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

Medipol Health Group

Status: Completed

Conditions: Liver Neoplasms; Liver Failure; Liver Cancer; Liver Dysfunction; Liver Diseases

Treatments: Other: Microscope; Other: Surgical Loupes

Study type: Interventional

Funder types: Other

Identifiers

NCT04618692

Organ transplantation 1

Details and patient eligibility

About

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

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

52 participants in 2 patient groups

Surgical Loupes

Active Comparator group

Description:

In this group , patients will undergo biliary reconstruction using surgical loupe

Treatment:

Other: Surgical Loupes

Microscope

Active Comparator group

Description:

In this group , patients will undergo biliary reconstruction using microscope

Treatment:

Other: Microscope