Study to Establish Whether the Use of T-Tube in Bile Duct Anastomosis in Liver Transplantation Decreases Morbidity
NCT ID: NCT01546064
Last Updated: 2012-03-07
Study Results
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Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2008-05-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bile duct anastomosis with T-tube
Choledocho-choledochostomy with T-tube
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.
Bile duct anastomosis without T-tube
Choledocho-choledochostomy without T-tube
The termino-terminal anastomosis between common bile duct of the graft and common bile duct of the recipient is performed without any T-tube.
Interventions
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Choledocho-choledochostomy with T-tube
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-tube
The termino-terminal anastomosis between common bile duct of the graft and common bile duct of the recipient is performed without any T-tube.
Eligibility Criteria
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Inclusion Criteria
* Aged \> 18 years
Exclusion Criteria
* Retransplantation
* Primary sclerosing cholangitis
* Fulminant hepatic failure
* Technical need for a hepaticojejunostomy
* Splitted graft
* 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
18 Years
67 Years
ALL
No
Sponsors
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Hospital Universitario La Fe
OTHER
Responsible Party
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Rafael Lopez Andujar
Head of Unit
Principal Investigators
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Rafael López-Andújar, Head of Unit
Role: PRINCIPAL_INVESTIGATOR
La Fe University and Politechnic Hospital
Locations
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La Fe University and Politechnic Hospital
Valencia, Valencia, Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Buczkowski AK, Schaeffer DF, Kim PT, Ho SG, Yoshida EM, Steinbrecher UP, Erb SR, Chung SW, Scudamore CH. Spatulated end-to-end bile duct reconstruction in orthotopic liver transplantation. Clin Transplant. 2007 Jan-Feb;21(1):7-12. doi: 10.1111/j.1399-0012.2006.00556.x.
Neuhaus 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.
Rabkin JM, Orloff SL, Reed MH, Wheeler LJ, Corless CL, Benner KG, Flora KD, Rosen HR, Olyaei AJ. Biliary tract complications of side-to-side without T tube versus end-to-end with or without T tube choledochocholedochostomy in liver transplant recipients. Transplantation. 1998 Jan 27;65(2):193-9. doi: 10.1097/00007890-199801270-00008.
Ben-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.
Randall HB, Wachs ME, Somberg KA, Lake JR, Emond JC, Ascher NL, Roberts JP. The use of the T tube after orthotopic liver transplantation. Transplantation. 1996 Jan 27;61(2):258-61. doi: 10.1097/00007890-199601270-00017.
Rossi G, Lucianetti A, Gridelli B, Colledan M, Caccamo L, Albani AP, Galmarini M, Fassati LR, Galmarini D. Biliary tract complications in 224 orthotopic liver transplantations. Transplant Proc. 1994 Dec;26(6):3626-8. No abstract available.
Sheng R, Sammon JK, Zajko AB, Campbell WL. Bile leak after hepatic transplantation: cholangiographic features, prevalence, and clinical outcome. Radiology. 1994 Aug;192(2):413-6. doi: 10.1148/radiology.192.2.8029406.
Grande L, Perez-Castilla A, Matus D, Rodriguez-Montalvo C, Rimola A, Navasa M, Garcia-Valdecasas JC, Visa J. Routine use of the T tube in the biliary reconstruction of liver transplantation: is it worthwhile? Transplant Proc. 1999 Sep;31(6):2396-7. doi: 10.1016/s0041-1345(99)00398-x. No abstract available.
Rolles 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.
Bacchella T, Figueira ER, Makdissi FF, Rocha-Santos V, Martino RB, Andraus W, Canedo LF, Machado MA, Machado MC. Biliary reconstruction without T-tube in liver transplantation. Transplant Proc. 2004 May;36(4):951-2. doi: 10.1016/j.transproceed.2004.03.103.
Kusano T, Randall HB, Roberts JP, Ascher NL. The use of stents for duct-to-duct anastomoses of biliary reconstruction in orthotopic liver transplantation. Hepatogastroenterology. 2005 May-Jun;52(63):695-9.
Weiss S, Schmidt SC, Ulrich F, Pascher A, Schumacher G, Stockmann M, Puhl G, Guckelberger O, Neumann UP, Pratschke J, Neuhaus P. Biliary reconstruction using a side-to-side choledochocholedochostomy with or without T-tube in deceased donor liver transplantation: a prospective randomized trial. Ann Surg. 2009 Nov;250(5):766-71. doi: 10.1097/SLA.0b013e3181bd920a.
Shuhart MC, Kowdley KV, McVicar JP, Rohrmann CA, McDonald MF, Wadland DW, Emerson SS, Carithers RL Jr, Kimmey MB. Predictors of bile leaks after T-tube removal in orthotopic liver transplant recipients. Liver Transpl Surg. 1998 Jan;4(1):62-70. doi: 10.1002/lt.500040109.
Koivusalo A, Eskelinen M, Wolff H, Talva M, Makisalo H. Development of T-tube tracts in piglets: effect of insertion method and material of T-tubes. Res Exp Med (Berl). 1997;197(1):53-61. doi: 10.1007/s004330050055.
Apalakis A. An experimental evaluation of the types of material used for bile duct drainage tubes. Br J Surg. 1976 Jun;63(6):440-5. doi: 10.1002/bjs.1800630608.
WINSTONE NE, GOLBY MG, LAWSON LJ, WINDSOR CW. BILIARY PERITONITIS: A HAZARD OF POLYVINYL CHLORIDE T-TUBES. Lancet. 1965 Apr 17;1(7390):843-4. doi: 10.1016/s0140-6736(65)91376-0. No abstract available.
Lopez-Andujar R, Oron EM, Carregnato AF, Suarez FV, Herraiz AM, Rodriguez FS, Carbo JJ, Ibars EP, Sos JE, Suarez AR, Castillo MP, Pallardo JM, De Juan Burgueno M. T-tube or no T-tube in cadaveric orthotopic liver transplantation: the eternal dilemma: results of a prospective and randomized clinical trial. Ann Surg. 2013 Jul;258(1):21-9. doi: 10.1097/SLA.0b013e318286e0a0.
Other Identifiers
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ESTUDIOKEHR
Identifier Type: -
Identifier Source: org_study_id
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