Living Donor Liver TransplantationPhase 3NCT01907750
Transcystic Versus Transanastomotic Tube Drainage in Right Lobe LDLT
A Phase 3 study testing biliary drainage tube in people with Living Donor Liver Transplantation, run by Mansoura University at 1 site in Egypt.
Trial summary
To evaluate the safety and effectiveness of the use of transcystic biliary drainage tube (not transanastomotic) in comparison to the usual transanastomotic biliary drainage tube. Read more about this study
- Who is it for?
- Ages 2 to 70 years
- Conditions the study is for
- Living Donor Liver Transplantation
- What is being tested?
- biliary drainage tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2009to Jun 2016
- Phase
- Phase 3
- 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 2 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- living donor liver transplantation
- single bile duct in the graft
Who cannot join
- multiple bile ducts
Trial locations and contacts
1 site in 1 country.
Tarek Salah contact
Egypt1 site, 1 recruiting
- Recruiting
Gastro-enterolgy surgical center, Mansoura University
Al Mansurah, Al-Dakahleia, 35516
ahmad M Sultan, MD, +201003886838, dr_ahmadsultan@hotmail.com
Ahmad M Sultan, MD
About this study
Official title: Transcystic Versus Transanastomotic Biliary Drainage Tubes in Living Donor Liver Transplantation. A Prospective Randomized Trial.
To evaluate the safety and effectiveness of the use of transcystic biliary drainage tube (not transanastomotic) in comparison to the usual transanastomotic biliary drainage tube.
Read the detailed description
a biliary drainage tube is usually inserted into the biliary passage after choledocho-choledochostomy (bile duct to bile duct joining).
A 4F or 5F biliary catheter (Marquat Genie biomedical, france) is used in all cases.
the study is to compare the effectiveness and safety of 2 different placement techniques:
- the usual trans-anastomotic position (the tube is placed across the anastomosis line with the tip inside the intrahepatic biliary branches) through an opening in the wall of the recipient's common bile duct
- a transcystic non-anastomotic position (the tube is placed through the cystic duct opening into the distal common bile duct not passing through anastomosis)
- Conditions
- Living Donor Liver Transplantation
- Being tested
- biliary drainage tube
- Keywords
- biliary fistula, biliary stricture, biliary drainage tube
- Medical subject headings
- Biliary Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biliary drainage tubeDevice
| Study group | Role | What they receive |
|---|---|---|
| Transanastomotic tube | Active comparator | use of transanastomotic tube. Receives: Device: biliary drainage tube |
| Transcystic tube | Active comparator | use of transcystic tube to drain bile duct Receives: Device: biliary drainage tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
early postoperative biliary fistula
Measured: 2 weeks
Secondary outcomes (1)
biliary stricture
Measured: 2 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startJan 2009
- Primary completionMar 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Living Donor Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Mohammad Ahmad Sultan, Mansoura University
- Investigators
- Ahmad M Sultan, MD, PhD, Principal investigator, Gastro-enterology surgical center, Mansoura UniversityMohammed Abdul-Wahab, MD, PhD, Study chair, Gastro-enterolgy surgical center, Mansoura UniversityTarek Salah, MD, PhD, Study director, Gastro-enterolgy surgical center, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907750
- Sponsor's protocol ID
- Biliary_TCvsTA
- Status last verified
- Feb 2016
- First submitted
- 23 Jun 2013
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcystic Versus Transanastomotic Biliary Drainage Tubes in Living Donor Liver Transplantation. A Prospective Randomized Trial.
- ClinicalTrials.gov ID
- NCT01907750
- Acronym / sponsor ID
- Biliary_TCvsTA
- Conditions
- Living Donor Liver Transplantation
- Keywords
- biliary fistula, biliary stricture, biliary drainage tube
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 25 Jul 2013 (estimated)
- 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.
To evaluate the safety and effectiveness of the use of transcystic biliary drainage tube (not transanastomotic) in comparison to the usual transanastomotic biliary drainage tube.
Detailed description
a biliary drainage tube is usually inserted into the biliary passage after choledocho-choledochostomy (bile duct to bile duct joining).
A 4F or 5F biliary catheter (Marquat Genie biomedical, france) is used in all cases.
the study is to compare the effectiveness and safety of 2 different placement techniques:
- the usual trans-anastomotic position (the tube is placed across the anastomosis line with the tip inside the intrahepatic biliary branches) through an opening in the wall of the recipient's common bile duct
- a transcystic non-anastomotic position (the tube is placed through the cystic duct opening into the distal common bile duct not passing through anastomosis)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transanastomotic tube | Active comparator | Device: biliary drainage tubeuse of transanastomotic tube. |
| Transcystic tube | Active comparator | Device: biliary drainage tubeuse of transcystic tube to drain bile duct |
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- living donor liver transplantation
- single bile duct in the graft
Key exclusion criteria (1 listed)
- multiple bile ducts
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 |
|---|---|---|
| biliary drainage tube | Device | Transanastomotic tube, Transcystic tube |
Primary outcome
early postoperative biliary fistula
Time frame: 2 weeks
1 secondary outcome
biliary stricture
Time frame: 2 years postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2016.
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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.
Tarek Salah contact
Ahmad M Sultan, MD, PhD principal investigator
Gastro-enterology surgical center, Mansoura University
Mohammed Abdul-Wahab, MD, PhD study chair
Gastro-enterolgy surgical center, Mansoura University
Tarek Salah, MD, PhD study director
Gastro-enterolgy surgical center, Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing biliary drainage tube in people with Living Donor Liver Transplantation, run by Mansoura University 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: status not confirmed, as of the sponsor's last update on 1 Mar 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmad M Sultan (+201003886838, dr_ahmadsultan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early postoperative biliary fistula (time frame: 2 weeks). 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 1 Mar 2016.