Peptic Ulcer Hemorrhage
Conditions
Keywords
Peptic ulcer hemorrhage, Peptic ulcer bleeding, Angiographic embolization, Arterial embolization, Angiography
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.
Interventions
PROCEDUREAngiographic embolization
Patients in the intervention arm receive supplementary angiographic embolization within 24 hours from the therapeutic endoscopy.
PROCEDURETherapeutic endoscopy
Patients are treated with standard therapeutic upper endoscopy including endoscopic combination therapy.
Sponsors
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Endpoint | 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
| Measure | Time frame | Description |
|---|---|---|
| Rebleeding | 1 month | Rebleeding from ulcer confirmed by endoscopy, angiography or surgery within a month from therapeutic endoscopy. |
| Blood transfusion | 1 month | Amount of received blood transfusions after circulatory stabilization and obtained hemoglobin \> 5,9mmol/L. Patients will only receive blood transfusion if hemoglobin \< 6,0mmol/L |
| Surgical haemostasis | 1 month | Rebleeding requiring surgical haemostasis within a month from therapeutic endoscopy. |
| Mortality | 1 month | Patients who have died within af month from therapeutic endoscopy. |
| Duration of hospitalization | Estimated 4 days | Time from hospitalization to discharge. |
| Thromboembolic complications | 1 month | Occurence of thromboembolic complications due to angiographic embolization, surgery or therapeutic endoscopy. |
| Endoscopic/other haemostatic retreatment | 1 month | Rebleeding confirmed by endoscopy or angiography and achieved secondary haemostasis by endoscopy or angiographic embolization. |
Countries
Denmark
Outcome results
None listed