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

Not Applicable

Terminated

• Conditions: Peptic Ulcer; Bleeding
• Interventions: Procedure: Trans-catheter arterial embolization; Procedure: Surgery

• Registration Number: NCT00766961
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2008-10-03
• Study First Submitted QC: 2008-10-03
• Study First Posted: 2008-10-06
• Primary Completion: 2017-03
• Study Completion: 2017-12
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-21
• Last Update Posted: 2020-06-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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).

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Exclusion Criteria

• Refusal to participate in trial
• No consent
• Age < 18
• Pregnancy
• Moribund patients
• Patients with terminal malignancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAE group	Trans-catheter arterial embolization	Trans-catheter arterial embolization
Surgery group	Surgery	Surgery

Primary Outcome Measures

Name	Time	Method
Mortality within 30 days of randomization	30 days	Mortality within 30 days of randomization

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Endoscopy Center, Prince of Wales Hospital; 🇨🇳 Hong Kong, China