Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-01-04 @ 12:00 AM
Study NCT ID:
NCT05556668
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2022-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Percutaneous Biodegradable Biliary Stents for the Treatment of Benign Biliary Strictures.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D041781', 'term': 'Jaundice, Obstructive'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007565', 'term': 'Jaundice'}, {'id': 'D006932', 'term': 'Hyperbilirubinemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-28', 'studyFirstSubmitDate': '2022-09-06', 'studyFirstSubmitQcDate': '2022-09-22', 'lastUpdatePostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stent Primary Patency', 'timeFrame': 'Time from stent implantation to new intervention due to restenosis or occlusion detected by clinical signs and symptoms and confirmed by blood-test disturbances and/or imaging tests), assessed up to 60 months', 'description': 'Time until new intervention due to re-stenosis or occlusion (detected by clinical signs and symptoms and confirmed by blood-test disturbances and/or imaging tests)'}, {'measure': 'Adverse Events', 'timeFrame': 'From stent implantation to completion of follow-up, up to 5 years', 'description': 'Major and minor complications. The Clavien-Dindo classification will be used for grading the severity of complications.'}], 'secondaryOutcomes': [{'measure': 'Technical Success', 'timeFrame': 'Immediate (during procedure)', 'description': 'To correctly deploy a biodegradable stent using a percutaneous approach covering the stricture with a residual stenosis of less than 30% of the lumen, and correct flow of contrast through it into the intestinal lumen'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'nights from admission to perform the stent implantation to discharge of the patient from the hospital, assessed up to 365 days', 'description': 'number of days that patients spend in hospital to have the stent inserted, including a 24-48h control cholangiogram'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Biliary Stricture', 'Biliary Tract Diseases', 'Bile Duct Stricture', 'Bile Duct Injury', 'Stents', 'Obstructive Jaundice']}, 'descriptionModule': {'briefSummary': 'To assess safety and effectiveness in the long term of percutaneous insertion of Biodegradable (BD) Biliary Stents for the treatment of benign biliary strictures, in a single center experience.', 'detailedDescription': "This is an observational study (retrospective analysis on a prospective database) of patients that have been implanted a biodegradable stent in the biliary tree to treat benign stenosis.\n\nFrom march 2011 until May 2020, a prospective collection of clinical data has been conducted in patients with symptomatic benign biliary strictures treated biodegradable polydioxanone stents. A strict follow-up protocol has been carried out according to standard practice (at 2, 4, 6 months and every 6 months up to 5 years). Once the follow-up is completed, the collected data will be analyzed, assessing the long term effectiveness and safety, but also other variables related to stent implantation and impact on patient's quality of life.\n\nA subgroup analysis of anastomotic biliary strictures will be performed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '50 patients with symptomatic benign biliary strictures from Parc Tauli University Hospital referral area and derived from other referring Hospitals treated in our center with a BBS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients over 18 years old attended in the interventional radiology department for the implantation of a biodegradable biliary stent (BBS: ELLA-CS, Hradec Kralove, Czech Republic), for each stenosis, by percutaneous technique.\n* Written informed consent given\n\nExclusion Criteria:\n\n* Patients under 18 years old\n* Patients with post-liver transplant biliary strictures\n* Patients for whom no post-intervention follow-up data are available\n* Patients in whom malignancy is demonstrated as a cause of the stricture after stent placement.'}, 'identificationModule': {'nctId': 'NCT05556668', 'briefTitle': 'Percutaneous Biodegradable Biliary Stents for the Treatment of Benign Biliary Strictures.', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'Role of Biodegradable Polydioxanone Biliary Stents for the Percutaneous Treatment of Benign Biliary Strictures.', 'orgStudyIdInfo': {'id': 'CSPT_ECP_2020_600'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Percutaneous placement of biodegradable biliary stents', 'type': 'DEVICE', 'description': 'Benign biliary strictures treated with polydioxanone (PPDX) stents (Ella-DV biliary stent, ELLACS, Hradec Králové, Czech Republic). The stents are implanted using a percutaneous transhepatic cholangiography. Before stent implantation, balloon bilioplasty is be performed.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08208', 'city': 'Sabadell', 'country': 'Spain', 'facility': 'Hospital Parc Tauli Sabadell', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}], 'overallOfficials': [{'name': 'Eva Criado-Paredes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corporació Universitaria Parc Tauli'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universitat Autonoma de Barcelona', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Eva Criado', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}