Gastrointestinal Hemorrhage Clinical Trial
Official title:
Capsule Endoscopy or Mesenteric Angiogram in Patients With Overt Gastrointestinal Bleeding of Obscure Origin: A Randomized Study
Verified date | May 2008 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | Hong Kong: Department of Health |
Study type | Interventional |
To compare the diagnostic yield of mesenteric angiogram with CE in patients with active obscure GIB.
Status | Completed |
Enrollment | 58 |
Est. completion date | March 2008 |
Est. primary completion date | November 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - All patients admitted to PWH medical or surgical wards with melena or hematochezia in whom OGD and colonoscopy fail to identify site of bleeding. - Normal or non-diagnostic OGD and colonoscopy - Informed consent - Patients presented with shock will be resuscitated for urgent endoscopy Exclusion Criteria: - Patients remained in shock despite resuscitation. - Moribund patients - Terminal malignancy - Presence of pacemaker or ICD - Suspected or confirmed intestinal obstruction - Swallowing difficulties - Renal failure that preclude angiographic examination - Pregnancy - Age <18 - Refused consent |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
China | Endoscopy Center, Prince of Wales Hospital | Hong Kong(SAR) |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic yield of CE and mesenteric angiogram as the primary investigation after negative EGD and colonoscopy. | 12 months | No | |
Secondary | Percentage of patients with definitive diagnoses achieved;Length of stay (days) ;Transfusion requirements;No. of additional investigations (endoscopies, radiological investigation, CE etc);No. of patients requiring surgery ;12-month rebleeding rate | 12 months | No |
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