Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2026-02-21 @ 6:44 PM
Study NCT ID:
NCT00766961
Status:
TERMINATED
Last Update Posted:
2020-06-23
First Post:
2008-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TAE and Surgery in Patients With Peptic Ulcer Bleeding Uncontrolled by Endoscopic Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'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': 34}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-21', 'studyFirstSubmitDate': '2008-10-03', 'studyFirstSubmitQcDate': '2008-10-03', 'lastUpdatePostDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality within 30 days of randomization', 'timeFrame': '30 days', 'description': 'Mortality within 30 days of randomization'}], 'secondaryOutcomes': [{'measure': 'Recurrent bleeding after assigned treatment', 'timeFrame': '60 days', 'description': 'Recurrent bleeding after assigned treatment'}, {'measure': 'The need for additional intervention either in the form of interventional radiology', 'timeFrame': '60 days', 'description': 'The need for additional intervention either in the form of interventional radiology'}, {'measure': 'Post procedural morbidities', 'timeFrame': '60 days', 'description': 'Post procedural morbidities'}, {'measure': 'The need for additional intervention either in the form of surgery', 'timeFrame': '60 days', 'description': 'The need for additional intervention either in the form of surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Peptic ulcer bleeding uncontrolled by endoscopic therapy.'], 'conditions': ['Peptic Ulcer', 'Bleeding']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the outcomes of trans-catheter arterial embolization (TAE) and surgery as salvage therapy of peptic ulcer bleeding after failed endoscopic therapy.', 'detailedDescription': 'The aim of the study is to examine the hypothesis that trans-catheter arterial embolization (TAE) is safer than and probably as effective as surgery in the control of bleeding from ulcers after failed endoscopic therapy. Patients with major arterial bleeding that cannot be stopped by endoscopic therapy will be randomly assigned to receive immediate TAE or surgery. Primary outcome will be death within 30 days of randomization. Secondary outcomes include recurrent bleeding after assigned treatment, need for additional intervention either in the form of interventional radiology or surgery, and post procedural morbidities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with bleeding peptic ulcers documented during endoscopic therapy AND anyone of the following:\n* Forrest I bleeding that fails to be controlled by therapy during first endoscopy\n* Check endoscopy after clinical re-bleeding of Forrest I bleeding\n* Forrest IIa or an initial IIb but a sizable artery unveiled upon clot elevation in a high risk ulcer defined by:\n* posterior bulbar duodenal ulcer \\> 2cm, or\n* an angular notch / lesser curve gastric ulcer \\> 5cm that fail an attempt at endoscopic therapy together with evidence of a significant bleed (hypotension with SBP \\< 90mmHg, fresh hematemesis or hematochezia).\n\nExclusion Criteria:\n\n* Refusal to participate in trial\n* No consent\n* Age \\< 18\n* Pregnancy\n* Moribund patients\n* Patients with terminal malignancy'}, 'identificationModule': {'nctId': 'NCT00766961', 'briefTitle': 'TAE and Surgery in Patients With Peptic Ulcer Bleeding Uncontrolled by Endoscopic Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Randomized Comparison of Trans-catheter Arterial Embolization (TAE) and Surgery in Patients With Major Peptic Ulcer Bleeding Uncontrolled by Endoscopic Therapy', 'orgStudyIdInfo': {'id': 'TAE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TAE group', 'description': 'Trans-catheter arterial embolization', 'interventionNames': ['Procedure: Trans-catheter arterial embolization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgery group', 'description': 'Surgery', 'interventionNames': ['Procedure: Surgery']}], 'interventions': [{'name': 'Trans-catheter arterial embolization', 'type': 'PROCEDURE', 'otherNames': ['TAE'], 'description': 'Trans-catheter arterial embolization', 'armGroupLabels': ['TAE group']}, {'name': 'Surgery', 'type': 'PROCEDURE', 'description': 'Surgery', 'armGroupLabels': ['Surgery group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'China', 'facility': 'Endoscopy Center, Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'James YW LAU, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska University Hospital', 'class': 'OTHER'}, {'name': 'Erasme University Hospital', 'class': 'OTHER'}, {'name': 'King Chulalongkorn Memorial Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'James Yun-wong Lau', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}