TAE and Surgery in Patients With Peptic Ulcer Bleeding Uncontrolled by Endoscopic Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Comparison of Trans-catheter Arterial Embolization (TAE) and Surgery in Patients With Major Peptic Ulcer Bleeding Uncontrolled by Endoscopic Therapy

Conditions
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Peptic Ulcer, Bleeding

Intervention / Treatment
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* Procedure: Trans-catheter arterial embolization
* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TAE group<br>Trans-catheter arterial embolization | Procedure: Trans-catheter arterial embolization<br>* Trans-catheter arterial embolization<br>* Other names: TAE;|
| Active Comparator: Surgery group<br>Surgery | Procedure: Surgery<br>* Surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality within 30 days of randomization | Mortality within 30 days of randomization | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent bleeding after assigned treatment | Recurrent bleeding after assigned treatment | 60 days | 
| The need for additional intervention either in the form of interventional radiology | The need for additional intervention either in the form of interventional radiology | 60 days | 
| Post procedural morbidities | Post procedural morbidities | 60 days | 
| The need for additional intervention either in the form of surgery | The need for additional intervention either in the form of surgery | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peptic ulcer bleeding uncontrolled by endoscopic therapy.