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
Arms & Interventions
Intervention group
Patients in this group are treated with usual therapeutic endoscopy including endoscopic combination therapy and 72 hours intravenous proton pump inhibitor. Within 24 hours from the therapeutic endoscopy they receive supplementary angiographic embolization.
Intervention: Angiographic embolization (Procedure)
Control group
Patients in this arm receive standard treatment including therapeutic endoscopy with endoscopic combination therapy followed by 72 hours intravenous proton pump inhibitor.
Intervention: Therapeutic endoscopy (Procedure)
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