The Relationship Between HLA Tissue Compatibility and Biliary Complications in Patients With Liver Transplantation

• Sponsor: Inonu University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04885582
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Actual Duration (Months): 36.3
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Transplant; Complications; HLA Antigens	Other: HLA antigen results

Study Design

• Study Type: Observational
• Actual Enrollment: 80 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: The Relationship Between HLA Tissue Compatibility and Biliary Complications in Patients With Liver Transplantation
• Actual Study Start Date: May 10, 2017
• Actual Primary Completion Date: May 10, 2019
• Actual Study Completion Date: May 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Patients with biliary complications patients with postoperative biliary fistula, biliary stenosis	Other: HLA antigen results; HLA-A, HLA-B, HLA-DR tissue matching results in both groups will be compared.
Patients without biliary complications patients without postoperative biliary fistula and biliary stenosis	Other: HLA antigen results; HLA-A, HLA-B, HLA-DR tissue matching results in both groups will be compared.

Outcome Measures

Primary Outcome Measures

1. Bliary complications [2 years]

   Biliary fistüla, biliary stenosis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Health science University - Kayseri State Hospital	Kocasinan	Kayseri	Turkey

Sponsors and Collaborators

• Inonu University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ersin Gündoğan, Assoc Prof, Inonu University
• ClinicalTrials.gov Identifier: NCT04885582
• Other Study ID Numbers: 2017/133
• First Posted: May 13, 2021
• Last Update Posted: May 13, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ersin Gündoğan, Assoc Prof, Inonu University: Liver Transplant; Complications; HLA; biliary fistula; biliary stricture

Study Results

No Results Posted as of May 13, 2021