TAE and Surgery in Patients With Peptic Ulcer Bleeding Uncontrolled by Endoscopic Therapy
Randomized Comparison of Trans-catheter Arterial Embolization (TAE) and Surgery in Patients With Major Peptic Ulcer Bleeding Uncontrolled by Endoscopic Therapy
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 3, 2008
CompletedFirst Posted
Study publicly available on registry
October 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJune 23, 2020
June 1, 2020
9.9 years
October 3, 2008
June 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality within 30 days of randomization
Mortality within 30 days of randomization
30 days
Secondary Outcomes (4)
Recurrent bleeding after assigned treatment
60 days
The need for additional intervention either in the form of interventional radiology
60 days
Post procedural morbidities
60 days
The need for additional intervention either in the form of surgery
60 days
Study Arms (2)
TAE group
ACTIVE COMPARATORTrans-catheter arterial embolization
Surgery group
ACTIVE COMPARATORSurgery
Interventions
Trans-catheter arterial embolization
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Refusal to participate in trial
- No consent
- Age \< 18
- Pregnancy
- Moribund patients
- Patients with terminal malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chinese University of Hong Konglead
- Karolinska University Hospitalcollaborator
- Erasme University Hospitalcollaborator
- King Chulalongkorn Memorial Hospitalcollaborator
Study Sites (1)
Endoscopy Center, Prince of Wales Hospital
Hong Kong, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James YW LAU, MD
Chinese University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 3, 2008
First Posted
October 6, 2008
Study Start
April 1, 2007
Primary Completion
March 1, 2017
Study Completion
December 1, 2017
Last Updated
June 23, 2020
Record last verified: 2020-06