Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-30 @ 6:13 PM
Study NCT ID:
NCT04602156
Status:
COMPLETED
Last Update Posted:
2022-11-23
First Post:
2020-10-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002764', 'term': 'Cholecystitis'}], 'ancestors': [{'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-22', 'studyFirstSubmitDate': '2020-10-20', 'studyFirstSubmitQcDate': '2020-10-20', 'lastUpdatePostDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical success', 'timeFrame': 'At the end of the procedure', 'description': 'Image verified catheter placement within the gallbladder and subsequent bile aspiration'}, {'measure': 'Procedure-related complications', 'timeFrame': '3 months', 'description': 'Minor or major complications attributed to the procedure'}], 'secondaryOutcomes': [{'measure': 'Duration of the procedure', 'timeFrame': 'Intraprocedural', 'description': 'The time period between administration of local anesthesia and pigtail catheter positioning within the gallbladder'}, {'measure': 'Intraprocedural pain', 'timeFrame': 'End of the procedure', 'description': 'pain experienced during the procedure assessed using a standard visual analogue score the procedure, as assessed using a standard visual analog score'}, {'measure': 'Post-procedural pain', 'timeFrame': '12 hours', 'description': 'Pain experienced up to12 hours after procedure assessed using a standard visual analogue score (VAS - Visual Analog Scale 0-10, 0 representing no pain \\& 10 representing worst pain experienced)'}, {'measure': 'Clinical success', 'timeFrame': '72 hours', 'description': 'Gradual subsidence of signs, symptoms, and elevated inflammatory markers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Percutaneous cholecystostomy', 'ultrasound-guided', 'interventional radiology', 'Trocar', 'Seldinger'], 'conditions': ['Cholecystitis']}, 'descriptionModule': {'briefSummary': 'A single-center randomized comparison of bedside ultrasound (US)-guided trocar technique versus the US-guided Seldinger technique for percutaneous cholecystostomy', 'detailedDescription': 'This is a single-center, randomized, controlled trial (RCT), comparing bedside US-guided trocar technique versus the US-guided Seldinger technique for percutaneous cholecystostomy (PC). The study will randomize a total of 100 consecutive patients (50 in each group) undergoing PC at one large tertiary university hospital. The primary endpoints will be technical success and procedure-related complication rates. Secondary endpoints will be procedural duration, pain assessment, and clinical success after up to 3 months of follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients requiring PC, regardless of the underlying cause.\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Age \\<18 years or \\>100 years\n* The necessity for CT-guided PC catheter placement, according to the judgment of the performing physician\n* Severe uncontrollable coagulopathy'}, 'identificationModule': {'nctId': 'NCT04602156', 'acronym': 'TROSELCII', 'briefTitle': 'US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy', 'organization': {'class': 'OTHER', 'fullName': 'Attikon Hospital'}, 'officialTitle': 'Randomized Comparison of US-guided TROcar Versus SELdiger Technique for Percutaneous Cholecystostomy. The TROSELC II Trial.', 'orgStudyIdInfo': {'id': 'EBD 515/16-9-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group T', 'description': 'Patients will be randomized to undergo PC catheter placement (8-French) using the trocar method under US guidance while receiving local anesthesia and opioid analgesic, in a bedside setting, either in the US room or in the ICU.', 'interventionNames': ['Procedure: Trocar percutaneous cholecystostomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group S', 'description': 'Patients will be randomized to undergo PC catheter placement (8-French) using the Sellinger method under US guidance while receiving local anesthesia and opioid analgesic, in a bedside setting, either in the US room or in the ICU.', 'interventionNames': ['Procedure: Seldinger percutaneous cholecystostomy']}], 'interventions': [{'name': 'Trocar percutaneous cholecystostomy', 'type': 'PROCEDURE', 'description': 'Percutaneous cholecystostomy using the one-step Trocar technique under US guidance. An 8Fr Trocar catheter will be inserted percutaneously within the gallbladder under real-time US guidance. The procedure will be performed using an aseptic technique, local anesthesia and intravenous opioid analgesia.', 'armGroupLabels': ['Group T']}, {'name': 'Seldinger percutaneous cholecystostomy', 'type': 'PROCEDURE', 'description': 'Percutaneous cholecystostomy using the Seldinger technique under US guidance. Following percutaneous puncture of the gallbladder with an 18G needle under real-time US guidance, an 8Fr catheter will be inserted percutaneously over the wire within the gallbladder under real-time US guidance. The procedure will be performed using an aseptic technique, local anesthesia and intravenous opioid analgesia.', 'armGroupLabels': ['Group S']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12461', 'city': 'Athens', 'state': 'Attica', 'country': 'Greece', 'facility': '"Attikon" University General Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'overallOfficials': [{'name': 'Stavros Spiliopoulos, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ATTIKO University Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD could be available after the completion of the study upon reasonable request', 'ipdSharing': 'YES', 'description': 'IPD could be available upon reasonable request', 'accessCriteria': 'email'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Attikon Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor in Interventional Radiology', 'investigatorFullName': 'Stavros Spiliopoulos', 'investigatorAffiliation': 'Attikon Hospital'}}}}