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SALT in Adolescents With End-stage Liver Disease

Primary Purpose

End Stage Liver DIsease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
sequential adolesent left lateral lobe liver transplantation (SALT)
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Liver DIsease focused on measuring liver transplantation, two-stage liver resection, end stage liver dIsease

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 7-18 years old; Patients with end-stage liver disease cannot obtain sufficient donor liver volume through conventional living donor liver transplantation; The general condition is good and can tolerate the follow-up operation plan; Guardians and children (over 14 years old) sign the informed consent. Exclusion Criteria: Uncorrectable cardiopulmonary disease with excessive surgical risk Anatomical abnormalities precluding liver transplantation Patients with primary or secondary hepatic malignancies Patients with genetic metabolic diseases and their complications that cannot be completely cured by liver transplantation Persistent non-adherence to medical care Combined with AIDS and other diseases that affect surgery or tumor progression Other reasons that the researchers think are not suitable for participation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Surgical group

    Arm Description

    SALT operation plan 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.

    Outcomes

    Primary Outcome Measures

    3-year overall survival
    To describe the 3-year overall survival after sequential adolescent left lateral lobe liver transplantation (SALT) in adolescent patients with end-stage liver disease.

    Secondary Outcome Measures

    1-year overall survival
    To describe the 1-year overall survival after sequential adolescent left lateral lobe liver transplantation (SALT) in adolescent patients with end-stage liver disease.

    Full Information

    First Posted
    September 22, 2023
    Last Updated
    October 3, 2023
    Sponsor
    RenJi Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06069050
    Brief Title
    SALT in Adolescents With End-stage Liver Disease
    Official Title
    Sequential Adolescent Left Lateral Lobe Liver Transplantation in Adolescents With End-stage Liver Disease: a Single-center, Prospective, Single-arm Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 20, 2023 (Anticipated)
    Primary Completion Date
    March 30, 2027 (Anticipated)
    Study Completion Date
    March 30, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    RenJi Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    End-stage liver disease is synonymous with advanced liver disease, liver failure, and decompensated cirrhosis, and their disease progression is generally irreversible. Unlike other end-stage diseases, liver transplantation is a definitive and potentially curative treatment for ESLD. However, due to clinical and social factors such as the shortage of donor livers, the number of patients who can be transplanted is far less than the number of waiting patients. About 14% of patients die each year while waiting, and about 10% of patients are too sick to be transplanted. Although changes in organ allocation policies and popularization of living donor liver transplantation have significantly reduced the waiting time and mortality of infant recipients under 2 years old. Pre-transplant mortality in children older than 6 years remains high. Therefore, expanding the donor liver pool is an urgent need to treat patients with adolescent end-stage liver disease (AESLD). In 2015, Norwegian scholars proposed a new surgical method, that is, resection and partial liver segment (2-3 segment) transplantation combined with delayed total hepatectomy can greatly alleviate the shortage of liver donors in the above patients.Based on the experience of clinical operation, our center proposes and designs the clinical research of sequential adolescent left lateral lobe liver transplantation (SALT) for the treatment of AESLD. On the basis of RAPID, the safety and efficacy of sequential juvenile left lateral lobe liver transplantation were evaluated for the above patients.
    Detailed Description
    Cirrhosis is an irreversible advanced stage of chronic progressive liver disease characterized by structural deformation of the liver and the formation of regenerative nodules. Those with complications are classified as decompensated cirrhosis, including variceal bleeding, ascites, spontaneous bacterial peritonitis, hepatocellular carcinoma (HCC), hepatorenal syndrome, or hepatopulmonary syndrome. These complications are the leading cause of death in patients with cirrhosis. End-stage liver disease is synonymous with advanced liver disease, liver failure, and decompensated cirrhosis, and their disease progression is generally irreversible. Unlike other end-stage diseases, liver transplantation is a definitive and potentially curative treatment for ESLD. However, due to clinical and social factors such as the shortage of donor livers, the number of patients who can be transplanted is far less than the number of waiting patients. About 14% of patients die each year while waiting, and about 10% of patients are too sick to be transplanted. Although changes in organ allocation policies and popularization of living donor liver transplantation have significantly reduced the waiting time and mortality of infant recipients under 2 years old. Pre-transplant mortality in children older than 6 years remains high. Therefore, expanding the donor liver pool is an urgent need to treat patients with adolescent end-stage liver disease (AESLD). In 2015, a new surgical method was proposed by Norwegian scholars. Therefore, expanding the donor liver pool is an urgent need to treat patients with adolescent end-stage liver disease (AESLD). In 2015, Norwegian scholars proposed a new surgical method, that is, resection and partial liver segment 2-3 transplantation with delayed total hepatectomy (RAPID). This approach allows transplantation of the left liver (segments 2+3) to an adult recipient, while the remaining enlarged right hemi-liver is transplanted to another adult recipient. Recipients who received right-hemi-liver transplantation had a similar prognosis compared with those who received whole-liver transplantation. Therefore, if the RAPID technique is confirmed to be feasible, it can greatly alleviate the shortage of liver donors. In addition to cadaver sources, living adult donors can also be considered as the source of liver donors. A smaller left lateral lobe donor liver also places less burden on the donor than a left or right hemiliver. To sum up, our center proposed and designed a clinical study of sequential adolescent left lateral lobe liver transplantation (SALT) in the treatment of AESLD patients based on clinical surgical experience. On the basis of RAPID operation, the overall survival rate of SALT in AESLD patients was evaluated.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    End Stage Liver DIsease
    Keywords
    liver transplantation, two-stage liver resection, end stage liver dIsease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    SALT operation plan for patients who meet the enrollment conditions and successfully match the donor liver.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Surgical group
    Arm Type
    Experimental
    Arm Description
    SALT operation plan 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    sequential adolesent left lateral lobe liver transplantation (SALT)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    3-year overall survival
    Description
    To describe the 3-year overall survival after sequential adolescent left lateral lobe liver transplantation (SALT) in adolescent patients with end-stage liver disease.
    Time Frame
    3 years after the second liver resection
    Secondary Outcome Measure Information:
    Title
    1-year overall survival
    Description
    To describe the 1-year overall survival after sequential adolescent left lateral lobe liver transplantation (SALT) in adolescent patients with end-stage liver disease.
    Time Frame
    1 year after the second liver resection

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 7-18 years old; Patients with end-stage liver disease cannot obtain sufficient donor liver volume through conventional living donor liver transplantation; The general condition is good and can tolerate the follow-up operation plan; Guardians and children (over 14 years old) sign the informed consent. Exclusion Criteria: Uncorrectable cardiopulmonary disease with excessive surgical risk Anatomical abnormalities precluding liver transplantation Patients with primary or secondary hepatic malignancies Patients with genetic metabolic diseases and their complications that cannot be completely cured by liver transplantation Persistent non-adherence to medical care Combined with AIDS and other diseases that affect surgery or tumor progression Other reasons that the researchers think are not suitable for participation.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    SALT in Adolescents With End-stage Liver Disease

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