Bleeding, Peptic Ulcer
Conditions
Keywords
Peptic ulcer bleeding uncontrolled by endoscopic therapy.
Brief summary
The aim of the study is to compare the outcomes of trans-catheter arterial embolization (TAE) and surgery as salvage therapy of peptic ulcer bleeding after failed endoscopic therapy.
Detailed description
The aim of the study is to examine the hypothesis that trans-catheter arterial embolization (TAE) is safer than and probably as effective as surgery in the control of bleeding from ulcers after failed endoscopic therapy. Patients with major arterial bleeding that cannot be stopped by endoscopic therapy will be randomly assigned to receive immediate TAE or surgery. Primary outcome will be death within 30 days of randomization. Secondary outcomes include recurrent bleeding after assigned treatment, need for additional intervention either in the form of interventional radiology or surgery, and post procedural morbidities.
Interventions
PROCEDURETrans-catheter arterial embolization
Trans-catheter arterial embolization
PROCEDURESurgery
Surgery
Sponsors
Karolinska University Hospital
Erasme University Hospital
King Chulalongkorn Memorial Hospital
Chinese University of Hong Kong
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
* Patients with bleeding peptic ulcers documented during endoscopic therapy AND anyone of the following: * Forrest I bleeding that fails to be controlled by therapy during first endoscopy * Check endoscopy after clinical re-bleeding of Forrest I bleeding * Forrest IIa or an initial IIb but a sizable artery unveiled upon clot elevation in a high risk ulcer defined by: * posterior bulbar duodenal ulcer \> 2cm, or * an angular notch / lesser curve gastric ulcer \> 5cm that fail an attempt at endoscopic therapy together with evidence of a significant bleed (hypotension with SBP \< 90mmHg, fresh hematemesis or hematochezia).
Exclusion criteria
* Refusal to participate in trial * No consent * Age \< 18 * Pregnancy * Moribund patients * Patients with terminal malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality within 30 days of randomization | 30 days | Mortality within 30 days of randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent bleeding after assigned treatment | 60 days | Recurrent bleeding after assigned treatment |
| The need for additional intervention either in the form of interventional radiology | 60 days | The need for additional intervention either in the form of interventional radiology |
| Post procedural morbidities | 60 days | Post procedural morbidities |
| The need for additional intervention either in the form of surgery | 60 days | The need for additional intervention either in the form of surgery |
Countries
China
Outcome results
None listed