Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-03-14 @ 9:46 AM
Study NCT ID:
NCT01584193
Status:
WITHDRAWN
Last Update Posted:
2018-10-23
First Post:
2012-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-guided Subclavian Vein Puncture Versus Cephalic Vein Dissection for Venous Access Port Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016748', 'term': 'Venous Cutdown'}], 'ancestors': [{'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Logistical reasons (institutional reorganization of ambulatory surgery)', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-22', 'studyFirstSubmitDate': '2012-04-21', 'studyFirstSubmitQcDate': '2012-04-21', 'lastUpdatePostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'surgical procedure time', 'timeFrame': 'during surgical procedure'}], 'secondaryOutcomes': [{'measure': 'primary implementation success rate', 'timeFrame': 'during surgical procedure'}, {'measure': 'overall implementation success rate', 'timeFrame': 'during surgical procedure'}, {'measure': 'technique conversion rate and causes', 'timeFrame': 'during surgical procedure'}, {'measure': 'pain during surgical procedure', 'timeFrame': 'during surgical procedure'}, {'measure': 'pain at 5 days', 'timeFrame': '5 days post-procedure'}, {'measure': 'Pain at 30 days', 'timeFrame': '30 days post-procedure'}, {'measure': 'Complications rate during surgical procedure', 'timeFrame': 'during surgical procedure', 'description': 'catheter malposition, hemorrhage, hemotoma, hemothorax, pneumothorax'}, {'measure': 'Complications rate at 5 days', 'timeFrame': '5 days post-procedure', 'description': 'hematoma, infection, symptomatic venous thrombosis, pneumothorax'}, {'measure': 'Complications rate at 30 days', 'timeFrame': '30 days post-procedure', 'description': 'infection, symptomatic venous thrombosis, pneumothorax, venous access port dysfunction'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['central venous access port', 'ultrasound-guided venous puncture', 'suclavian vein', 'cephalic vein'], 'conditions': ['Vascular Surgical Procedures']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare two different surgical techniques for implementation of totally implantable central venous access ports. Ultrasound-guided suclavian vein puncture is compared to cephalic vein dissection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18\n* Informed consent\n* Need for central venous access port implementation under local anesthesia\n\nExclusion Criteria:\n\n* Impaired blood clotting\n* Ongoing antiplatelet drugs therapy, except acetylsalicylic acid\n* Trauma or surgical past history on both shoulder girdles\n* Known central venous thrombosis (subclavian vein, upper vena cava)\n* Known pneumothorax\n* Septic state\n* Agranulocytosis'}, 'identificationModule': {'nctId': 'NCT01584193', 'briefTitle': 'Ultrasound-guided Subclavian Vein Puncture Versus Cephalic Vein Dissection for Venous Access Port Implantation', 'organization': {'class': 'OTHER', 'fullName': 'University of Lausanne Hospitals'}, 'officialTitle': 'Ultrasound-guided Subclavian Vein Puncture Versus Cephalic Vein Dissection for Totally Implantable Venous Access Port Implementation: a Single-center Controlled Randomized Superiority Trial', 'orgStudyIdInfo': {'id': 'CHV 46/11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'US-guided subclavian vein puncture', 'interventionNames': ['Procedure: Ultrasound-guided subclavian vein puncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cephalic vein dissection', 'interventionNames': ['Procedure: Cephalic vein dissection']}], 'interventions': [{'name': 'Ultrasound-guided subclavian vein puncture', 'type': 'PROCEDURE', 'otherNames': ['US-guided', 'Seldinger technique'], 'description': 'Central venous access port implementation through ultrasound-guided subclavian vein puncture and Seldinger technique', 'armGroupLabels': ['US-guided subclavian vein puncture']}, {'name': 'Cephalic vein dissection', 'type': 'PROCEDURE', 'otherNames': ['Venous cutdown'], 'description': 'Central venous access port implementation through cephalic vein dissection and cutdown', 'armGroupLabels': ['Cephalic vein dissection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'University Hospital Lausanne, Department of Visceral Surgery', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Nicolas Demartines', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Lausanne, Department of Visceral Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lausanne Hospitals', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Nicolas DEMARTINES', 'investigatorAffiliation': 'University of Lausanne Hospitals'}}}}