SALT in Adolescents With End-stage Liver Disease

Sequential Adolescent Left Lateral Lobe Liver Transplantation in Adolescents With End-stage Liver Disease: a Single-center, Prospective, Single-arm Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: End Stage Liver DIsease
• Intervention / Treatment: Procedure: sequential adolesent left lateral lobe liver transplantation (SALT)

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 7-18 years old;
2. Patients with end-stage liver disease cannot obtain sufficient donor liver volume through conventional living donor liver transplantation;
3. The general condition is good and can tolerate the follow-up operation plan;
4. Guardians and children (over 14 years old) sign the informed consent.

Exclusion Criteria:

1. Uncorrectable cardiopulmonary disease with excessive surgical risk
2. Anatomical abnormalities precluding liver transplantation
3. Patients with primary or secondary hepatic malignancies
4. Patients with genetic metabolic diseases and their complications that cannot be completely cured by liver transplantation
5. Persistent non-adherence to medical care
6. Combined with AIDS and other diseases that affect surgery or tumor progression
7. Other reasons that the researchers think are not suitable for participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgical group; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year after the second liver resection

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 20, 2023
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2027

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: liver transplantation; two-stage liver resection; end stage liver dIsease
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Liver Diseases; End Stage Liver Disease
• Other Study ID Numbers: LY2023-184-C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No