, we will follow up on all subjects for one year.

Primary outcome measures

  • survival rate [Time frame: 1 month, 3 months, 6 months and 1 year post-transplant]

Eligibility criteria

Inclusion criteria

  • ①Age 18-75 years old;
  • Have a history of hepatitis B infection;
  • The imaging results are consistent with the manifestations of liver cirrhosis;
  • One of the following conditions: Meld score 15-40 points, esophageal and gastric variceal bleeding, refractory ascites, recurrent hepatic encephalopathy, hepatorenal syndrome, or hepatopulmonary syndrome; ⑤PS score 0-1 points; ⑥Sign the informed consent form.

Exclusion criteria

  • ①Severe thrombosis or cavernous degeneration in the portal vein system, and liver transplantation is contraindicated upon evaluation;
  • Hepatic encephalopathy stage IV;
  • Pulmonary arterial hypertension (moderate to high risk, WHO grade III-IV) that does not improve after medical treatment or is assessed to have contraindications for surgery; ④Special types of anatomical variations;
  • Inability to tolerate surgical anesthesia (such as severe infection, cardiopulmonary insufficiency, cerebrovascular disease, etc.); ⑥Severe mental illness; ⑦Other reasons that the researcher believes are not suitable for participation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06153914 · LY2023-223

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗