End Stage Liver DIseaseNCT06069050
SALT in Adolescents With End-stage Liver Disease
A study testing sequential adolesent left lateral lobe liver transplantation (SALT) in people with End Stage Liver DIsease, run by RenJi Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- End Stage Liver DIsease
- What is being tested?
- sequential adolesent left lateral lobe liver transplantation (SALT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2023to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- End Stage Liver DIsease
- Being tested
- sequential adolesent left lateral lobe liver transplantation (SALT)
- Keywords
- liver transplantation, two-stage liver resection, end stage liver dIsease
- Medical subject headings
- End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sequential adolesent left lateral lobe liver transplantation (SALT)Procedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: sequential adolesent left lateral lobe liver transplantation (SALT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years after the second liver resection
Secondary outcomes (1)
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.
Measured: 1 year after the second liver resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start20 Oct 2023 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Liver DIseaseStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- SALT operation plan for patients who meet the enrollment conditions and successfully match the donor liver.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069050
- Sponsor's protocol ID
- LY2023-184-C
- Status last verified
- Oct 2023
- First submitted
- 22 Sep 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Adolescent Left Lateral Lobe Liver Transplantation in Adolescents With End-stage Liver Disease: a Single-center, Prospective, Single-arm Study
- ClinicalTrials.gov ID
- NCT06069050
- Acronym / sponsor ID
- LY2023-184-C
- Conditions
- End Stage Liver DIsease
- Keywords
- liver transplantation, two-stage liver resection, end stage liver dIsease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 20 Oct 2023 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- SALT operation plan for patients who meet the enrollment conditions and successfully match the donor liver.
| Arm | Type | Receives |
|---|---|---|
| Surgical group | Experimental | Procedure: sequential adolesent left lateral lobe liver transplantation (SALT)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. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Surgical group |
Primary outcome
3-year overall survival
Time frame: 3 years after the second liver resection
To describe the 3-year overall survival after sequential adolescent left lateral lobe liver transplantation (SALT) in adolescent patients with end-stage liver disease.
1 secondary outcome
1-year overall survival
Time frame: 1 year after the second liver resection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing sequential adolesent left lateral lobe liver transplantation (SALT) in people with End Stage Liver DIsease, run by RenJi Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year overall survival (time frame: 3 years after the second liver resection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.