Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-01-05 @ 6:31 PM
Study NCT ID:
NCT04144504
Status:
UNKNOWN
Last Update Posted:
2019-10-30
First Post:
2019-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plastic Stenting Versus Retrievable Metallic Stenting for Biliary Anastomotic Stricture After Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-29', 'studyFirstSubmitDate': '2019-10-09', 'studyFirstSubmitQcDate': '2019-10-29', 'lastUpdatePostDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of endoscopic sessions to achieve resolution of stricture', 'timeFrame': 'Two months', 'description': 'To compare the total number of treatments to successfully resolve the problem of biliary stricture in each arm'}, {'measure': 'Percentage of successful treatment', 'timeFrame': 'Two months', 'description': 'To compare the total rate of successful treatment in each arm'}, {'measure': 'Pain score after treatment', 'timeFrame': 'Two months', 'description': '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)'}, {'measure': "Patient's quality of life", 'timeFrame': 'Two months', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Complication rate', 'timeFrame': '2 months', 'description': 'To compare the rate of complications such as post-ERCP pancreatitis, bleeding and perforation between patients who have received plastic or metallic stents'}, {'measure': 'Hospital stay', 'timeFrame': 'Two months', 'description': 'To compare the duration of hospital stay between patients who have received plastic or metallic stents'}, {'measure': 'BAS recurrence', 'timeFrame': 'Two months', 'description': 'To compare the rate of BAS recurrence between patients who have received plastic or metallic stents'}, {'measure': 'Readmission rate', 'timeFrame': 'Two months', 'description': 'To compare the rate of readmission rate between patients who have received plastic or metallic stents'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Biliary Anastomotic Stenosis']}, 'referencesModule': {'references': [{'pmid': '21143651', 'type': 'BACKGROUND', 'citation': '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': '21445926', 'type': 'BACKGROUND', 'citation': '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': '17256781', 'type': 'BACKGROUND', 'citation': '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': '10827239', 'type': 'BACKGROUND', 'citation': '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': '11147942', 'type': 'BACKGROUND', 'citation': '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': '21074761', 'type': 'BACKGROUND', 'citation': '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': '20189508', 'type': 'BACKGROUND', 'citation': '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': '16482553', 'type': 'BACKGROUND', 'citation': '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': '17591473', 'type': 'BACKGROUND', 'citation': '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': '14528211', 'type': 'BACKGROUND', 'citation': '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': '24801350', 'type': 'BACKGROUND', 'citation': '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': '23657086', 'type': 'BACKGROUND', 'citation': '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': '20653071', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "Biliary anastomotic stricture (BAS) is one of the most common complications after liver transplantation (LT). It happens more often after living donor liver transplantation (LDLT) than deceased donor liver transplantation (DDLT). The reported incidence was 20% in LDLT and 12% in DDLT. Although BAS seldom affects graft survival, it is associated with significant morbidity and affects quality of life. Clinical manifestation of BAS can be highly variable, ranging from low-grade cholangitis with slightly deranged liver function to life-threatening septic shock to graft and multi-organ failure. Up to 30% of the cases of BAS require surgical intervention at some point. Revision hepaticojejunostomy - a major undertaking judging from the magnitude of the operation - is sometimes required as a remedial procedure. Most of the time BAS can be treated by endoscopic retrograde cholangiopancreatography (ERCP) 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. Since stricturoplasty features breaking up the fibrous ring at the anastomotic site and hence widening the calibre of the lumen, any new wound created by dilatation injury is susceptible to the formation of new scar. Therefore, some form of buttressing device is needed to keep the anastomotic site open. This underscores the importance of post-dilatation splintage. The most common and popular form of splintage is plastic stent insertion. Unfortunately, plastic biliary stents have a small calibre, with the largest size being Fr11.5 only. Even if multiple stents are inserted, 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. Frequent admissions for repeated dilatation and stent exchange (not to mention emergency admission for a cholangitic episode secondary to stent blockage) significantly disrupt the patient's normal daily activities and form a clinical and financial burden to the community. 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 condition. It has been reported that a series of 29 BAS patients 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 them had no stricture for at least 4 months after r-SEMS treatment and no complication was encountered. The median number of session for success was 2, which is significantly fewer than that in the ordinary approach (median session: 4).\n\nUp till this moment, there is no randomized controlled trial comparing the performance of r-SEMS with that of the conventional approach. In this study, the null hypothesis is that there is no difference in performance between r-SEMS and the conventional approach in endoscopic treatment of BAS."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who give informed consent\n\nExclusion Criteria:\n\n* Patients who refuse to give consent\n* Patients who have previously hepaticojejunostomy as biliary re-construction\n* Patients who have previous upper gastrointestinal surgery making endoscopic treatment not posssible'}, 'identificationModule': {'nctId': 'NCT04144504', 'acronym': 'LT', 'briefTitle': 'Plastic Stenting Versus Retrievable Metallic Stenting for Biliary Anastomotic Stricture After Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Prospective Randomized Controlled Trial on Balloon Dilatation and Plastic Stenting Versus Retrievable Metallic Stenting for Biliary Anastomotic Stricture After Liver Transplantation', 'orgStudyIdInfo': {'id': 'UW 19-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Plastic stenting', 'description': 'Patients with post-liver transplantation and suffer from biliary anastomotic stricture would be given balloon dilatation and plastic stenting for treatment.', 'interventionNames': ['Device: Plastic stenting']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Retrievable metallic stenting', 'description': 'Patients with post-liver transplantation and suffer from biliary anastomotic stricture would be given retrievable metallic stenting for treatment.', 'interventionNames': ['Device: Retrievable metallic stenting']}], 'interventions': [{'name': 'Retrievable metallic stenting', 'type': 'DEVICE', 'description': 'Use of retrievable metallic stents for the treatment of biliary anastomotic stricture after liver transplantation', 'armGroupLabels': ['Retrievable metallic stenting']}, {'name': 'Plastic stenting', 'type': 'DEVICE', 'description': 'Use of plastic stents', 'armGroupLabels': ['Plastic stenting']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Kenneth Chok', 'role': 'CONTACT', 'email': 'chok6275@hku.hk', 'phone': '08522553025'}], 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Kenneth Chok', 'role': 'CONTACT', 'email': 'chok6275@hku.hk', 'phone': '085222553025', 'phoneExt': '085222553025'}], 'overallOfficials': [{'name': 'Kenneth Chok', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Dr. Kenneth Siu-Ho Chok', 'investigatorAffiliation': 'The University of Hong Kong'}}}}