Liver Transplant; ComplicationsNCT06533592
The Effect of the Type of Conduit-duct Anastomosis Technique on the Postoperative Course in Patients Undergoing Liver Transplantation
A study testing Continous suture technique and Interrupted suture technique in people with Liver Transplant; Complications and Bile Duct; Stricture, Postoperative, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The main objective of the trial is to compare the effect of two end-to-end duct-to-duct anastomosis surgical techniques using the continuous suture method versus interrupted method (control group) on reducing the risk of bile leakages in the 90-day follow-up period after liver transplantation and other postoperative… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Transplant; Complications, Bile Duct; Stricture, Postoperative, Bile Leak
- What is being tested?
- Continous suture technique and Interrupted suture technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 sitePoland
- Study dates
- 28 Sep 2024to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- age over 18
- elective liver transplantation
- informed consent to participate in the study
- recipient bile duct diameter over 3mm
- donor bile duct diameter over 3mm
Who cannot join
- age below 18
- pregnancy
- living donor liver transplantation
- split-liver or reduced-size liver transplantation
- liver transplantation other than from brain death donor
- liver transplantation with hepaticojejunostomy
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- patients undergoing re-transplantation
- multi-organ transplantation
- recipient bile duct diameter below 3mm
- donor bile duct diameter below 3mm
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of General, Transplantation and Liver Surgery UCC MUW
Warsaw, Masovian Voivodeship, 02-097
Krzysztof Dudek, MD, PhD, +48 225992542, krzysztof.dudek@wum.edu.pl
Jan Stypułkowski, MD, +48 225992459, jan.stypulkowski@wum.edu.pl
About this study
Official title: A Prospective Randomized Study to Evaluate the Effect of the Type of Conduit-duct Anastomosis Using the Single/continuous Suture Technique on the Postoperative Course in Patients Undergoing Liver Transplantation from a Deceased Donor.
The main objective of the trial is to compare the effect of two end-to-end duct-to-duct anastomosis surgical techniques using the continuous suture method versus interrupted method (control group) on reducing the risk of bile leakages in the 90-day follow-up period after liver transplantation and other postoperative complications resulting from them i.e.: the occurrence of a critical stenosis in the duct-to-duct anastomosis within 90 days. In addition, as part of the research experiment, long-term biliary complications will be assessed, i.e. occurring over a period of more than 90 days (a 2-year observation period of patients was assumed).
As part of the trial 284 patients qualified for the procedure of liver transplantation from a deceased donor will be included, in whom end-to-end anastomosis of the bile ducts will be performed. After entering the study, patients will be randomized to one of the groups. In the group of 142 patients, duct-to-duct anastomosis will be performed using an interrupted suture (control group), and the remaining patients will be performed using the continuous suture technique.
Read more
The analysis will also include surgical complications, complications related to early and late graft function, retransplantation and overall survival.
Additionally the analyses an analysis of the impact of the occurrence of a biliary complication on the quality of life of patients after liver transplantation will be performed on the basis of the EORTC QLQ-C30 forms.
The period of observation of the patient after the procedure is planned for 24 months.
- Conditions
- Liver Transplant; Complications, Bile Duct; Stricture, Postoperative, Bile Leak, Quality of Life
- Being tested
- Continous suture technique, Interrupted suture technique
- Medical subject headings
- Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continous suture techniqueProcedure or surgery
Duct-to-duct anastomosis will be performed using continuous suture technique for study group
Interrupted suture techniqueProcedure or surgery
Duct-to-duct anastomosis will be performed using an interrupted suture for control group,
| Study group | Role | What they receive |
|---|---|---|
| Continuous suture technique | Experimental | Biliary duct-to-duct anastomosis performed with continous suture technique Receives: Procedure: Continous suture technique |
| Interrupted suture | Active comparator | Biliary duct-to-duct anastomosis performed with interrupted suture technique - control group Receives: Procedure: Interrupted suture technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bile leakage
Defined as bilirubin concentration in the drain fluid at least 3 times the serum bilirubin concentration or as the need for radiologic or operative intervention resulting from biliary collections or bile peritonitis up to 90 days post transplantation
Measured: 90 days post transplantation
Secondary outcomes (6)
Critical biliary stricture
Defined as the need for radiologic, endoscopic or operative intervention resulting from increased serum bilirubin concentration
Measured: 90 days post transplantation
Other surgical complications
Occurence of complication assessed in Clavien-Dindo scale
Measured: 90 days post transplantation
Long-term biliary complications
Defined as occurence of biliary leak, biliary stricture, peripheral cholangiopathy, recurrent cholangitis between 90 days and 2 years post transplantation
Measured: 2 years post transplantation
Overall survival
Measured: 2 years post transplantation
Overall graft survival
Measured: 2 years post transplantation
Impact of the occurrence of a biliary complication on the quality of life of patients
Evaluated with EORTC QLQ-C30 form
Measured: 2 years post transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start28 Sep 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533592
- Sponsor's protocol ID
- 2023/ABM/01/00017
- Status last verified
- Jun 2024
- First submitted
- 9 Jul 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study to Evaluate the Effect of the Type of Conduit-duct Anastomosis Using the Single/continuous Suture Technique on the Postoperative Course in Patients Undergoing Liver Transplantation from a Deceased Donor.
- ClinicalTrials.gov ID
- NCT06533592
- Acronym / sponsor ID
- 2023/ABM/01/00017
- Conditions
- Liver Transplant; Complications, Bile Duct; Stricture, Postoperative, Bile Leak, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 28 Sep 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 1 Aug 2024 (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.
The main objective of the trial is to compare the effect of two end-to-end duct-to-duct anastomosis surgical techniques using the continuous suture method versus interrupted method (control group) on reducing the risk of bile leakages in the 90-day follow-up period after liver transplantation and other postoperative complications resulting from them i.e.: the occurrence of a critical stenosis in the duct-to-duct anastomosis within 90 days. In addition, as part of the research experiment, long-term biliary complications will be assessed, i.e. occurring over a period of more than 90 days (a 2-year observation period of patients was assumed).
As part of the trial 284 patients qualified for the procedure of liver transplantation from a deceased donor will be included, in whom end-to-end anastomosis of the bile ducts will be performed. After entering the study, patients will be randomized to one of the groups. In the group of 142 patients, duct-to-duct anastomosis will be performed using an interrupted suture (control group), and the remaining patients will be performed using the continuous suture technique.
The analysis will also include surgical complications, complications related to early and late graft function, retransplantation and overall survival.
Additionally the analyses an analysis of the impact of the occurrence of a biliary complication on the quality of life of patients after liver transplantation will be performed on the basis of the EORTC QLQ-C30 forms.
The period of observation of the patient after the procedure is planned for 24 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous suture technique | Experimental | Procedure: Continous suture techniqueBiliary duct-to-duct anastomosis performed with continous suture technique |
| Interrupted suture | Active comparator | Procedure: Interrupted suture techniqueBiliary duct-to-duct anastomosis performed with interrupted suture technique - control group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age over 18
- elective liver transplantation
- informed consent to participate in the study
- recipient bile duct diameter over 3mm
- donor bile duct diameter over 3mm
Key exclusion criteria (10 listed)
- age below 18
- pregnancy
- living donor liver transplantation
- split-liver or reduced-size liver transplantation
- liver transplantation other than from brain death donor
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 |
|---|---|---|
| Continous suture techniqueDuct-to-duct anastomosis will be performed using continuous suture technique for study group | Procedure or surgery | Continuous suture technique |
| Interrupted suture techniqueDuct-to-duct anastomosis will be performed using an interrupted suture for control group, | Procedure or surgery | Interrupted suture |
Primary outcome
Bile leakage
Time frame: 90 days post transplantation
Defined as bilirubin concentration in the drain fluid at least 3 times the serum bilirubin concentration or as the need for radiologic or operative intervention resulting from biliary collections or bile peritonitis up to 90 days post transplantation
6 secondary outcomes
Critical biliary stricture
Time frame: 90 days post transplantation
Other surgical complications
Time frame: 90 days post transplantation
Long-term biliary complications
Time frame: 2 years post transplantation
Overall survival
Time frame: 2 years post transplantation
Overall graft survival
Time frame: 2 years post transplantation
Impact of the occurrence of a biliary complication on the quality of life of patients
Time frame: 2 years post transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continous suture technique and Interrupted suture technique in people with Liver Transplant; Complications and Bile Duct; Stricture, Postoperative, run by Medical University of Warsaw at 1 site in Poland.
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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 24 Oct 2024. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Krzysztof Dudek, MD, PhD (+48 225992542, krzysztof.dudek@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bile leakage (time frame: 90 days post transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Oct 2024.