Application of in Vivo Splitting Technique in Adult Liver... | NCT06925828

Studies
Application of in Vivo Splitting Technique in Adult Liver Transplantation

NCT06925828

Sponsor

Ningbo Medical Center Lihuili Hospital

Status

Active, not recruiting

Last Update Posted

Apr 13, 2025Actual

Enrollment

500Actual

Phase

Not provided

Conditions

Liver Transplantation

Interventions

No intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Apr 7, 2025

First Submission Date that Met QC Criteria

Apr 7, 2025

First Posted Date

Apr 13, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2025

Last Update Posted Date

Apr 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The feasibility of split liver transplantation (SLT) remains controversial. This study aimed to evaluate the outcomes of SLT in adult recipients and to identify specific areas of improvements. A retrospective analysis was conducted on adults who underwent full size SLT between January 2021 and December 2023. The short-term outcomes of these patients who underwent SLT were compared with those of patients who underwent whole liver transplantation (WLT) during the same period.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SLT group		Adult recipients who underwent split liver transplantation	Other: No intervention
WLT group		Adult recipients who underwent whole liver transplantation	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	SLT group WLT group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	the overall survival of liver transplant recipient during study period	2021.01.01-2025.12.31

Secondary Outcomes

Measure	Description	Time Frame
Postoperative complications	Postoperative complications of liver transplant recipient during study period	2021.01.01-2025.12.31

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

For the donor graft:
1. age of 18-60 years;
2. BMI of 19-28 kg/m2;
3. hemodynamic stability or use of a single vasoactive drug with a small dosage (norepinephrine ≤ 0.1 μg/kg/min or dopamine ≤ 5 μg/kg/min);
4. liver steatosis ≤ 10%;
5. liver functional indicators (ALT, AST, total bilirubin quantification) ≤ 3 times the normal value;
6. blood sodium ≤ 160 mmol/L;

For the SLT recipients

Patients who had registered in the China Organ Transplant Response Systems.
Initial liver transplantation.
Graft-to-Recipient Weight Ratio (GRWR) ≥ 1%.

Exclusion Criteria:

For the donor graft
1. uncontrollable infection
2. significant vascular and biliary variation.

For the recipients

Severe portal hypertension.
Significant vascular variation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Adult recipients who underwent SLT or WLT

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ningbo Medical Centre Lihuili Hospital		Ningbo	Zhejiang	315000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided