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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04618692
Enrollment
52
Registered
2020-11-06
Start date
2020-12-02
Completion date
2023-03-30
Last updated
2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Failure, Liver Diseases, Liver Cancer, Liver Neoplasms, Liver Dysfunction

Keywords

Liver transplantation, Living donor liver transplantation, Biliary anastomosis

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.

Interventions

Biliary reconstruction will be performed using surgical loupe

Biliary reconstruction will be performed using microscope

Sponsors

Istanbul Medipol University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

None (Open Label)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Biliary complications after living donor liver transplantationOne yearIncidence of biliary complications after living donor liver transplantation

Secondary

MeasureTime frameDescription
Perioperative mortalityThrough study completion, an average of 1 yearMortality
Time to biliary complicationsOne yearTime to biliary complications
Biliary complicationsOne yearTypes of biliary complications
Biliary related morbidityOne yearMorbidity

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026