Liver TransplantNCT03636321
Stented Biliary Anastomosis in Living Donor Liver Transplantation
A study testing living donor liver transplantation with internal biliary stent in people with Liver Transplant, run by Alaa Mstafa Hassan Sewefy at 1 site in Egypt.
Trial summary
Determination of biliary complications in stented group compared to duct to duct anastomosis without stent Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Liver Transplant
- What is being tested?
- living donor liver transplantation with internal biliary stent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2018to 10 Nov 2019
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- adult patients eligible for a liver transplantation
- patients' written informed consent signed.
Who cannot join
- biliary reconstruction requires a hepatico-jejunostomy for anatomical/biliary disease reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Clinical Trial Of Stented Versus Stentless Biliary Anastomosis In Living Donor Liver Transplantation
Determination of biliary complications in stented group compared to duct to duct anastomosis without stent
Read the detailed description
30 patients included in the study. patients will be randomly allocated in two equal groups. In group A anastomosis will be done on intraductal stent and in group B anastomosis done without stent .the patients will be followed for one year to compare the result of two groups as regard biliary complications.
- Conditions
- Liver Transplant
- Being tested
- living donor liver transplantation with internal biliary stent
- Keywords
- living donor liver transplantation, intraductal stent, biliary complications after liver transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
living donor liver transplantation with internal biliary stentProcedure or surgery
living donor liver transplantation without internal biliary stent
| Study group | Role | What they receive |
|---|---|---|
| intraductal stent | Experimental | in this group ,patients candidate for living donor liver transplantation duct to duct biliary anastomosis with internal biliary stent Receives: Procedure: living donor liver transplantation with internal biliary stent |
| stentless | Active comparator | in this group ,patients candidate for living donor liver transplantation duct to duct biliary anastomosis will done without internal biliary Receives: Procedure: living donor liver transplantation with internal biliary stent |
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 (5)
biliary complications
types of biliary complications
Measured: one year
biliary related mortality
mortality
Measured: one year
rate of cholangitis
rate of cholangitis
Measured: 3 months
hospital stay
hospital stay
Measured: one month
time 2 biliary complications
time 2 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 posted17 Aug 2018
- Study start10 Aug 2018
- Primary completion10 Nov 2019
- Study completion10 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaa Mstafa Hassan Sewefy
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Sponsor-investigator, Alaa Mstafa Hassan Sewefy, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636321
- Sponsor's protocol ID
- AS.fac.med.55
- Status last verified
- May 2020
- First submitted
- 2 Aug 2018
- Last updated
- 18 May 2020
- Results posted
- No
- 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 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trial Of Stented Versus Stentless Biliary Anastomosis In Living Donor Liver Transplantation
- ClinicalTrials.gov ID
- NCT03636321
- Acronym / sponsor ID
- AS.fac.med.55
- Conditions
- Liver Transplant
- Keywords
- living donor liver transplantation, intraductal stent, biliary complications after liver transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alaa Mstafa Hassan SewefyUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 10 Nov 2019 (actual)
- Study completion
- 10 Nov 2019 (actual)
- First posted
- 17 Aug 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.
Determination of biliary complications in stented group compared to duct to duct anastomosis without stent
Detailed description
30 patients included in the study. patients will be randomly allocated in two equal groups. In group A anastomosis will be done on intraductal stent and in group B anastomosis done without stent .the patients will be followed for one year to compare the result of two groups as regard biliary complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intraductal stent | Experimental | Procedure: living donor liver transplantation with internal biliary stentin this group ,patients candidate for living donor liver transplantation duct to duct biliary anastomosis with internal biliary stent |
| stentless | Active comparator | Procedure: living donor liver transplantation with internal biliary stentin this group ,patients candidate for living donor liver transplantation duct to duct biliary anastomosis will done without internal biliary |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- adult patients eligible for a liver transplantation
- patients' written informed consent signed.
Key exclusion criteria (1 listed)
- biliary reconstruction requires a hepatico-jejunostomy for anatomical/biliary disease reason.
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 |
|---|---|---|
| living donor liver transplantation with internal biliary stentliving donor liver transplantation without internal biliary stent | Procedure or surgery | intraductal stent, stentless |
Primary outcome
biliary complications after living donor liver transplantation
Time frame: one year
incidence of biliary complications after living donor liver transplantation
5 secondary outcomes
biliary complications
Time frame: one year
biliary related mortality
Time frame: one year
rate of cholangitis
Time frame: 3 months
hospital stay
Time frame: one month
time 2 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 May 2020.
- 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. 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 living donor liver transplantation with internal biliary stent in people with Liver Transplant, run by Alaa Mstafa Hassan Sewefy at 1 site in Egypt.
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 2 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 May 2020. 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 Egypt. 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?
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 May 2020.