Biliary StrictureNCT03673033
Biliary Complications in Live Donor Liver Transplantation
An observational study of Biliary Stricture and Bile Duct Stenosi, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The study was designed as a prospective cohort study. The effects of hot and cold ischemic times during live donor liver transplantation on postoperative 1-3 and 6 month follow up biliary complications will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Stricture, Bile Duct Stenosi, Bile Leak
- What is being tested?
- liver transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2018to 3 Aug 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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
Study population: Adult patients with live donor liver transplant for any reason
Who may be able to join
- Live donor liver transplantation Emergency Live donor liver transplantation Multiple or single bile duct anastomosis in liver transplantation
Who cannot join
- Hepaticojejunostomy Cadaveric liver transplantation Pediatric liver transplantation Cmv infection presence Hepatic arterial thrombus Porta thrombus Acute rejection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can the Effects of Cold and Hot Ischemia Time on Biliary Complications in Live Donor Liver Transplantation Be Classified?
The study was designed as a prospective cohort study. The effects of hot and cold ischemic times during live donor liver transplantation on postoperative 1-3 and 6 month follow up biliary complications will be investigated.
Read the detailed description
The invastigators will record the age, gender, weight, diagnosis, presence of hcc (hepatocellular carcinoma), whether transcatheter embolization (transarterial radiolabelization) is performed, meld score, age of donor, gender, graft hepatic artery diameter, bile duct diameter and number before surgery.
During the operation,
The duration of ischemia will be evaluated as three stages.
During the first stage donor hepatectomy, the time from the interruption of the hepatic artery to the first administration of the solution to the bile ducts on the back table will be recorded and recorded as the first ischemia time.
The time from the administration of the solution to the biliary system on the stage 2 back-to-back table until the cold anastomosis is performed will be recorded as the duration of cold ischemia.
The time from the third graft to receipt of the graft to the end of the hepatic artery anastomosis will be recorded as the second ischemia time.
The duration of operation, whether or not pringle maneuvers were performed, hepatic artery thrombus, graft bile number, number of bile anastomoses, lowest biliary tract diameter and hepatic artery diameter
After the surgery,
The use of immunosuppression (Tacrolimus, certican or combined use) will be recorded.
During the follow-up period of 1,3,6 months, complaints of the patients, laboratory values and imaging methods as well as whether or not there is biliary complication (leakage, stenosis) will be recorded.
If the complication develops during follow-up, the procedure (follow-up, ercp, ptk, surgery) will be recorded.
Since the study is observational, normal treatment will not be involved.
Participants will not be included in the study in the presence of hepaticojejunostomy patients, cadaveric transplant patients, pediatric transplant patients, Cmv infection, hepatic artery thrombosis, portal thrombosis, acute rejection in the first operation.
Participants with live donor liver transplant patients, multiple gallbladder anastomoses or single bile duct multiple anastomoses will be included.
When the power analysis for the study was taken as α = 0.05 and 1-β (power) = 0,80, it was calculated that at least 99 patients should be taken to have a difference of 38% in the rates of biliary complication in cold ischemia.
The demographic and all findings of the disease will be collected at excell and at the end of the study all the findings will be statistically evaluated and the results will be evaluated.
- Conditions
- Biliary Stricture, Bile Duct Stenosi, Bile Leak, Bile Duct Injury
- Being tested
- liver transplantation
- Keywords
- Transplantation, Hepatic, Cirrhosis, Bile duct
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver transplantationProcedure or surgery
calculation of hot and cold ischemia durations from donor artery cut-off time in liver transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
development of biliary complication in the first month after liver transplantation
biliary complication at the first month after transplantation and whether this complication is interfered with or not will be evaluated.
Measured: 1 month
Secondary outcomes (2)
development of biliary complication in the three months after liver transplantation
biliary complication at the third month after transplantation and whether this complication is interfered with or not will be evaluated.
Measured: 3 months
development of biliary complication in the six month after liver transplantation
biliary complication at the sixth month after transplantation and whether this complication is interfered with or not will be evaluated.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start10 Mar 2018
- Primary completion30 Jul 2019
- Study completion3 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary StrictureStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, cihan gokler, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673033
- Sponsor's protocol ID
- 2018/18
- Status last verified
- Sep 2018
- First submitted
- 13 Sep 2018
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: de-identified individual participant data for all primary, secondary and tertiary outcome measures will be made available
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Effects of Cold and Hot Ischemia Time on Biliary Complications in Live Donor Liver Transplantation Be Classified?
- ClinicalTrials.gov ID
- NCT03673033
- Acronym / sponsor ID
- 2018/18
- Conditions
- Biliary Stricture, Bile Duct Stenosi, Bile Leak, Bile Duct Injury
- Keywords
- Transplantation, Hepatic, Cirrhosis, Bile duct
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 10 Mar 2018 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 3 Aug 2019 (actual)
- First posted
- 17 Sep 2018 (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 study was designed as a prospective cohort study. The effects of hot and cold ischemic times during live donor liver transplantation on postoperative 1-3 and 6 month follow up biliary complications will be investigated.
Detailed description
The invastigators will record the age, gender, weight, diagnosis, presence of hcc (hepatocellular carcinoma), whether transcatheter embolization (transarterial radiolabelization) is performed, meld score, age of donor, gender, graft hepatic artery diameter, bile duct diameter and number before surgery.
During the operation,
The duration of ischemia will be evaluated as three stages.
During the first stage donor hepatectomy, the time from the interruption of the hepatic artery to the first administration of the solution to the bile ducts on the back table will be recorded and recorded as the first ischemia time.
The time from the administration of the solution to the biliary system on the stage 2 back-to-back table until the cold anastomosis is performed will be recorded as the duration of cold ischemia.
The time from the third graft to receipt of the graft to the end of the hepatic artery anastomosis will be recorded as the second ischemia time.
The duration of operation, whether or not pringle maneuvers were performed, hepatic artery thrombus, graft bile number, number of bile anastomoses, lowest biliary tract diameter and hepatic artery diameter
After the surgery,
The use of immunosuppression (Tacrolimus, certican or combined use) will be recorded.
During the follow-up period of 1,3,6 months, complaints of the patients, laboratory values and imaging methods as well as whether or not there is biliary complication (leakage, stenosis) will be recorded.
If the complication develops during follow-up, the procedure (follow-up, ercp, ptk, surgery) will be recorded.
Since the study is observational, normal treatment will not be involved.
Participants will not be included in the study in the presence of hepaticojejunostomy patients, cadaveric transplant patients, pediatric transplant patients, Cmv infection, hepatic artery thrombosis, portal thrombosis, acute rejection in the first operation.
Participants with live donor liver transplant patients, multiple gallbladder anastomoses or single bile duct multiple anastomoses will be included.
When the power analysis for the study was taken as α = 0.05 and 1-β (power) = 0,80, it was calculated that at least 99 patients should be taken to have a difference of 38% in the rates of biliary complication in cold ischemia.
The demographic and all findings of the disease will be collected at excell and at the end of the study all the findings will be statistically evaluated and the results will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with live donor liver transplant for any reason
Key inclusion criteria (1 listed)
- Live donor liver transplantation Emergency Live donor liver transplantation Multiple or single bile duct anastomosis in liver transplantation
Key exclusion criteria (1 listed)
- Hepaticojejunostomy Cadaveric liver transplantation Pediatric liver transplantation Cmv infection presence Hepatic arterial thrombus Porta thrombus Acute rejection
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 |
|---|---|---|
| liver transplantationcalculation of hot and cold ischemia durations from donor artery cut-off time in liver transplantation | Procedure or surgery | – |
Primary outcome
development of biliary complication in the first month after liver transplantation
Time frame: 1 month
biliary complication at the first month after transplantation and whether this complication is interfered with or not will be evaluated.
2 secondary outcomes
development of biliary complication in the three months after liver transplantation
Time frame: 3 months
development of biliary complication in the six month after liver transplantation
Time frame: 6 months
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 3 Oct 2019.
- Individual participant dataSharing planned: Yes. de-identified individual participant data for all primary, secondary and tertiary outcome measures will be made available
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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?
An observational study of Biliary Stricture and Bile Duct Stenosi, run by Inonu University 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 3 Oct 2019. 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?
development of biliary complication in the first month after liver transplantation (time frame: 1 month). 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 3 Oct 2019.