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

Not Applicable

Completed

• Conditions: Liver Diseases; Liver Neoplasms; Liver Failure; Liver Cancer; Liver Dysfunction
• Interventions: Other: Surgical Loupes; Other: Microscope

• Registration Number: NCT04618692
• Lead Sponsor: Istanbul Medipol University Hospital

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.

Study Timeline

• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2020-11-05
• Study First Posted: 2020-11-06
• Study Start: 2020-12-02
• Primary Completion: 2023-03-30
• Study Completion: 2023-03-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical Loupes	Surgical Loupes	In this group , patients will undergo biliary reconstruction using surgical loupe
Microscope	Microscope	In this group , patients will undergo biliary reconstruction using microscope

Primary Outcome Measures

Name	Time	Method
Biliary complications after living donor liver transplantation	One year	Incidence of biliary complications after living donor liver transplantation

Secondary Outcome Measures

Name	Time	Method
Perioperative mortality	Through study completion, an average of 1 year	Mortality
Biliary complications	One year	Types of biliary complications
Time to biliary complications	One year	Time to biliary complications
Biliary related morbidity	One year	Morbidity

Trial Locations

Locations (1)

Istanbul Medipol University Hospital; 🇹🇷 Istanbul, Turkey