Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-30 @ 5:47 AM
Study NCT ID:
NCT03463668
Status:
RECRUITING
Last Update Posted:
2018-03-13
First Post:
2018-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy of Duodenal Prostheses Not Covered Over 6 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C535720', 'term': 'Familial duodenal atresia'}, {'id': 'D011707', 'term': 'Pyloric Stenosis'}], 'ancestors': [{'id': 'D017219', 'term': 'Gastric Outlet Obstruction'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-12', 'studyFirstSubmitDate': '2018-03-05', 'studyFirstSubmitQcDate': '2018-03-12', 'lastUpdatePostDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dysphagia assessment', 'timeFrame': '7 years', 'description': 'GOOSS = Gastric Outlet Obstruction Scoring System'}], 'secondaryOutcomes': [{'measure': 'Rate of complications', 'timeFrame': '7 years', 'description': 'Rate of complications'}, {'measure': 'postoperative survival', 'timeFrame': '7 years', 'description': 'defined as the time between the date of duodenal prosthesis insertion and the date of death or the latest news'}, {'measure': 'Permeability duration of the duodenal stent', 'timeFrame': '7 years', 'description': "defined as the time between the date of the laying of the duodenal stent and date of patient's death or RED or surgery (exceptional case) or latest news"}, {'measure': 'Rate of duodenal endoscopic resection at 1 and 3 months postoperatively', 'timeFrame': 'at 1 and 3 months postoperatively', 'description': 'Rate of duodenal endoscopic resection at 1 and 3 months postoperatively'}, {'measure': 'Rate of biliary endoscopic resection at 1 and 3 months postoperatively', 'timeFrame': 'at 1 and 3 months postoperatively', 'description': 'Rate of biliary endoscopic resection at 1 and 3 months postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['duodenal stenosis', 'pyloric stenosis', 'digestive neoplasias', 'non-digestive neoplasias', 'duodenal prosthesis'], 'conditions': ['Digestive or Non-digestive Neoplasia Leading to Symptomatic Duodenal Stenosis']}, 'referencesModule': {'references': [{'pmid': '15015607', 'type': 'BACKGROUND', 'citation': 'Fiori E, Lamazza A, Volpino P, Burza A, Paparelli C, Cavallaro G, Schillaci A, Cangemi V. Palliative management of malignant antro-pyloric strictures. Gastroenterostomy vs. endoscopic stenting. A randomized prospective trial. Anticancer Res. 2004 Jan-Feb;24(1):269-71.'}, {'pmid': '15457364', 'type': 'BACKGROUND', 'citation': 'Johnsson E, Thune A, Liedman B. Palliation of malignant gastroduodenal obstruction with open surgical bypass or endoscopic stenting: clinical outcome and health economic evaluation. World J Surg. 2004 Aug;28(8):812-7. doi: 10.1007/s00268-004-7329-0. Epub 2004 Aug 3.'}, {'pmid': '17474082', 'type': 'BACKGROUND', 'citation': 'Jeurnink SM, Steyerberg EW, Hof Gv, van Eijck CH, Kuipers EJ, Siersema PD. Gastrojejunostomy versus stent placement in patients with malignant gastric outlet obstruction: a comparison in 95 patients. J Surg Oncol. 2007 Oct 1;96(5):389-96. doi: 10.1002/jso.20828.'}, {'type': 'BACKGROUND', 'citation': 'ASGE guidelines enteral stents'}]}, 'descriptionModule': {'briefSummary': 'To assess the efficacy of duodenal prostheses for duodenal stenosis established for endoscopic pyloric or duodenal stenosis on dysphagia', 'detailedDescription': 'Duodenal prostheses have become, since the 2000s, the first-line treatment of unresectable duodenal tumoral stenosis. The technical success is greater than 90%, however the endoscopic revisions that are duodenal or biliary are frequent. The IPC as a center of interventional endoscopy is very often in charge of these stenoses. We wanted to evaluate the efficiency and the duration of this effectiveness in current situation. Is there still room for gastrojejunal gastrojejunal surgery or for the development of endoscopic gastrojejunal anastomoses?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any symptomatic duodenal stenosis with symptomatic duodenal duodenal prosthesis between 2010 and 2017.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any symptomatic duodenal stenosis with symptomatic duodenal duodenal prosthesis between 2010 and 2017.\n\nExclusion Criteria:\n\n* Benign stenosis or covered metallic duodenal prosthesis (usually indicated for benign disease)'}, 'identificationModule': {'nctId': 'NCT03463668', 'acronym': 'DYSPHAGIE', 'briefTitle': 'Evaluation of the Efficacy of Duodenal Prostheses Not Covered Over 6 Years', 'organization': {'class': 'OTHER', 'fullName': 'Institut Paoli-Calmettes'}, 'officialTitle': 'Evaluation of the Efficacy of Duodenal Prostheses Not Covered Over 6 Years', 'orgStudyIdInfo': {'id': 'DYSPHAGIE-IPC 2017-036'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'symptomatic non-covered duodenal prosthesis', 'description': 'Any symptomatic duodenal stenosis with symptomatic duodenal duodenal prosthesis between 2010 and 2017.', 'interventionNames': ['Device: uncovered metal duodenal prosthesis']}], 'interventions': [{'name': 'uncovered metal duodenal prosthesis', 'type': 'DEVICE', 'description': 'Implantation of an uncovered metal duodenal prosthesis for symptomatic tumor stenosis', 'armGroupLabels': ['symptomatic non-covered duodenal prosthesis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13009', 'city': 'Marseille', 'state': 'Bouches Du Rhone', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dominique GENRE, MD', 'role': 'CONTACT', 'email': 'drci.up@ipc.unicancer.fr', 'phone': '33 4 91 22 37 78'}], 'facility': 'Institut Paoli Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'Fabrice CAILLOL', 'role': 'CONTACT', 'email': 'CAILLOLF@ipc.unicancer.fr', 'phone': '0491223531'}, {'name': 'Jean-Philippe RATONE', 'role': 'CONTACT', 'email': 'RATONEJ@ipc.unicancer.fr', 'phone': '0491227727'}], 'overallOfficials': [{'name': 'Fabrice CAILLOL', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Paoli-Calmettes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Paoli-Calmettes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}