Clinical trial NCT04618692: Biliary Anastomosis Using Surgical Loupe Versus Microscope in Living Donor Liver Transplantation
Official title: Prospective Randomized Single-center Trial Comparing Biliary Anastomosis Using Surgical Loupe Versus Microscope in Living Donor Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Failure
Liver Diseases
Liver Cancer
Liver Neoplasms
Liver Dysfunction
Keywords: Liver transplantation
Living donor liver transplantation
Biliary anastomosis
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Biliary complications after living donor liver transplantation
timeFrame: One year
Secondary outcomes:
measure: Biliary complications
timeFrame: One year
measure: Biliary related morbidity
timeFrame: One year
measure: Perioperative mortality
timeFrame: Through study completion, an average of 1 year
measure: Time to biliary complications
timeFrame: One year
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University Hospital
Study officials:
References:
citation: 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.
citation: 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.