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

NCT04618692 | Completed

• 1 other identifier: Organ transplantation 1
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Failure; Liver Diseases; Liver Cancer; Liver Neoplasms; Liver Dysfunction

Keywords

Liver transplantation; Living donor liver transplantation; Biliary anastomosis

Outcome Measures

Primary Outcomes (1)

• Biliary complications after living donor liver transplantation

  Incidence of biliary complications after living donor liver transplantation

  One year

Secondary Outcomes (4)

• Biliary complications

  One year

• Biliary related morbidity

  One year

• Perioperative mortality

  Through study completion, an average of 1 year

• Time to biliary complications

  One year

Study Arms (2)

Surgical Loupes

ACTIVE COMPARATOR

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

Other: Surgical Loupes

Microscope

ACTIVE COMPARATOR

In this group , patients will undergo biliary reconstruction using microscope

Other: Microscope

Interventions

Surgical Loupes OTHER

Biliary reconstruction will be performed using surgical loupe

Surgical Loupes

Microscope OTHER

Biliary reconstruction will be performed using microscope

Microscope

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary Adult Living donor liver transplant 2.Right lobe grafts with a single biliary orifice

You may not qualify if:

• Bile duct diameter \< 3mm 2.Biliary costructions with a hepaticojejunostomy 3.Right lobe grafts with multipl biliary orifice

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, 34083, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 17580176 BACKGROUND

• 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.

  PMID: 19938121 BACKGROUND

MeSH Terms

Conditions

Liver Failure; Liver Diseases; Liver Neoplasms

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Digestive System Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary researcher

Model Details: 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.

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 6, 2020
• Study Start: December 2, 2020
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)