NCT04885582

Brief Summary

Liver transplantation has become the accepted treatment option for advanced liver failure in recent years. In addition to the increase in the number of centers performing transplant and the decrease in complication rates depending on the experience gained, the most common biliary complications did not improve at the desired level. For this reason, studies in this field are frequent today. The structural complexities of HLA antigens have been the subject of investigation in recent years. With the development of DNA and RNA amplification methods; It is increasingly difficult for physicians to keep up with the increasing burden of knowledge regarding the genetic aspects of these antigens. Concrete benefits of this gene complex, which has been investigated in various fields and preserves its mystery, have not been determined in liver transplant patients. However, there are publications showing its connection with the bile epithelium in liver transplantation and its relationship with the disappearing bile duct syndrome. In this study, our aim is to explain whether the bile duct complications, which appear like a continuous wall and can lead to frightening pictures, are related to HLA tissue compatibility.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2021

Completed
Last Updated

May 13, 2021

Status Verified

May 1, 2021

Enrollment Period

2 years

First QC Date

May 11, 2021

Last Update Submit

May 11, 2021

Conditions

Keywords

Liver TransplantComplicationsHLAbiliary fistulabiliary stricture

Outcome Measures

Primary Outcomes (1)

  • Bliary complications

    Biliary fistüla, biliary stenosis

    2 years

Study Arms (2)

Patients with biliary complications

patients with postoperative biliary fistula, biliary stenosis

Other: HLA antigen results

Patients without biliary complications

patients without postoperative biliary fistula and biliary stenosis

Other: HLA antigen results

Interventions

HLA-A, HLA-B, HLA-DR tissue matching results in both groups will be compared.

Patients with biliary complicationsPatients without biliary complications

Eligibility Criteria

Age1 Year - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who had liver transplantation and HLA tissue tests between 2017 and 2019 at Inonu University liver transplant institute

You may qualify if:

  • patients with liver transplantation and tested for HLA antigen (recipient - donor)

You may not qualify if:

  • patients who died early Patients whose HLA antigen is not checked

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health science University - Kayseri State Hospital

Kocasinan, Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Biliary Fistula

Condition Hierarchy (Ancestors)

Digestive System FistulaDigestive System DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

May 11, 2021

First Posted

May 13, 2021

Study Start

May 10, 2017

Primary Completion

May 10, 2019

Study Completion

May 20, 2020

Last Updated

May 13, 2021

Record last verified: 2021-05

Locations