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

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04618692
• Other study ID #: Organ transplantation 1
• Status: Completed
• Phase: N/A
• Start date: December 2, 2020
• Est. completion date: March 30, 2023

Study information

• Verified date: August 2023
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Cancer
• Liver Diseases
• Liver Dysfunction
• Liver Failure
• Liver Neoplasms

Intervention

Other:
• Surgical Loupes
Biliary reconstruction will be performed using surgical loupe
• Microscope
Biliary reconstruction will be performed using microscope

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biliary complications after living donor liver transplantation	Incidence of biliary complications after living donor liver transplantation	One year
Secondary	Biliary complications	Types of biliary complications	One year
Secondary	Biliary related morbidity	Morbidity	One year
Secondary	Perioperative mortality	Mortality	Through study completion, an average of 1 year
Secondary	Time to biliary complications	Time to biliary complications	One year