Biliary Anastomosis Using Surgical Loupe Versus Microscope in Living Donor Liver Transplantation
Primary Purpose
Liver Failure, Liver Diseases, Liver Cancer
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Surgical Loupes
Microscope
Sponsored by
About this trial
This is an interventional treatment trial for Liver Failure focused on measuring Liver transplantation, Living donor liver transplantation, Biliary anastomosis
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
Sites / Locations
- Istanbul Medipol University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Surgical Loupes
Microscope
Arm Description
In this group , patients will undergo biliary reconstruction using surgical loupe
In this group , patients will undergo biliary reconstruction using microscope
Outcomes
Primary Outcome Measures
Biliary complications after living donor liver transplantation
Incidence of biliary complications after living donor liver transplantation
Secondary Outcome Measures
Biliary complications
Types of biliary complications
Biliary related morbidity
Morbidity
Perioperative mortality
Mortality
Time to biliary complications
Time to biliary complications
Full Information
NCT ID
NCT04618692
First Posted
November 2, 2020
Last Updated
August 21, 2023
Sponsor
Istanbul Medipol University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04618692
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 2, 2020 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
March 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Failure, Liver Diseases, Liver Cancer, Liver Neoplasms, Liver Dysfunction
Keywords
Liver transplantation, Living donor liver transplantation, Biliary anastomosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Masking Description
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgical Loupes
Arm Type
Active Comparator
Arm Description
In this group , patients will undergo biliary reconstruction using surgical loupe
Arm Title
Microscope
Arm Type
Active Comparator
Arm Description
In this group , patients will undergo biliary reconstruction using microscope
Intervention Type
Other
Intervention Name(s)
Surgical Loupes
Intervention Description
Biliary reconstruction will be performed using surgical loupe
Intervention Type
Other
Intervention Name(s)
Microscope
Intervention Description
Biliary reconstruction will be performed using microscope
Primary Outcome Measure Information:
Title
Biliary complications after living donor liver transplantation
Description
Incidence of biliary complications after living donor liver transplantation
Time Frame
One year
Secondary Outcome Measure Information:
Title
Biliary complications
Description
Types of biliary complications
Time Frame
One year
Title
Biliary related morbidity
Description
Morbidity
Time Frame
One year
Title
Perioperative mortality
Description
Mortality
Time Frame
Through study completion, an average of 1 year
Title
Time to biliary complications
Description
Time to biliary complications
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Istanbul Medipol University Hospital
City
Istanbul
ZIP/Postal Code
34083
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We will not plan to share IPD
Citations:
PubMed Identifier
17580176
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.
Results Reference
background
PubMed Identifier
19938121
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.
Results Reference
background
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Biliary Anastomosis Using Surgical Loupe Versus Microscope in Living Donor Liver Transplantation
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