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OpenTrials
Completed

NCT Number: NCT04618692

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University Hospital

Istanbul, 34083, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical Loupes

Other

Biliary reconstruction will be performed using surgical loupe

Microscope

Other

Biliary reconstruction will be performed using microscope

Primary outcomes

  1. Biliary complications after living donor liver transplantation

    Time frame: One year

    Incidence of biliary complications after living donor liver transplantation

Secondary outcomes

  1. Biliary complications

    Time frame: One year

    Types of biliary complications

  2. Biliary related morbidity

    Time frame: One year

    Morbidity

  3. Perioperative mortality

    Time frame: Through study completion, an average of 1 year

    Mortality

  4. Time to biliary complications

    Time frame: One year

    Time to biliary complications

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

Prospective Randomized Single-center Trial Comparing Biliary Anastomosis Using Surgical Loupe Versus Microscope in Living Donor Liver Transplantation

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 6, 2020
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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