Liver FailureNCT04618692
Biliary Anastomosis Using Surgical Loupe Versus Microscope in Living Donor Liver Transplantation
A study testing Surgical Loupes and Microscope in people with Liver Failure and Liver Diseases, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Comparison of biliary complications in right lobe living donor liver transplantation patients undergoing biliary reconstructions using microscope versus surgical loupes . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Failure, Liver Diseases, Liver Cancer
- What is being tested?
- Surgical Loupes and Microscope
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Dec 2020to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Primary Adult Living donor liver transplant 2.Right lobe grafts with a single biliary orifice
Who cannot join
- 1.Bile duct diameter < 3mm 2.Biliary costructions with a hepaticojejunostomy 3.Right lobe grafts with multipl biliary orifice
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Hospital
Istanbul, 34083
About this study
Official title: Prospective Randomized Single-center Trial Comparing Biliary Anastomosis Using Surgical Loupe Versus Microscope in Living Donor Liver Transplantation
Comparison of biliary complications in right lobe living donor liver transplantation patients undergoing biliary reconstructions using microscope versus surgical loupes .
Read the 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.
- Conditions
- Liver Failure, Liver Diseases, Liver Cancer, Liver Neoplasms, Liver Dysfunction
- Being tested
- Surgical Loupes, Microscope
- Keywords
- Liver transplantation, Living donor liver transplantation, Biliary anastomosis
- Medical subject headings
- Liver Failure, Liver Diseases, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical LoupesOther
Biliary reconstruction will be performed using surgical loupe
MicroscopeOther
Biliary reconstruction will be performed using microscope
| Study group | Role | What they receive |
|---|---|---|
| Surgical Loupes | Active comparator | In this group , patients will undergo biliary reconstruction using surgical loupe Receives: Other: Surgical Loupes |
| Microscope | Active comparator | In this group , patients will undergo biliary reconstruction using microscope Receives: Other: Microscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biliary complications after living donor liver transplantation
Incidence of biliary complications after living donor liver transplantation
Measured: One year
Secondary outcomes (4)
Biliary complications
Types of biliary complications
Measured: One year
Biliary related morbidity
Morbidity
Measured: One year
Perioperative mortality
Mortality
Measured: Through study completion, an average of 1 year
Time to biliary complications
Time to biliary complications
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start2 Dec 2020
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mahmut zenciroğlu, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618692
- Sponsor's protocol ID
- Organ transplantation 1
- Status last verified
- Dec 2025
- First submitted
- 2 Nov 2020
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not plan to share IPD
Publications
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.
PubMed 17580176Lin 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.
PubMed 19938121
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Single-center Trial Comparing Biliary Anastomosis Using Surgical Loupe Versus Microscope in Living Donor Liver Transplantation
- ClinicalTrials.gov ID
- NCT04618692
- Acronym / sponsor ID
- Organ transplantation 1
- Conditions
- Liver Failure, Liver Diseases, Liver Cancer, Liver Neoplasms, Liver Dysfunction
- Keywords
- Liver transplantation, Living donor liver transplantation, Biliary anastomosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Surgical Loupes | Active comparator | Other: Surgical LoupesIn this group , patients will undergo biliary reconstruction using surgical loupe |
| Microscope | Active comparator | Other: MicroscopeIn this group , patients will undergo biliary reconstruction using microscope |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Primary Adult Living donor liver transplant 2.Right lobe grafts with a single biliary orifice
Key exclusion criteria (1 listed)
- 1.Bile duct diameter < 3mm 2.Biliary costructions with a hepaticojejunostomy 3.Right lobe grafts with multipl biliary orifice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical LoupesBiliary reconstruction will be performed using surgical loupe | Other | Surgical Loupes |
| MicroscopeBiliary reconstruction will be performed using microscope | Other | Microscope |
Primary outcome
Biliary complications after living donor liver transplantation
Time frame: One year
Incidence of biliary complications after living donor liver transplantation
4 secondary outcomes
Biliary complications
Time frame: One year
Biliary related morbidity
Time frame: One year
Perioperative mortality
Time frame: Through study completion, an average of 1 year
Time to biliary complications
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Background: PubMed 17580176Yan 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.
- Background: PubMed 19938121Lin 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.
- Individual participant dataSharing planned: No. We will not plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Loupes and Microscope in people with Liver Failure and Liver Diseases, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biliary complications after living donor liver transplantation (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04618692, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.