Supplementary Angiographic Embolization for Peptic Ulcer Bleeding: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Odense University Hospital
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- Composite Endpoint
Study Overview
Brief Summary
Peptic ulcer bleeding is a common disorder. Despite optimal endoscopic and medical treatment, there is a high risk of rebleeding and high mortality. In this study the investigators examine whether combined endoscopic haemostasis and angiographic embolization resolves in a better outcome than the traditional use of endoscopic haemostasis alone. The study is a randomised controlled trail.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical signs of upper GI-bleeding
- •Endoscopic verified high-risk ulcer (Forrest I-IIb)
- •Primary haemostasis achieved
Exclusion Criteria
- •Expected lifetime < 1 month
- •Upper GI-cancer found at endoscopy
Outcomes
Primary Outcomes
Composite Endpoint
Time Frame: Meassured after a week from primary therapeutic endoscopy
Patients are classified into groups depending on the worst outcome: 1. No clinical signs of rebleeding and requirement of two or less blood transfusions after circulatory stabilization and obtained hemoglobin \> 5,9mmol/L. 2. No clinical signs of rebleeding and requirement of more than two blood transfusions after circulatory stabilization and obtained hemoglobin \> 5,9mmol/L. 3. Rebleeding and achieved secondary haemostasis by endoscopy or angiographic embolization. 4. Rebleeding requiring surgery. 5. Patients who have died. Results are compared using the Wilcoxon rank sum test.
Secondary Outcomes
- Mortality(1 month)
- Rebleeding(1 month)
- Blood transfusion(1 month)
- Surgical haemostasis(1 month)
- Endoscopic/other haemostatic retreatment(1 month)
- Duration of hospitalization(Estimated 4 days)
- Thromboembolic complications(1 month)
Investigators
Stig Borbjerg Laursen
MD
Odense University Hospital