Status:
TERMINATED
TAE and Surgery in Patients With Peptic Ulcer Bleeding Uncontrolled by Endoscopic Therapy
Lead Sponsor:
Chinese University of Hong Kong
Collaborating Sponsors:
Karolinska University Hospital
Erasme University Hospital
Conditions:
Peptic Ulcer
Bleeding
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- Refusal to participate in trial
- No consent
- Age \< 18
- Pregnancy
- Moribund patients
- Patients with terminal malignancy
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00766961
Start Date
April 1 2007
End Date
December 1 2017
Last Update
June 23 2020
Active Locations (1)
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1
Endoscopy Center, Prince of Wales Hospital
Hong Kong, China