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

NCT ID: NCT04618692

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-02

Study Completion Date

2023-03-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Liver Failure Liver Diseases Liver Cancer Liver Neoplasms Liver Dysfunction

Keywords

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Liver transplantation Living donor liver transplantation Biliary anastomosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patients 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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

None (Open Label)

Study Groups

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Surgical Loupes

In this group , patients will undergo biliary reconstruction using surgical loupe

Group Type ACTIVE_COMPARATOR

Surgical Loupes

Intervention Type OTHER

Biliary reconstruction will be performed using surgical loupe

Microscope

In this group , patients will undergo biliary reconstruction using microscope

Group Type ACTIVE_COMPARATOR

Microscope

Intervention Type OTHER

Biliary reconstruction will be performed using microscope

Interventions

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Surgical Loupes

Biliary reconstruction will be performed using surgical loupe

Intervention Type OTHER

Microscope

Biliary reconstruction will be performed using microscope

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Medipol University Hospital

OTHER

Sponsor Role lead

Responsible Party

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mahmut zenciroğlu

Primary researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul Medipol University Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 17580176 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19938121 (View on PubMed)

Other Identifiers

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Organ transplantation 1

Identifier Type: -

Identifier Source: org_study_id