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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2017-12-31

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.

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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.

Conditions

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Peptic Ulcer Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TAE group

Trans-catheter arterial embolization

Group Type ACTIVE_COMPARATOR

Trans-catheter arterial embolization

Intervention Type PROCEDURE

Trans-catheter arterial embolization

Surgery group

Surgery

Group Type ACTIVE_COMPARATOR

Surgery

Intervention Type PROCEDURE

Surgery

Interventions

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Trans-catheter arterial embolization

Intervention Type PROCEDURE

Surgery

Intervention Type PROCEDURE

Other Intervention Names

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TAE

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).