Ignite Creation Date:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-29 @ 4:47 PM
Study NCT ID:
NCT05632900
Status:
COMPLETED
Last Update Posted:
2023-02-24
First Post:
2022-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COMPARISON OF OUTCOMES OF BI-FLANGED METAL STENT ALONE VERSUS BI-FLANGED METAL STENT WITH CO-AXIAL PLASTIC STENT FOR DRAINAGE OF WALLED-OFF PANCREATIC NECROSIS - A PROSPECTIVE RANDOMISED CONTROLLED STUDY.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-22', 'studyFirstSubmitDate': '2022-11-21', 'studyFirstSubmitQcDate': '2022-11-21', 'lastUpdatePostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse evens rates associated with both the groups ( stent clogging and stent migration, bleeding).', 'timeFrame': '4 weeks', 'description': 'To monitor the adverse events like bleeding, stent clogging and stent migration.'}], 'secondaryOutcomes': [{'measure': 're-intervention rates', 'timeFrame': '4 weeks', 'description': 'Number of sessions of Direct Endoscopic necrosectomy and De clogging of stent'}, {'measure': 'Technical success rate', 'timeFrame': '4 weeks', 'description': 'Deployment of Stent'}, {'measure': 'Clinical success rate', 'timeFrame': '4 weeks', 'description': 'Resolution of symptoms Resolution of size of walled of necrosis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ENDOSCOPIC ULTRASONOGRAPHY']}, 'descriptionModule': {'briefSummary': 'Endoscopic ultrasound guided drainage of WON with metal stent is the mainstay of WON management.\n\nBut there are few complications related to BFMS , like bleeding due to vessel erosion, stent clogging , stent migration .\n\nThis study is to assess, whether placing an anchoring DPS through the BFMS will decrease adverse events or not.\n\nThere are only 2 retrospective studies till date ,comparing LAMS with coaxial stent vs LAMS alone.\n\none study showed no significant decrease in adverse events , one study showed decrease in adverse events when DPS with LAMS .\n\nBut there has been no prospective RCT to assess the utility of DPS to date', 'detailedDescription': 'Inclusion Criteria: -\n\n1. Symptomatic Walled-off pancreatic necrosis (WON)\n2. Eligible for EUS guided BFMS placement\n3. Signed informed consent .\n4. Age \\>18 Years\n\nExclusion Criteria: -\n\n1. Types of pancreatic collections other than WON .\n2. Drainage with stents other than BFMS\n3. Previous attempts at drainage of WON\n4. Coagulopathy (INR\\>1.5) or thrombocytopenia(plc \\<50000/cmm)- not correctable.\n5. Pregnancy\n6. Not willing to give informed consent'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Symptomatic Walled-off pancreatic necrosis (WON)\n2. Eligible for EUS guided BFMS placement\n3. Signed informed consent .\n4. Age \\>18 Years\n\nExclusion Criteria:\n\n1. Types of pancreatic collections other than WON .\n2. Drainage with stents other than BFMS\n3. Previous attempts at drainage of WON\n4. Coagulopathy (INR\\>1.5) or thrombocytopenia(plc \\<50000/cmm)- not correctable.\n5. Pregnancy\n6. Not willing to give informed consent'}, 'identificationModule': {'nctId': 'NCT05632900', 'acronym': 'BFMSP', 'briefTitle': 'COMPARISON OF OUTCOMES OF BI-FLANGED METAL STENT ALONE VERSUS BI-FLANGED METAL STENT WITH CO-AXIAL PLASTIC STENT FOR DRAINAGE OF WALLED-OFF PANCREATIC NECROSIS - A PROSPECTIVE RANDOMISED CONTROLLED STUDY.', 'organization': {'class': 'OTHER', 'fullName': 'Asian Institute of Gastroenterology, India'}, 'officialTitle': 'COMPARISON OF OUTCOMES OF BI-FLANGED METAL STENT ALONE VERSUS BI-FLANGED METAL STENT WITH CO-AXIAL PLASTIC STENT FOR DRAINAGE OF WALLED-OFF PANCREATIC NECROSIS', 'orgStudyIdInfo': {'id': 'BFMSP -001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NAGI BI-FLANGED METAL STENT WITH CO-AXIAL PLASTIC STENT FOR DRAINAGE OF WOPN.', 'description': 'Endoscopic ultrasound guided drainage -Nagi Bi Flanged metal stent--16mm diameter 2cm long with co Axial double pig tail stent used for drainage of walled of necrosis. Intra and post prodecural complications will be noted, a plane CT screening abdomen will be performed with in 48 to 72 hours to document the size of collection.', 'interventionNames': ['Procedure: Endoscopic ultrasound guided drainage of walled off pancreatic necrosis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NAGI BI-FLANGED METAL STENT ALONE FOR DRAINAGE OF WOPN.', 'description': 'Endoscopic ultrasound guided drainage -Nagi Bi Flanged metal stent--16mm diameter 2cm long used for drainage of walled of necrosis. Intra and post prodecural complications will be noted, a plane CT screening abdomen will be performed with in 48 to 72 hours to document the size of collection.', 'interventionNames': ['Procedure: Endoscopic ultrasound guided drainage of walled off pancreatic necrosis']}], 'interventions': [{'name': 'Endoscopic ultrasound guided drainage of walled off pancreatic necrosis', 'type': 'PROCEDURE', 'description': 'It is Therapeutic procedure to treat walled off pancreatic necrosis.', 'armGroupLabels': ['NAGI BI-FLANGED METAL STENT ALONE FOR DRAINAGE OF WOPN.', 'NAGI BI-FLANGED METAL STENT WITH CO-AXIAL PLASTIC STENT FOR DRAINAGE OF WOPN.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '500082', 'city': 'Hyderabad', 'state': 'Telangana', 'country': 'India', 'facility': 'Dr Rajesh Gupta', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}], 'overallOfficials': [{'name': 'Rajesh Dr Gupta, MBBS MD DM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asian Institute of Gastroenterology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asian Institute of Gastroenterology, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Mohan Ramchandani', 'investigatorAffiliation': 'Asian Institute of Gastroenterology, India'}}}}