Transplantation, LiverBILIDRAINTNCT02356939
Removable Intraductal Stenting in Duct-to-duct Biliary Reconstruction in Liver Transplantation
A study testing intraductal removable stent custom-made segment (2 cm) and stent extraction by ERCP in people with Transplantation, Liver, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Randomized controlled trial including 7 French transplantation centers. Pre-inclusion of the patients is made when enlisted for liver transplantation (LT). Definitive inclusion and randomization is performed during LT, for patients undergoing a duct-to-duct biliary anastomosis with a graft bile duct diameter smaller… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplantation, Liver
- What is being tested?
- intraductal removable stent custom-made segment (2 cm) and stent extraction by ERCP
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 493 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2015to 22 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for a liver transplantation
- Patients' written informed consent signed
- Patient with social coverage (excepting AME)
Who cannot join
- Biliary reconstruction decided to be a hepaticojejunostomy for anatomical/biliary disease reason
- Non eligibility for liver transplantation:
- - Uncontrolled infectious process
- - Incompatible physical or mental state with the observance of the immunosuppressive drugs
- - Cardiopulmonary comorbidities severe / uncontrolled
- - Active alcohol intoxication or addiction
Show all 9Show fewer
- - Pregnant or breastfeeding women (pregnancy test will be performed at baseline)
- Latex Allergy, polymer or rubber
- Patient participating in another interventional study about biliary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Of A Removable Intraductal Stent In Duct-To-Duct Biliary Reconstruction To Prevent Biliary Complications In Liver Transplantation: A Randomized Controlled Trial
Randomized controlled trial including 7 French transplantation centers. Pre-inclusion of the patients is made when enlisted for liver transplantation (LT). Definitive inclusion and randomization is performed during LT, for patients undergoing a duct-to-duct biliary anastomosis with a graft bile duct diameter smaller than 7mm. In the intraductal stent tube group, a custom-made segment of a T-tube is placed into the bile duct, and removed endoscopically four to six months postoperative. The surgical technique is available on a movie during randomization on the website. The primary endpoint is the occurrence of biliary complications, including biliary fistulae and strictures, during six months of follow-up. Secondary evaluation criteria are the incidence of complications related to the stent placement and its extraction by endoscopy.
Discussion: Biliary complications following LT are significant causes of morbidity, retransplantation and eventually mortality. Although controversial, the use of a T-tube has been proven to be useless and even responsible for specific complications in many studies, including several randomized trials. However, several studies have identified a small bile duct diameter as a risk factor for biliary stenosis. A threshold of 7mm was found to be significantly associated to biliary stenosis. Our team published a preliminary study including 20 patients using a new technique of intraductal stenting. Only 4 complications were reported in the overall study population while no biliary complication occurred in the subgroup of patients who received a whole graft LT. Moreover, no technical failure and no procedure-related complications were noted before and during drain removal. Although intraductal stent tube in duct-to duct biliary anastomosis seems feasible and safe, a multicentric randomized controlled study is needed to validate it as a protective tool for biliary complications following LT.
Read the detailed description
Comparative, multicentric, prospective, randomized non-blinded, two-groups study.
The follow-up is set at six months postoperative for a good screening of the majority of biliary complications.
The inclusion period is set at 3.5 years, for total study duration of 4 years. The patients' inclusion will be made in 7 liver transplantation centers in France.
Patients' inclusion will be performed in consultation at the moment of enlistment for LT, where they will be informed of the content, the benefits and risks of the study, and have to sign a written consent.
Definitive inclusion will be performed in operating room, during LT, and depends on fulfilling of the following "definitive inclusion criteria" (see above).
The randomization will be performed in operating room by the investigator and coordinated by the Clinical Research Unit of promoters' center (Saint Antoine Hospital, Paris), with a specific software accessible on the Internet.
In the IST group, the surgeon will place the IST in the bile duct, which is a custom-made segment (2 cm) of a 8 French T-tube with no side holes. The stent is inserted in the biliary duct without suture fixation.
In order to minimize bias and to homogenize the technique, a short technical explanatory movie will be realized by the promoter's team and distributed in each center.
Each center will perform its habitual postoperative follow up. Clinical, biological, and radiological exhaustive data will be collected at Day 1, Day 7, Day 15, Month 1, Month 3, Month 6.
A Magnetic Resonance Cholangiography (MRC) will be systematically performed at six months post LT.
In the IST group, an endoscopic retrograde cholangio-pancreatography (ERCP) with sphincterotomy will be planned between the 4th and the 5th month post-transplantation, requiring a short stay in hospital, a general anesthesia, clinical and biological tests including plasmatic lipase dosage at Day 1.
Every undesirable event will be immediately reported to the promoter for further investigation within its severity. Severe undesirable events will be previously defined.
- Conditions
- Transplantation, Liver
- Being tested
- intraductal removable stent custom-made segment (2 cm), stent extraction by ERCP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraductal removable stent custom-made segment (2 cm)Device
: In the IST group, the surgeon will place the IST in the bile duct, which is a custom-made segment (2 cm) of a 8 French T-tube. The stent is inserted in the biliary duct without suture fixation.
In order to minimize bias and to homogenize the technique, a short technical explanatory movie was realized by the promoter's team and edited on internet.
In the IST group, an endoscopic retrograde cholangio-pancreatography (ERCP) with sphincterotomy will be planned between the 4th and the 5th month post-transplantation, requiring a short stay in hospital, a general anesthesia, clinical and biological tests including plasmatic lipase dosage at Day 1.
stent extraction by ERCPProcedure or surgery
stent extraction by endoscopic retrograde cholangio-pancreatography
| Study group | Role | What they receive |
|---|---|---|
| Intraductal stent (IST) | Experimental | For intervention : intraductal removable stent In the IST group, the surgeon will place the IST in the bile duct, which is a custom-made segment (2 cm) of a 8 French T-tube. The stent is inserted in the biliary duct without suture fixation.
In the IST group, an endoscopic retrograde cholangio-pancreatography (ERCP) with sphincterotomy will be planned between the 4th and the 6th month post-transplantation. Receives: Device: intraductal removable stent custom-made segment (2 cm) |
| Without intraductal stent (no IST) | Experimental | For intervention : stent extraction by endoscopic retrograde cholangio-pancreatography (ERCP) Each center will perform its habitual postoperative follow up. Receives: Procedure: stent extraction by ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of biliary strictures and biliary fistulae within six months post-transplantation.
A biliary leakage is defined by the presence of bile in the abdominal drainage, and/or an intra-abdominal collection with bilious content requiring drainage.
A biliary stenosis is defined by a size discrepancy between the two sides of the bile duct anastomosis on specific imaging (MR cholangiography, ERCP), associated to an upstream bile tract distention, with a clinical and biological cholestasis, after excluding other cholestasis causes (rejection, viral reactivation).
Measured: 6 months
Secondary outcomes (3)
Incidence of specific complications related to the IST and its extraction by endoscopy
Secondary endpoints are the incidence of specific complications related to the IST and its extraction by endoscopy: cholangitis, stent migration, extraction difficulties, acute pancreatitis, digestive perforation, hemorrhage.
Measured: 6 months
Graft survival
Incidence of graft loss, i.e. retransplantation rate
Measured: 6 months
Patient survival
Incidence of patient death
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 posted6 Feb 2015 (estimated)
- Study start3 Apr 2015
- Primary completion22 May 2019
- Study completion22 May 2019
Why it stopped: Interruption of the study for safety reasons at the decision of the sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Transplantation, LiverStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 493 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier SCATTON, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de ParisOlivier SOUBRANE, PU-PH, Study director, Assistance Publique - Hôpitaux de ParisClaire GOUMARD, MD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356939
- Sponsor's protocol ID
- P 130919
- Acronym
- BILIDRAINT
- Status last verified
- Oct 2021
- First submitted
- 2 Feb 2015
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
National Institutes of Health Consensus Development Conference Statement: liver transplantation--June 20-23, 1983. Hepatology. 1984 Jan-Feb;4(1 Suppl):107S-110S. No abstract available.
PubMed 6363254Consensus conference: Indications for Liver Transplantation, January 19 and 20, 2005, Lyon-Palais Des Congres: text of recommendations (long version). Liver Transpl. 2006 Jun;12(6):998-1011. doi: 10.1002/lt.20765. No abstract available.
PubMed 16721776Neuhaus P, Blumhardt G, Bechstein WO, Steffen R, Platz KP, Keck H. Technique and results of biliary reconstruction using side-to-side choledochocholedochostomy in 300 orthotopic liver transplants. Ann Surg. 1994 Apr;219(4):426-34. doi: 10.1097/00000658-199404000-00014.
PubMed 8161269Akamatsu N, Sugawara Y, Hashimoto D. Biliary reconstruction, its complications and management of biliary complications after adult liver transplantation: a systematic review of the incidence, risk factors and outcome. Transpl Int. 2011 Apr;24(4):379-92. doi: 10.1111/j.1432-2277.2010.01202.x. Epub 2010 Dec 10.
PubMed 21143651Roberts MS, Angus DC, Bryce CL, Valenta Z, Weissfeld L. Survival after liver transplantation in the United States: a disease-specific analysis of the UNOS database. Liver Transpl. 2004 Jul;10(7):886-97. doi: 10.1002/lt.20137.
PubMed 15237373Jain A, Reyes J, Kashyap R, Dodson SF, Demetris AJ, Ruppert K, Abu-Elmagd K, Marsh W, Madariaga J, Mazariegos G, Geller D, Bonham CA, Gayowski T, Cacciarelli T, Fontes P, Starzl TE, Fung JJ. Long-term survival after liver transplantation in 4,000 consecutive patients at a single center. Ann Surg. 2000 Oct;232(4):490-500. doi: 10.1097/00000658-200010000-00004.
PubMed 10998647Sharma S, Gurakar A, Jabbour N. Biliary strictures following liver transplantation: past, present and preventive strategies. Liver Transpl. 2008 Jun;14(6):759-69. doi: 10.1002/lt.21509.
PubMed 18508368Duailibi DF, Ribeiro MA Jr. Biliary complications following deceased and living donor liver transplantation: a review. Transplant Proc. 2010 Mar;42(2):517-20. doi: 10.1016/j.transproceed.2010.01.017.
PubMed 20304182Park JB, Kwon CH, Choi GS, Chun JM, Jung GO, Kim SJ, Joh JW, Lee SK. Prolonged cold ischemic time is a risk factor for biliary strictures in duct-to-duct biliary reconstruction in living donor liver transplantation. Transplantation. 2008 Dec 15;86(11):1536-42. doi: 10.1097/TP.0b013e31818b2316.
PubMed 19077886Marubashi S, Dono K, Nagano H, Kobayashi S, Takeda Y, Umeshita K, Monden M, Doki Y, Mori M. Biliary reconstruction in living donor liver transplantation: technical invention and risk factor analysis for anastomotic stricture. Transplantation. 2009 Nov 15;88(9):1123-30. doi: 10.1097/TP.0b013e3181ba184a.
PubMed 19898209Hwang S, Lee SG, Sung KB, Park KM, Kim KH, Ahn CS, Lee YJ, Lee SK, Hwang GS, Moon DB, Ha TY, Kim DS, Jung JP, Song GW. Long-term incidence, risk factors, and management of biliary complications after adult living donor liver transplantation. Liver Transpl. 2006 May;12(5):831-8. doi: 10.1002/lt.20693.
PubMed 16528711Shaked A. Use of T tube in liver transplantation. Liver Transpl Surg. 1997 Sep;3(5 Suppl 1):S22-3. No abstract available.
PubMed 9377769Rolles K, Dawson K, Novell R, Hayter B, Davidson B, Burroughs A. Biliary anastomosis after liver transplantation does not benefit from T tube splintage. Transplantation. 1994 Feb;57(3):402-4. doi: 10.1097/00007890-199402150-00015.
PubMed 8108875Ben-Ari Z, Neville L, Davidson B, Rolles K, Burroughs AK. Infection rates with and without T-tube splintage of common bile duct anastomosis in liver transplantation. Transpl Int. 1998;11(2):123-6. doi: 10.1007/s001470050115.
PubMed 9561678Vougas V, Rela M, Gane E, Muiesan P, Melendez HV, Williams R, Heaton ND. A prospective randomised trial of bile duct reconstruction at liver transplantation: T tube or no T tube? Transpl Int. 1996;9(4):392-5. doi: 10.1007/BF00335701.
PubMed 8819276
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of A Removable Intraductal Stent In Duct-To-Duct Biliary Reconstruction To Prevent Biliary Complications In Liver Transplantation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02356939
- Acronym / sponsor ID
- BILIDRAINT / P 130919
- Conditions
- Transplantation, Liver
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interruption of the study for safety reasons at the decision of the sponsor
- Enrolment
- 493 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 3 Apr 2015 (actual)
- Primary completion
- 22 May 2019 (actual)
- Study completion
- 22 May 2019 (actual)
- First posted
- 6 Feb 2015 (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.
Randomized controlled trial including 7 French transplantation centers. Pre-inclusion of the patients is made when enlisted for liver transplantation (LT). Definitive inclusion and randomization is performed during LT, for patients undergoing a duct-to-duct biliary anastomosis with a graft bile duct diameter smaller than 7mm. In the intraductal stent tube group, a custom-made segment of a T-tube is placed into the bile duct, and removed endoscopically four to six months postoperative. The surgical technique is available on a movie during randomization on the website. The primary endpoint is the occurrence of biliary complications, including biliary fistulae and strictures, during six months of follow-up. Secondary evaluation criteria are the incidence of complications related to the stent placement and its extraction by endoscopy.
Discussion: Biliary complications following LT are significant causes of morbidity, retransplantation and eventually mortality. Although controversial, the use of a T-tube has been proven to be useless and even responsible for specific complications in many studies, including several randomized trials. However, several studies have identified a small bile duct diameter as a risk factor for biliary stenosis. A threshold of 7mm was found to be significantly associated to biliary stenosis. Our team published a preliminary study including 20 patients using a new technique of intraductal stenting. Only 4 complications were reported in the overall study population while no biliary complication occurred in the subgroup of patients who received a whole graft LT. Moreover, no technical failure and no procedure-related complications were noted before and during drain removal. Although intraductal stent tube in duct-to duct biliary anastomosis seems feasible and safe, a multicentric randomized controlled study is needed to validate it as a protective tool for biliary complications following LT.
Detailed description
Comparative, multicentric, prospective, randomized non-blinded, two-groups study.
The follow-up is set at six months postoperative for a good screening of the majority of biliary complications.
The inclusion period is set at 3.5 years, for total study duration of 4 years. The patients' inclusion will be made in 7 liver transplantation centers in France.
Patients' inclusion will be performed in consultation at the moment of enlistment for LT, where they will be informed of the content, the benefits and risks of the study, and have to sign a written consent.
Definitive inclusion will be performed in operating room, during LT, and depends on fulfilling of the following "definitive inclusion criteria" (see above).
The randomization will be performed in operating room by the investigator and coordinated by the Clinical Research Unit of promoters' center (Saint Antoine Hospital, Paris), with a specific software accessible on the Internet.
In the IST group, the surgeon will place the IST in the bile duct, which is a custom-made segment (2 cm) of a 8 French T-tube with no side holes. The stent is inserted in the biliary duct without suture fixation.
In order to minimize bias and to homogenize the technique, a short technical explanatory movie will be realized by the promoter's team and distributed in each center.
Each center will perform its habitual postoperative follow up. Clinical, biological, and radiological exhaustive data will be collected at Day 1, Day 7, Day 15, Month 1, Month 3, Month 6.
A Magnetic Resonance Cholangiography (MRC) will be systematically performed at six months post LT.
In the IST group, an endoscopic retrograde cholangio-pancreatography (ERCP) with sphincterotomy will be planned between the 4th and the 5th month post-transplantation, requiring a short stay in hospital, a general anesthesia, clinical and biological tests including plasmatic lipase dosage at Day 1.
Every undesirable event will be immediately reported to the promoter for further investigation within its severity. Severe undesirable events will be previously defined.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraductal stent (IST) | Experimental | Device: intraductal removable stent custom-made segment (2 cm)For intervention : intraductal removable stent In the IST group, the surgeon will place the IST in the bile duct, which is a custom-made segment (2 cm) of a 8 French T-tube. The stent is inserted in the biliary duct without suture fixation. In the IST group, an endoscopic retrograde cholangio-pancreatography (ERCP) with sphincterotomy will be planned between the 4th and the 6th month post-transplantation. |
| Without intraductal stent (no IST) | Experimental | Procedure: stent extraction by ERCPFor intervention : stent extraction by endoscopic retrograde cholangio-pancreatography (ERCP) Each center will perform its habitual postoperative follow up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients eligible for a liver transplantation
- Patients' written informed consent signed
- Patient with social coverage (excepting AME)
Key exclusion criteria (9 listed)
- Biliary reconstruction decided to be a hepaticojejunostomy for anatomical/biliary disease reason
- Non eligibility for liver transplantation:
- Latex Allergy, polymer or rubber
- Patient participating in another interventional study about biliary disease
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 |
|---|---|---|
| intraductal removable stent custom-made segment (2 cm): In the IST group, the surgeon will place the IST in the bile duct, which is a custom-made segment (2 cm) of a 8 French T-tube. The stent is inserted in the biliary duct without suture fixation. In order to minimize bias and to homogenize the technique, a short technical explanatory movie was realized by the promoter's team and edited on internet. In the IST group, an endoscopic retrograde cholangio-pancreatography (ERCP) with sphincterotomy will be planned between the 4th and the 5th month post-transplantation, requiring a short stay in hospital, a general anesthesia, clinical and biological tests including plasmatic lipase dosage at Day 1. | Device | Intraductal stent (IST) |
| stent extraction by ERCPstent extraction by endoscopic retrograde cholangio-pancreatography | Procedure or surgery | Without intraductal stent (no IST) |
Primary outcome
Incidence of biliary strictures and biliary fistulae within six months post-transplantation.
Time frame: 6 months
A biliary leakage is defined by the presence of bile in the abdominal drainage, and/or an intra-abdominal collection with bilious content requiring drainage. A biliary stenosis is defined by a size discrepancy between the two sides of the bile duct anastomosis on specific imaging (MR cholangiography, ERCP), associated to an upstream bile tract distention, with a clinical and biological cholestasis, after excluding other cholestasis causes (rejection, viral reactivation).
3 secondary outcomes
Incidence of specific complications related to the IST and its extraction by endoscopy
Time frame: 6 months
Graft survival
Time frame: 6 months
Patient survival
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Interruption of the study for safety reasons at the decision of the sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Background: PubMed 6363254National Institutes of Health Consensus Development Conference Statement: liver transplantation--June 20-23, 1983. Hepatology. 1984 Jan-Feb;4(1 Suppl):107S-110S. No abstract available.
- Background: PubMed 16721776Consensus conference: Indications for Liver Transplantation, January 19 and 20, 2005, Lyon-Palais Des Congres: text of recommendations (long version). Liver Transpl. 2006 Jun;12(6):998-1011. doi: 10.1002/lt.20765. No abstract available.
- Background: PubMed 8161269Neuhaus P, Blumhardt G, Bechstein WO, Steffen R, Platz KP, Keck H. Technique and results of biliary reconstruction using side-to-side choledochocholedochostomy in 300 orthotopic liver transplants. Ann Surg. 1994 Apr;219(4):426-34. doi: 10.1097/00000658-199404000-00014.
- Background: PubMed 21143651Akamatsu N, Sugawara Y, Hashimoto D. Biliary reconstruction, its complications and management of biliary complications after adult liver transplantation: a systematic review of the incidence, risk factors and outcome. Transpl Int. 2011 Apr;24(4):379-92. doi: 10.1111/j.1432-2277.2010.01202.x. Epub 2010 Dec 10.
- Background: PubMed 15237373Roberts MS, Angus DC, Bryce CL, Valenta Z, Weissfeld L. Survival after liver transplantation in the United States: a disease-specific analysis of the UNOS database. Liver Transpl. 2004 Jul;10(7):886-97. doi: 10.1002/lt.20137.
- Background: PubMed 10998647Jain A, Reyes J, Kashyap R, Dodson SF, Demetris AJ, Ruppert K, Abu-Elmagd K, Marsh W, Madariaga J, Mazariegos G, Geller D, Bonham CA, Gayowski T, Cacciarelli T, Fontes P, Starzl TE, Fung JJ. Long-term survival after liver transplantation in 4,000 consecutive patients at a single center. Ann Surg. 2000 Oct;232(4):490-500. doi: 10.1097/00000658-200010000-00004.
- Background: PubMed 18508368Sharma S, Gurakar A, Jabbour N. Biliary strictures following liver transplantation: past, present and preventive strategies. Liver Transpl. 2008 Jun;14(6):759-69. doi: 10.1002/lt.21509.
- Background: PubMed 20304182Duailibi DF, Ribeiro MA Jr. Biliary complications following deceased and living donor liver transplantation: a review. Transplant Proc. 2010 Mar;42(2):517-20. doi: 10.1016/j.transproceed.2010.01.017.
- Background: PubMed 19077886Park JB, Kwon CH, Choi GS, Chun JM, Jung GO, Kim SJ, Joh JW, Lee SK. Prolonged cold ischemic time is a risk factor for biliary strictures in duct-to-duct biliary reconstruction in living donor liver transplantation. Transplantation. 2008 Dec 15;86(11):1536-42. doi: 10.1097/TP.0b013e31818b2316.
- Background: PubMed 19898209Marubashi S, Dono K, Nagano H, Kobayashi S, Takeda Y, Umeshita K, Monden M, Doki Y, Mori M. Biliary reconstruction in living donor liver transplantation: technical invention and risk factor analysis for anastomotic stricture. Transplantation. 2009 Nov 15;88(9):1123-30. doi: 10.1097/TP.0b013e3181ba184a.
- Background: PubMed 16528711Hwang S, Lee SG, Sung KB, Park KM, Kim KH, Ahn CS, Lee YJ, Lee SK, Hwang GS, Moon DB, Ha TY, Kim DS, Jung JP, Song GW. Long-term incidence, risk factors, and management of biliary complications after adult living donor liver transplantation. Liver Transpl. 2006 May;12(5):831-8. doi: 10.1002/lt.20693.
- Background: PubMed 9377769Shaked A. Use of T tube in liver transplantation. Liver Transpl Surg. 1997 Sep;3(5 Suppl 1):S22-3. No abstract 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.
Olivier SCATTON, PU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
Olivier SOUBRANE, PU-PH study director
Assistance Publique - Hôpitaux de Paris
Claire GOUMARD, MD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intraductal removable stent custom-made segment (2 cm) and stent extraction by ERCP in people with Transplantation, Liver, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 29 Oct 2021. 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 France. 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 was stopped early (reason given: Interruption of the study for safety reasons at the decision of the sponsor). Results are not available in the source record.
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?
Incidence of biliary strictures and biliary fistulae within six months post-transplantation. (time frame: 6 months). 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 NCT02356939, which also lists 30 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 29 Oct 2021.