Long-Term Outcomes of ABO-Incompatible Versus Compatible... | NCT07105085

Studies
Long-Term Outcomes of ABO-Incompatible Versus Compatible Living Donor Liver Transplantation

NCT07105085

Sponsor

Seoung Hoon Kim

Status

Terminated

Last Update Posted

Aug 5, 2025Actual

Enrollment

511Actual

Phase

Not provided

Conditions

Liver Transplantation
Liver Diseases

Interventions

living donor liver transplantation

Countries

Not provided

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

in order to get sufficient follow-up period and judged to be gather enough subjects

Expanded Access Info

Start Date

Jan 1, 2012Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Jul 1, 2025Actual

First Submitted Date

Jul 29, 2025

First Submission Date that Met QC Criteria

Jul 29, 2025

First Posted Date

Aug 5, 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

Jul 29, 2025

Last Update Posted Date

Aug 5, 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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study aims to compare overall survival and the incidence of biliary complications.

Detailed Description

This retrospective cohort study investigates the long-term outcomes of ABO-incompatible (ABO-I) versus ABO-compatible (ABO-C) living donor liver transplantation (LDLT). A total of 511 patients underwent LDLT between January 2012 and December 2022 at a single high-volume transplant center in Korea. Among them, 121 received ABO-I grafts using a rituximab-based desensitization protocol, while 390 underwent ABO-C LDLT. The study aims to compare overall survival and the incidence of biliary complications, as well as to identify risk factors specific to each group. This analysis provides insights into the long-term safety and efficacy of ABO-I LDLT in regions with low deceased donor organ availability.

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

511Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
living donor liver transplantation	Procedure	other intervention cannot be applied.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of biliary complications	Statistical analyses are conducted to determine the incidence of biliary complication.	within 10 years post-transplantation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All adult patients who underwent LDLT at the study center from 2012 to 2022

Exclusion Criteria:

Pediatric patients, deceased donor recipients, multi-organ transplants.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

the patients who underwent living donor liver transplantation

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Seoung Hoon kim, MD, PhD	National Cancer Center	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

The data that support the findings of this study are not publicly available due to institutional and ethical restrictions but are available from the corresponding author on reasonable request and with permission from the institution.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided