Plastic Stenting Versus Retrievable Metallic Stenting for Biliary Anastomotic Stricture After Liver Transplantation

NCT04144504 | Unknown DMC

• 1 other identifier: UW 19-006
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Liver transplantation is the best treatment option for patients with end-stage liver disease and early unresectable hepatocellular carcinoma. Unfortunately, biliary complication after liver transplantation is still the Achilles' heel, especially in living donor liver transplantation. Early treatment with endoscopy can achieve satisfactory outcomes. Most of the time, biliary anastomotic stricture can be treated by endoscopic retrograde cholangiopancreatography with balloon dilatation with or without plastic stent insertion. Although endoscopic treatment has been reported to have a successful rate of over 70%, multiple sessions of endoscopic treatment, typically 4 to 5 sessions, are frequently required before adequate stricture dilatation is achieved. This is likely secondary to suboptimal post-dilatation splintage. The most common and popular form of splintage is plastic stent insertion. Unfortunately, plastic biliary stent has a small calibre, and therefore even with multiple stents the configuration of buttressing would not provide a circumferential, evenly distributed buttressing effect at the dilated stricture site. Moreover, given the small calibre of the plastic stent, there is higher resistance on the inner surface of the stent, leading to a higher chance of stent blockage. Many studies have suggested that self-expandable metallic stent (SEMS) is superior to plastic stent in terms of patency rate. However, SEMS is generally reserved for malignant stricture due to its permanent nature, as the traditional SEMS is not removable. Recently, retrievable SEMS (r-SEMS) has been developed, and its indications have been extended to include benign disease conditions. It has been reported that a series of 29 patients with biliary anastomotic stricture treated by r-SEMS, and they concluded that r-SEMS was safe and efficacious. Results of the preliminary study on 5 patients at our centre were favourable; all of the patients had no stricture after retrievable metallic stenting for at least 3 months and no complication was encountered.

Conditions

Biliary Anastomotic Stenosis

Outcome Measures

Primary Outcomes (4)

• Number of endoscopic sessions to achieve resolution of stricture

  To compare the total number of treatments to successfully resolve the problem of biliary stricture in each arm

  Two months

• Percentage of successful treatment

  To compare the total rate of successful treatment in each arm

  Two months

• Pain score after treatment

  To compare the differential pain score experienced by patients in each arm as rated by facial pain score scale (Ranging from 0-10) Maximum pain score = 10; No pain = 0)

  Two months

• Patient's quality of life

  To compare the quality of life as experienced by patients who have undergone stenting treatment(s) in each arm using SF36 questionnaire with maximum score=100 as the best outcome and minimum score=0 as the worst

  Two months

Secondary Outcomes (4)

• Complication rate

  2 months

• Hospital stay

  Two months

• BAS recurrence

  Two months

• Readmission rate

  Two months

Study Arms (2)

Plastic stenting

ACTIVE COMPARATOR

Patients with post-liver transplantation and suffer from biliary anastomotic stricture would be given balloon dilatation and plastic stenting for treatment.

Device: Plastic stenting

Retrievable metallic stenting

ACTIVE COMPARATOR

Patients with post-liver transplantation and suffer from biliary anastomotic stricture would be given retrievable metallic stenting for treatment.

Device: Retrievable metallic stenting

Interventions

Retrievable metallic stenting DEVICE

Use of retrievable metallic stents for the treatment of biliary anastomotic stricture after liver transplantation

Retrievable metallic stenting

Plastic stenting DEVICE

Use of plastic stents

Plastic stenting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who give informed consent

You may not qualify if:

• Patients who refuse to give consent
• Patients who have previously hepaticojejunostomy as biliary re-construction
• Patients who have previous upper gastrointestinal surgery making endoscopic treatment not posssible

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (13)

• Akamatsu 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.

  PMID: 21143651 BACKGROUND

• Sundaram V, Jones DT, Shah NH, de Vera ME, Fontes P, Marsh JW, Humar A, Ahmad J. Posttransplant biliary complications in the pre- and post-model for end-stage liver disease era. Liver Transpl. 2011 Apr;17(4):428-35. doi: 10.1002/lt.22251.

  PMID: 21445926 BACKGROUND

• Castaldo ET, Pinson CW, Feurer ID, Wright JK, Gorden DL, Kelly BS, Chari RS. Continuous versus interrupted suture for end-to-end biliary anastomosis during liver transplantation gives equal results. Liver Transpl. 2007 Feb;13(2):234-8. doi: 10.1002/lt.20986.

  PMID: 17256781 BACKGROUND

• Johnson MW, Thompson P, Meehan A, Odell P, Salm MJ, Gerber DA, Zacks SL, Fried MW, Shrestha R, Fair JH. Internal biliary stenting in orthotopic liver transplantation. Liver Transpl. 2000 May;6(3):356-61. doi: 10.1053/lv.2000.5303.

  PMID: 10827239 BACKGROUND

• Mahajani RV, Cotler SJ, Uzer MF. Efficacy of endoscopic management of anastomotic biliary strictures after hepatic transplantation. Endoscopy. 2000 Dec;32(12):943-9. doi: 10.1055/s-2000-9619.

  PMID: 11147942 BACKGROUND

• Buxbaum JL, Biggins SW, Bagatelos KC, Ostroff JW. Predictors of endoscopic treatment outcomes in the management of biliary problems after liver transplantation at a high-volume academic center. Gastrointest Endosc. 2011 Jan;73(1):37-44. doi: 10.1016/j.gie.2010.09.007. Epub 2010 Nov 12.

  PMID: 21074761 BACKGROUND

• Tabibian JH, Asham EH, Han S, Saab S, Tong MJ, Goldstein L, Busuttil RW, Durazo FA. Endoscopic treatment of postorthotopic liver transplantation anastomotic biliary strictures with maximal stent therapy (with video). Gastrointest Endosc. 2010 Mar;71(3):505-12. doi: 10.1016/j.gie.2009.10.023.

  PMID: 20189508 BACKGROUND

• Graziadei IW, Schwaighofer H, Koch R, Nachbaur K, Koenigsrainer A, Margreiter R, Vogel W. Long-term outcome of endoscopic treatment of biliary strictures after liver transplantation. Liver Transpl. 2006 May;12(5):718-25. doi: 10.1002/lt.20644.

  PMID: 16482553 BACKGROUND

• Pasha SF, Harrison ME, Das A, Nguyen CC, Vargas HE, Balan V, Byrne TJ, Douglas DD, Mulligan DC. Endoscopic treatment of anastomotic biliary strictures after deceased donor liver transplantation: outcomes after maximal stent therapy. Gastrointest Endosc. 2007 Jul;66(1):44-51. doi: 10.1016/j.gie.2007.02.017.

  PMID: 17591473 BACKGROUND

• Morelli J, Mulcahy HE, Willner IR, Cunningham JT, Draganov P. Long-term outcomes for patients with post-liver transplant anastomotic biliary strictures treated by endoscopic stent placement. Gastrointest Endosc. 2003 Sep;58(3):374-9. doi: 10.1067/s0016-5107(03)00011-7.

  PMID: 14528211 BACKGROUND

• Deviere J, Nageshwar Reddy D, Puspok A, Ponchon T, Bruno MJ, Bourke MJ, Neuhaus H, Roy A, Gonzalez-Huix Llado F, Barkun AN, Kortan PP, Navarrete C, Peetermans J, Blero D, Lakhtakia S, Dolak W, Lepilliez V, Poley JW, Tringali A, Costamagna G; Benign Biliary Stenoses Working Group. Successful management of benign biliary strictures with fully covered self-expanding metal stents. Gastroenterology. 2014 Aug;147(2):385-95; quiz e15. doi: 10.1053/j.gastro.2014.04.043. Epub 2014 May 4.

  PMID: 24801350 BACKGROUND

• Chok KS, Chan SC, Cheung TT, Sharr WW, Chan AC, Fan ST, Lo CM. A retrospective study on risk factors associated with failed endoscopic treatment of biliary anastomotic stricture after right-lobe living donor liver transplantation with duct-to-duct anastomosis. Ann Surg. 2014 Apr;259(4):767-72. doi: 10.1097/SLA.0b013e318294d0ce.

  PMID: 23657086 BACKGROUND

• Tee HP, James MW, Kaffes AJ. Placement of removable metal biliary stent in post-orthotopic liver transplantation anastomotic stricture. World J Gastroenterol. 2010 Jul 28;16(28):3597-600. doi: 10.3748/wjg.v16.i28.3597.

  PMID: 20653071 BACKGROUND

Study Officials

• Kenneth Chok

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth Chok

CONTACT

085222553025; chok6275@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 30, 2019
• Study Start: April 12, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 30, 2019

Record last verified: 2019-10

Locations

HK (1)