Evidence of Liver TransplantationNCT01546064

Study to Establish Whether the Use of T-Tube in Bile Duct Anastomosis in Liver Transplantation Decreases Morbidity

A study testing Choledocho-choledochostomy with T-tube and Choledocho-choledochostomy without T-tube in people with Evidence of Liver Transplantation, run by Hospital Universitario La Fe at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 67 years
Conditions the study is for: Evidence of Liver Transplantation
What is being tested?: Choledocho-choledochostomy with T-tube and Choledocho-choledochostomy without T-tube
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteSpain
Study dates: May 2008to Jul 2011
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 67 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Recipients of a deceased full-size liver graft
Aged > 18 years

Who cannot join

Age < 18 years
Retransplantation
Primary sclerosing cholangitis
Fulminant hepatic failure
Technical need for a hepaticojejunostomy
Splitted graft

Show all 10Show fewer

Reduced-size graft
More than one organ transplantation
Living donation
Finding of a large difference (twice the size) in common bile duct diameters between the graft and the recipient

Trial locations and contacts

1 site in 1 country.

Spain1 site

La Fe University and Politechnic Hospital
Valencia, Valencia, 46026

Other trials in Spain

About this study

Official title: Prospective and Randomized Trial on the Usefulness of T-Tube in the Bile Duct Anastomosis in Liver Transplantation Procedure.

The purpose of this study was to compare the incidence and severity of biliary complications due to liver transplantation after choledochocholedochostomy with or without a T-tube. A per-protocol analysis was designed for recipients of orthotopic liver transplantation in a single center, who were randomly assigned to choledochocholedochostomy with or without a T-tube. It is a prospective and randomized study.

Conditions: Evidence of Liver Transplantation
Being tested: Choledocho-choledochostomy with T-tube, Choledocho-choledochostomy without T-tube
Keywords: Bile duct anastomosis, Biliary complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Choledocho-choledochostomy with T-tubeDevice
In the anastomosis between the common bile duct of the graft and the common bile duct of the recipient, a tutorial T-tube is inserted in the bile duct lumen and will be removed from the patient on third month postoperatively.
Choledocho-choledochostomy without T-tubeDevice
The termino-terminal anastomosis between common bile duct of the graft and common bile duct of the recipient is performed without any T-tube.

Study groups in NCT01546064
Study group	Role	What they receive
Bile duct anastomosis with T-tube	Active comparator	Not described Receives: Device: Choledocho-choledochostomy with T-tube
Bile duct anastomosis without T-tube	Active comparator	Not described Receives: Device: Choledocho-choledochostomy without T-tube

What is being measured

The primary outcome is the main question the study is designed to answer.

all morbidity related to bile duct
All the complications related to bile duct that appear after transplantation will be recorded in both groups. All patients will be followed up for the first 12 months after transplantation.
Measured: The first year after liver transplantation procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2008Jul 2011

First posted7 Mar 2012 (estimated)
Study startMay 2008
Primary completionJul 2010
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (32)Papers the sponsor has linked to this study.
Other trials for Evidence of Liver TransplantationStudies 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: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01546064
Sponsor's protocol ID: ESTUDIOKEHR
Status last verified: Mar 2012
First submitted: 26 Feb 2012
Last updated: 7 Mar 2012
Results posted: No
Data monitoring committee: No

Publications

Duailibi 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 20304182
Wojcicki M, Milkiewicz P, Silva M. Biliary tract complications after liver transplantation: a review. Dig Surg. 2008;25(4):245-57. doi: 10.1159/000144653. Epub 2008 Jul 15.
PubMed 18628624
Ayoub WS, Esquivel CO, Martin P. Biliary complications following liver transplantation. Dig Dis Sci. 2010 Jun;55(6):1540-6. doi: 10.1007/s10620-010-1217-2. Epub 2010 Apr 22.
PubMed 20411422
Kizilisik TA, al-Sebayel M, Hammad A, al-Traif I, Ramirez CG. Biliary complications after T-tube placement in liver transplant patients. Transplant Proc. 1997 Nov;29(7):2849-50. doi: 10.1016/s0041-1345(97)00704-5. No abstract available.
PubMed 9365588
Rouch DA, Emond JC, Thistlethwaite JR Jr, Mayes JT, Broelsch CE. Choledochocholedochostomy without a T tube or internal stent in transplantation of the liver. Surg Gynecol Obstet. 1990 Mar;170(3):239-44.
PubMed 2406979
Amador A, Charco R, Marti J, Navasa M, Rimola A, Calatayud D, Rodriguez-Laiz G, Ferrer J, Romero J, Ginesta C, Fondevila C, Fuster J, Garcia-Valdecasas JC. Clinical trial on the cost-effectiveness of T-tube use in an established deceased donor liver transplantation program. Clin Transplant. 2007 Jul-Aug;21(4):548-53. doi: 10.1111/j.1399-0012.2007.00688.x.
PubMed 17645718
Scatton O, Meunier B, Cherqui D, Boillot O, Sauvanet A, Boudjema K, Launois B, Fagniez PL, Belghiti J, Wolff P, Houssin D, Soubrane O. Randomized trial of choledochocholedochostomy with or without a T tube in orthotopic liver transplantation. Ann Surg. 2001 Mar;233(3):432-7. doi: 10.1097/00000658-200103000-00019.
PubMed 11224633
Nuno J, Vicente E, Turrion VS, Pereira F, Ardaiz J, Cuervas V, Barcena R, Garcia M, San Roman AL, Candela A, Honrubia A, Moreno A. Biliary tract reconstruction after liver transplantation: with or without T-tube? Transplant Proc. 1997 Feb-Mar;29(1-2):564-5. doi: 10.1016/s0041-1345(96)00268-0. No abstract available.
PubMed 9123131
Vougas 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
Sotiropoulos GC, Sgourakis G, Radtke A, Molmenti EP, Goumas K, Mylona S, Fouzas I, Karaliotas C, Lang H. Orthotopic liver transplantation: T-tube or not T-tube? Systematic review and meta-analysis of results. Transplantation. 2009 Jun 15;87(11):1672-80. doi: 10.1097/TP.0b013e3181a5cf3f.
PubMed 19502959
Riediger C, Muller MW, Michalski CW, Huser N, Schuster T, Kleeff J, Friess H. T-Tube or no T-tube in the reconstruction of the biliary tract during orthotopic liver transplantation: systematic review and meta-analysis. Liver Transpl. 2010 Jun;16(6):705-17. doi: 10.1002/lt.22070.
PubMed 20517904
Paes-Barbosa FC, Massarollo PC, Bernardo WM, Ferreira FG, Barbosa FK, Raslan M, Szutan LA. Systematic review and meta-analysis of biliary reconstruction techniques in orthotopic deceased donor liver transplantation. J Hepatobiliary Pancreat Sci. 2011 Jul;18(4):525-36. doi: 10.1007/s00534-010-0346-5.
PubMed 21127915
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542
Starzl TE, Putnam CW, Hansbrough JF, Porter KA, Reid HA. Biliary complications after liver transplantation: with special reference to the biliary cast syndrome and techniques of secondary duct repair. Surgery. 1977 Feb;81(2):212-21.
PubMed 319551
Calne RY, McMaster P, Portmann B, Wall WJ, Williams R. Observations on preservation, bile drainage and rejection in 64 human orthotopic liver allografts. Ann Surg. 1977 Sep;186(3):282-90. doi: 10.1097/00000658-197709000-00006.
PubMed 329780

Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective and Randomized Trial on the Usefulness of T-Tube in the Bile Duct Anastomosis in Liver Transplantation Procedure.
ClinicalTrials.gov ID: NCT01546064
Acronym / sponsor ID: ESTUDIOKEHR
Conditions: Evidence of Liver Transplantation
Keywords: Bile duct anastomosis, Biliary complications
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Hospital Universitario La FeUniversity, hospital or other
Study start: May 2008
Primary completion: Jul 2010 (actual)
Study completion: Jul 2011 (actual)
First posted: 7 Mar 2012 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Bile duct anastomosis with T-tube	Active comparator	Device: Choledocho-choledochostomy with T-tube
Bile duct anastomosis without T-tube	Active comparator	Device: Choledocho-choledochostomy without T-tube

Who may qualify

Ages: 18 to 67 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Recipients of a deceased full-size liver graft
Aged > 18 years

Key exclusion criteria (10 listed)

Age < 18 years
Retransplantation
Primary sclerosing cholangitis
Fulminant hepatic failure
Technical need for a hepaticojejunostomy

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
Choledocho-choledochostomy with T-tubeIn the anastomosis between the common bile duct of the graft and the common bile duct of the recipient, a tutorial T-tube is inserted in the bile duct lumen and will be removed from the patient on third month postoperatively.	Device	Bile duct anastomosis with T-tube
Choledocho-choledochostomy without T-tubeThe termino-terminal anastomosis between common bile duct of the graft and common bile duct of the recipient is performed without any T-tube.	Device	Bile duct anastomosis without T-tube

Primary outcome

all morbidity related to bile duct
Time frame: The first year after liver transplantation procedure
All the complications related to bile duct that appear after transplantation will be recorded in both groups. All patients will be followed up for the first 12 months after transplantation.

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 7 Mar 2012.
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 18628624Wojcicki M, Milkiewicz P, Silva M. Biliary tract complications after liver transplantation: a review. Dig Surg. 2008;25(4):245-57. doi: 10.1159/000144653. Epub 2008 Jul 15.
Background: PubMed 20411422Ayoub WS, Esquivel CO, Martin P. Biliary complications following liver transplantation. Dig Dis Sci. 2010 Jun;55(6):1540-6. doi: 10.1007/s10620-010-1217-2. Epub 2010 Apr 22.
Background: PubMed 9365588Kizilisik TA, al-Sebayel M, Hammad A, al-Traif I, Ramirez CG. Biliary complications after T-tube placement in liver transplant patients. Transplant Proc. 1997 Nov;29(7):2849-50. doi: 10.1016/s0041-1345(97)00704-5. No abstract available.
Background: PubMed 2406979Rouch DA, Emond JC, Thistlethwaite JR Jr, Mayes JT, Broelsch CE. Choledochocholedochostomy without a T tube or internal stent in transplantation of the liver. Surg Gynecol Obstet. 1990 Mar;170(3):239-44.
Background: PubMed 17645718Amador A, Charco R, Marti J, Navasa M, Rimola A, Calatayud D, Rodriguez-Laiz G, Ferrer J, Romero J, Ginesta C, Fondevila C, Fuster J, Garcia-Valdecasas JC. Clinical trial on the cost-effectiveness of T-tube use in an established deceased donor liver transplantation program. Clin Transplant. 2007 Jul-Aug;21(4):548-53. doi: 10.1111/j.1399-0012.2007.00688.x.
Background: PubMed 11224633Scatton O, Meunier B, Cherqui D, Boillot O, Sauvanet A, Boudjema K, Launois B, Fagniez PL, Belghiti J, Wolff P, Houssin D, Soubrane O. Randomized trial of choledochocholedochostomy with or without a T tube in orthotopic liver transplantation. Ann Surg. 2001 Mar;233(3):432-7. doi: 10.1097/00000658-200103000-00019.
Background: PubMed 9123131Nuno J, Vicente E, Turrion VS, Pereira F, Ardaiz J, Cuervas V, Barcena R, Garcia M, San Roman AL, Candela A, Honrubia A, Moreno A. Biliary tract reconstruction after liver transplantation: with or without T-tube? Transplant Proc. 1997 Feb-Mar;29(1-2):564-5. doi: 10.1016/s0041-1345(96)00268-0. No abstract available.
Background: PubMed 8819276Vougas 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.
Background: PubMed 19502959Sotiropoulos GC, Sgourakis G, Radtke A, Molmenti EP, Goumas K, Mylona S, Fouzas I, Karaliotas C, Lang H. Orthotopic liver transplantation: T-tube or not T-tube? Systematic review and meta-analysis of results. Transplantation. 2009 Jun 15;87(11):1672-80. doi: 10.1097/TP.0b013e3181a5cf3f.
Background: PubMed 20517904Riediger C, Muller MW, Michalski CW, Huser N, Schuster T, Kleeff J, Friess H. T-Tube or no T-tube in the reconstruction of the biliary tract during orthotopic liver transplantation: systematic review and meta-analysis. Liver Transpl. 2010 Jun;16(6):705-17. doi: 10.1002/lt.22070.
Background: PubMed 21127915Paes-Barbosa FC, Massarollo PC, Bernardo WM, Ferreira FG, Barbosa FK, Raslan M, Szutan LA. Systematic review and meta-analysis of biliary reconstruction techniques in orthotopic deceased donor liver transplantation. J Hepatobiliary Pancreat Sci. 2011 Jul;18(4):525-36. doi: 10.1007/s00534-010-0346-5.

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.

Rafael López-Andújar, Head of Unit principal investigator

La Fe University and Politechnic Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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: finished, as of the sponsor's last update on 7 Mar 2012. 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 Spain. 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?

all morbidity related to bile duct (time frame: The first year after liver transplantation procedure). 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 NCT01546064, which also lists 32 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 7 Mar 2012.