Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-04 @ 4:05 PM
Study NCT ID:
NCT04805450
Status:
UNKNOWN
Last Update Posted:
2023-03-21
First Post:
2015-08-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sems Placement With and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1075}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-20', 'studyFirstSubmitDate': '2015-08-18', 'studyFirstSubmitQcDate': '2021-03-17', 'lastUpdatePostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the need for ES before SEMS placement in patients with malignant bile duct obstruction.', 'timeFrame': 'During procedure'}], 'secondaryOutcomes': [{'measure': 'To evaluate immediate and delayed post ERCP complications including pancreatitis, SEMS migration, bleeding and perforation.', 'timeFrame': 'periprocedural and 30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Malignant Bile Duct Obstruction']}, 'referencesModule': {'references': [{'pmid': '22297801', 'type': 'BACKGROUND', 'citation': 'Dumonceau JM, Tringali A, Blero D, Deviere J, Laugiers R, Heresbach D, Costamagna G; European Society of Gastrointestinal Endoscopy. Biliary stenting: indications, choice of stents and results: European Society of Gastrointestinal Endoscopy (ESGE) clinical guideline. Endoscopy. 2012 Mar;44(3):277-98. doi: 10.1055/s-0031-1291633. Epub 2012 Feb 1.'}, {'pmid': '18027045', 'type': 'BACKGROUND', 'citation': 'Simmons DT, Petersen BT, Gostout CJ, Levy MJ, Topazian MD, Baron TH. Risk of pancreatitis following endoscopically placed large-bore plastic biliary stents with and without biliary sphincterotomy for management of postoperative bile leaks. Surg Endosc. 2008 Jun;22(6):1459-63. doi: 10.1007/s00464-007-9643-8. Epub 2007 Nov 20.'}, {'pmid': '18285718', 'type': 'BACKGROUND', 'citation': 'Artifon EL, Sakai P, Ishioka S, Marques SB, Lino AS, Cunha JE, Jukemura J, Cecconello I, Carrilho FJ, Opitz E, Kumar A. Endoscopic sphincterotomy before deployment of covered metal stent is associated with greater complication rate: a prospective randomized control trial. J Clin Gastroenterol. 2008 Aug;42(7):815-9. doi: 10.1097/MCG.0b013e31803dcd8a.'}, {'pmid': '15069728', 'type': 'BACKGROUND', 'citation': 'Giorgio PD, Luca LD. Comparison of treatment outcomes between biliary plastic stent placements with and without endoscopic sphincterotomy for inoperable malignant common bile duct obstruction. World J Gastroenterol. 2004 Apr 15;10(8):1212-4. doi: 10.3748/wjg.v10.i8.1212.'}, {'pmid': '25320543', 'type': 'BACKGROUND', 'citation': 'Cui PJ, Yao J, Zhao YJ, Han HZ, Yang J. Biliary stenting with or without sphincterotomy for malignant biliary obstruction: a meta-analysis. World J Gastroenterol. 2014 Oct 14;20(38):14033-9. doi: 10.3748/wjg.v20.i38.14033.'}]}, 'descriptionModule': {'briefSummary': 'Placement of biliary self expanding metal stent (SEMS) is indicated when malignant common bile duct obstruction is encountered \\[1\\]. Currently, there is still controversy regarding the use of endoscopic sphincterotomy (EST) before the placement of biliary stents \\[2-5\\].\n\nThe aim of this prospective randomized, multicenter study is to investigate the role of EST before fully covered SEMS placement in patients with neoplastic biliary obstruction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Inclusion criteria\n\n * Patients referred for endoscopic retrograde cholangiopancreatography\n * Malignant bile duct obstruction\n * Signed written informed consent\n * Age \\> 18\n* Exclusion criteria\n\n * Inability to provide inform consent\n * Pregnancy or lactation\n * Suspected perforation of the GI tract\n * Anatomical alterations due to previous surgery (Billroth surgery)\n * Coagulation alterations'}, 'identificationModule': {'nctId': 'NCT04805450', 'acronym': 'SEMS', 'briefTitle': 'Sems Placement With and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Clinico Humanitas'}, 'officialTitle': 'A Prospective, Randomized, Multicenter Study Comparing Sems Placement With and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction', 'orgStudyIdInfo': {'id': 'ES vs noES-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ES before SEMS placement', 'description': 'ERCP with ES before biliary fully covered SEMS placement.', 'interventionNames': ['Procedure: ES before fully covered SEMS placement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'no ES before SEMS placement', 'description': 'ERCP without ES before biliary fully covered SEMS placement.', 'interventionNames': ['Procedure: no ES before fully covered SEMS placement']}], 'interventions': [{'name': 'ES before fully covered SEMS placement', 'type': 'PROCEDURE', 'armGroupLabels': ['ES before SEMS placement']}, {'name': 'no ES before fully covered SEMS placement', 'type': 'PROCEDURE', 'armGroupLabels': ['no ES before SEMS placement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano', 'state': 'Milano', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}], 'centralContacts': [{'name': 'Andrea Anderloni, MD, PhD', 'role': 'CONTACT', 'email': 'andrea.anderloni@humanitas.it', 'phone': '00390282247308'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Clinico Humanitas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Michele Tedeschi', 'investigatorAffiliation': 'Istituto Clinico Humanitas'}}}}