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

Sponsor
Istanbul Medipol University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04618692
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
27.9
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Surgical Loupes
  • Other: Microscope
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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)
Primary Purpose:
Treatment
Official Title:
Prospective Randomized Single-center Trial Comparing Biliary Anastomosis Using Surgical Loupe Versus Microscope in Living Donor Liver Transplantation
Actual Study Start Date :
Dec 2, 2020
Anticipated Primary Completion Date :
Mar 30, 2023
Anticipated Study Completion Date :
Mar 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Surgical Loupes

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

Other: Surgical Loupes
Biliary reconstruction will be performed using surgical loupe
Active Comparator: Microscope

In this group , patients will undergo biliary reconstruction using microscope

Other: Microscope
Biliary reconstruction will be performed using microscope

Outcome Measures

Primary Outcome Measures

  1. Biliary complications after living donor liver transplantation [One year]

    Incidence of biliary complications after living donor liver transplantation

Secondary Outcome Measures

  1. Biliary complications [One year]

    Types of biliary complications

  2. Biliary related morbidity [One year]

    Morbidity

  3. Perioperative mortality [Through study completion, an average of 1 year]

    Mortality

  4. Time to biliary complications [One year]

    Time to biliary complications

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Medipol University Hospital Istanbul Turkey 34083

Sponsors and Collaborators

  • Istanbul Medipol University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
mahmut zenciroğlu, Primary researcher, Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier:
NCT04618692
Other Study ID Numbers:
  • Organ transplantation 1
First Posted:
Nov 6, 2020
Last Update Posted:
Mar 21, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by mahmut zenciroğlu, Primary researcher, Istanbul Medipol University Hospital
Liver transplantation
Living donor liver transplantation
Biliary anastomosis
Additional relevant MeSH terms:
Liver Neoplasms
Liver Diseases
Liver Failure

Study Results

No Results Posted as of Mar 21, 2022