Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT00164905
Status:
TERMINATED
Last Update Posted:
2012-08-28
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010438', 'term': 'Peptic Ulcer Hemorrhage'}], 'ancestors': [{'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'whyStopped': 'Slow recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-27', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2012-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrent bleeding', 'timeFrame': 'Within 30 days'}], 'secondaryOutcomes': [{'measure': 'Length of stay', 'timeFrame': 'Within 56 days'}, {'measure': 'ICU utilization', 'timeFrame': 'Within 56 days'}, {'measure': 'Blood Transfusion during hospital', 'timeFrame': 'Within 56 days'}, {'measure': 'Need for urgent/emergent ulcer surgery for bleeding', 'timeFrame': 'Within 56 days'}, {'measure': 'Need for angiographic treatment of bleeding', 'timeFrame': 'Within 56 days'}, {'measure': 'Death', 'timeFrame': 'within 56 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Peptic ulcer hemorrhage', 'Doppler ultrasound'], 'conditions': ['Peptic Ulcer Hemorrhage']}, 'descriptionModule': {'briefSummary': 'The aim of study is to evaluate whether Doppler ultrasound can accurately identify patients who are at risk of recurrent bleeding, who will require endoscopic therapy, and who will fail endoscopic therapy.', 'detailedDescription': "Bleeding peptic ulcer is a life-threatening emergency. Endoscopic therapy is a proven technique in the acute hemostasis of bleeding ulcers. Currently there is no objective assessment of adequacy of endoscopic therapy. Endoscopic Doppler ultrasound enables endoscopists in detecting blood flow in a vessel beneath an ulcer. A persistent signal after endoscopic therapy predicts recurrent bleeding. The current study proposes to compare assessment of ulcer base using either Doppler ultrasound or endoscopists' interpretation of ulcer floors. The trial design is one of a prospective randomized controlled cross-over study in which patients with severe upper gastrointestinal bleeding and documented peptic ulcers at endoscopy are enrolled."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clean base ulcer with severe upper GIB (defined as melaena, hematochezia, hematemesis, and/or gross blood in NG lavage), and any one of the following:\n\n 1. SBP ≤ 90mmHg; P of ≥110 bpm; or orthostatic changes with SBP drops 20mmHg or P increases 20 bpm; or,\n 2. Transfusion of 2 or more units of packed red blood cells within 12 hrs of admission; or,\n 3. A documented HCT drop of at lest 6% from baseline.\n* Endoscopically confirmed bleeding from GU, DU, pyloric ulcer, or anastomotic ulcer\n* Pt can either have primary or secondary acute UGI haemorrhage\n\nExclusion Criteria:\n\n* Bleeding site from lesion other than GU, DU, pyloric or anastomotic ulcer\n* there is more than one type of significant bleeding lesion\n* Documented hx of cirrhosis / portal HT\n* ESRF requiring any form of dialysis\n* Expected or persistent (\\>24hrs) coagulopathy with INR\\> 1.5\n* Platelet count is under 50000/mm3\n* Aspirin User / Plavix \\[Clopidogrel\\] User\n* If the ulcer is neoplastic\n* Cannot obtained consent\n* Age \\< 18 or is pregnant\n* Severe comorbid of which life expectancy \\<30 days'}, 'identificationModule': {'nctId': 'NCT00164905', 'briefTitle': 'Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage: Can it Guide the Use of and Predict Failure of Endoscopic Treatment? A Prospective, Multicenter, Randomized, Controlled Study', 'orgStudyIdInfo': {'id': 'DOP-US study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Doppler ultrasound', 'interventionNames': ['Device: Doppler ultrasound probe']}, {'type': 'NO_INTERVENTION', 'label': 'No Doppler ultrasound'}], 'interventions': [{'name': 'Doppler ultrasound probe', 'type': 'DEVICE', 'otherNames': ['DOP_US'], 'description': 'Applying to ulcer base to assess the blood flow underneath the ulcer', 'armGroupLabels': ['Doppler ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong SAR', 'country': 'China', 'facility': 'Endoscopy Center, Prince of Wales Hospital'}], 'overallOfficials': [{'name': 'James Y Lau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prince of Wales Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'James Yun-wong Lau', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}