Biliary Anastomosis Using Surgical Loupe Versus Microscop... | NCT04618692

Studies
Biliary Anastomosis Using Surgical Loupe Versus Microscope in Living Donor Liver Transplantation

NCT04618692

Sponsor

Istanbul Medipol University Hospital

Status

Completed

Last Update Posted

Dec 18, 2025Actual

Enrollment

52Actual

Phase

Not Applicable

Conditions

Liver Failure
Liver Diseases
Liver Cancer
Liver Neoplasms
Liver Dysfunction

Interventions

Surgical Loupes
Microscope

Countries

Turkey (Türkiye)

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

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2, 2020Actual

Primary Completion Date

Mar 30, 2023Actual

Completion Date

Mar 30, 2023Actual

First Submitted Date

Nov 2, 2020

First Submission Date that Met QC Criteria

Nov 5, 2020

First Posted Date

Nov 6, 2020Actual

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

Dec 10, 2025

Last Update Posted Date

Dec 18, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

mahmut zenciroğlu, Primary researcher, Istanbul Medipol University HospitalPrincipal Investigator

Lead Sponsor

Istanbul Medipol University HospitalOTHER

Collaborators

Not provided

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

Comparison of biliary complications in right lobe living donor liver transplantation patients undergoing biliary reconstructions using microscope versus surgical loupes .

Detailed Description

Liver transplantation (LT) is the most effective treatment modality in patients with end-stage liver disease and it is also established as a viable treatment option in the field of oncology. Living donor liver transplantation (LDLT) using the right lobe (RL) is a major achievement despite its technical challenges, which has created a significant increase in graft supply. While a secure bile duct anastomosis is one of the basic principles of a successful liver transplant procedure, biliary reconstruction remains the Achilles' heel of LDLT because of the high incidence of posttransplant biliary complications associated with significant recipient morbidity and mortality. Some of these complications are related to technical difficulties due to multiple small biliary orifices, particularly in right lobe grafts. In our center, we have been using microsurgical reconstruction technique for duct-to-duct biliary anastomosis in such grafts. The routine use of this technique has been shown to significantly decrease biliary complications in single-center retrospective studies. However, prospective controlled studies comparing microsurgical and standard biliary reconstruction techniques are lacking. In this study, our objective is to compare posttransplant complications of the two techniques of biliary reconstruction in RL LDLT.

40 patients will be included in the study. They will be randomly allocated in the equal groups.İn group 1 biliary anastomosis will be performed using surgical loupes and İn group 2 biliary anastomosis will be performed using microscope. The patients will be followed for one year after the transplant to compare biliary complications.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgical Loupes	Active Comparator	In this group , patients will undergo biliary reconstruction using surgical loupe	Other: Surgical Loupes
Microscope	Active Comparator	In this group , patients will undergo biliary reconstruction using microscope	Other: Microscope

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgical Loupes	Other	Biliary reconstruction will be performed using surgical loupe	Surgical Loupes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Biliary complications after living donor liver transplantation	Incidence of biliary complications after living donor liver transplantation	One year

Secondary Outcomes

Measure	Description	Time Frame
Biliary complications	Types of biliary complications	One year
Biliary related morbidity	Morbidity	One year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1.Primary Adult Living donor liver transplant 2.Right lobe grafts with a single biliary orifice

Exclusion Criteria:

1.Bile duct diameter < 3mm 2.Biliary costructions with a hepaticojejunostomy 3.Right lobe grafts with multipl biliary orifice

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul Medipol University Hospital		Istanbul		34083	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17580176	Background	Yan L, Li B, Zeng Y, Wen T, Zhao J, Wang W, Yang J, Xu M, Ma Y, Chen Z, Liu J, Wu H. Introduction of microsurgical technique to biliary reconstruction in living donor liver transplantation. Transplant Proc. 2007 Jun;39(5):1513-6. doi: 10.1016/j.transproceed.2007.01.091.
19938121	Background	Lin TS, Concejero AM, Chen CL, Chiang YC, Wang CC, Wang SH, Liu YW, Yang CH, Yong CC, Jawan B, Cheng YF. Routine microsurgical biliary reconstruction decreases early anastomotic complications in living donor liver transplantation. Liver Transpl. 2009 Dec;15(12):1766-75. doi: 10.1002/lt.21947.

ID	Term
D048550	Hepatic Insufficiency
D004066	Digestive System Diseases
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

ID	Term
D017093	Liver Failure
D008107	Liver Diseases
D008113	Liver Neoplasms