SALT in Adolescents With End-stage Liver Disease

NCT06069050 | Not Yet Recruiting

• 1 other identifier: LY2023-184-C
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

End Stage Liver DIsease

Keywords

liver transplantation; two-stage liver resection; end stage liver dIsease

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years after the second liver resection

Secondary Outcomes (1)

• 1-year overall survival

  1 year after the second liver resection

Study Arms (1)

Surgical group

EXPERIMENTAL

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.

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

Interventions

sequential adolesent left lateral lobe liver transplantation (SALT) PROCEDURE

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.

Surgical group

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

MeSH Terms

Conditions

End Stage Liver Disease

Condition Hierarchy (Ancestors)

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

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 operation plan for patients who meet the enrollment conditions and successfully match the donor liver.

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 5, 2023
• Study Start: October 20, 2023
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share