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

Evidence of Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01546064
• Other study ID #: ESTUDIOKEHR
• Status: Completed
• Phase: N/A
• First received: February 26, 2012
• Last updated: March 1, 2012
• Start date: May 2008
• Est. completion date: July 2011

Study information

• Verified date: March 2012
• Source: Hospital Universitario La Fe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 67 Years

Eligibility

Inclusion Criteria:

• Recipients of a deceased full-size liver graft

• Aged > 18 years

Exclusion Criteria:

• Age < 18 years

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Evidence of Liver Transplantation

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Spain	La Fe University and Politechnic Hospital	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Fe

Country where clinical trial is conducted

Spain, 

References & Publications (31)

Amador A, Charco R, Martí J, Navasa M, Rimola A, Calatayud D, Rodriguez-Laiz G, Ferrer J, Romero J, Ginesta C, Fondevila C, Fuster J, García-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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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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. Review. — View Citation

Grande L, Pérez-Castilla A, Matus D, Rodriguez-Montalvo C, Rimola A, Navasa M, García-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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

Nuño J, Vicente E, Turrión VS, Pereira F, Ardaiz J, Cuervas V, Bárcena R, García 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Riediger C, Müller MW, Michalski CW, Hüser 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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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. Review. — View Citation

* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The first year after liver transplantation procedure	Yes