Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-03-03 @ 6:36 AM
Study NCT ID:
NCT02053428
Status:
COMPLETED
Last Update Posted:
2014-11-17
First Post:
2014-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Percutaneous Image-guided Gastrostomies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-14', 'studyFirstSubmitDate': '2014-01-21', 'studyFirstSubmitQcDate': '2014-01-31', 'lastUpdatePostDateStruct': {'date': '2014-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain experience', 'timeFrame': 'pre, 1-hour, 2-hour, 3-hour, 1-day, 2-day, 3-day and weekly for up to six weeks post procedure', 'description': 'The primary objective of this study is to compare the level of pain experienced, measured by the dose of sedation used during the procedure, and numerical rating scale (NRS)'}], 'secondaryOutcomes': [{'measure': 'Technical success', 'timeFrame': 'Day 0 post procedure', 'description': 'successful placement of percutaneous image-guided gastrostomy'}, {'measure': 'Catheter malfunction rate', 'timeFrame': 'Up to six months post procedure', 'description': 'tube clogging, dislodgement and/or leakage'}, {'measure': 'Tube site complications', 'timeFrame': 'Up to six months post procedure', 'description': 'Skin infection on tube exit'}, {'measure': 'Quality of life', 'timeFrame': 'Up to six weeks post procedure', 'description': 'Quality of life for patients undergoing different types of PIG procedures.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Head and neck cancer', 'Percutaneous image-guided gastrostomy', 'Pain', 'Quality of life', 'Complication'], 'conditions': ['Cancer of Head and Neck']}, 'descriptionModule': {'briefSummary': 'Percutaneous image-guided gastrostomy (PIG) is an increasingly popular technique of creating gastroenteric access through the anterior abdominal wall for nutrition and/ or compression. Large-bore mushroom-retained catheters via the pull technique and small-bore cope loop catheters via the push technique are both used at Interventional Radiology for PIG at our institution. To date, there is no guideline for PIG and no direct comparison of two PIG techniques. The proposed pilot study is to compare the two different types of PIG techniques in head and neck cancer patients who require prophylactic enteral feeding by PIG. The purpose of the study is to assess the feasibility of a large randomized clinical trial to compare these two PIG techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female ≥18 years;\n2. Life expectancy \\> 6 months;\n3. Diagnosed with head and neck cancer; and\n4. Scheduled to have prophylactic enteral feeding by percutaneous image-guided gastrostomy performed in the interventional radiology suite.\n\nExclusion Criteria:\n\n1. Pregnancy; or\n2. Established pharyngeal obstruction and/or presence of an enteral feeding device.'}, 'identificationModule': {'nctId': 'NCT02053428', 'briefTitle': 'Comparison of Percutaneous Image-guided Gastrostomies', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Comparison of Percutaneous Image-guided Gastrostomies: A Single Centre Pilot Study', 'orgStudyIdInfo': {'id': '12-0298B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Gastrostomy - pull technique', 'description': 'Percutaneous image-guided gastrostomy using large-bore mushroom-retained catheters via the pull technique', 'interventionNames': ['Procedure: percutaneous image-guided gastrostomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gastrostomy - push technique', 'description': 'Percutaneous image-guided gastrostomy using small-bore cope loop catheters via the push technique', 'interventionNames': ['Procedure: percutaneous image-guided gastrostomy']}], 'interventions': [{'name': 'percutaneous image-guided gastrostomy', 'type': 'PROCEDURE', 'armGroupLabels': ['Gastrostomy - pull technique', 'Gastrostomy - push technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2N2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Kong Teng Tan, MB BCH BAO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}