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Sponsored by: |
Chinese University of Hong Kong |
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Information provided by: | Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT00766961 |
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.
Condition | Intervention |
---|---|
Peptic Ulcer Bleeding |
Procedure: Trans-catheter arterial embolization or surgery |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Comparison of Trans-Catheter Arterial Embolization (TAE) and Surgery in Patients With Major Peptic Ulcer Bleeding Uncontrolled by Endoscopic Therapy |
Estimated Enrollment: | 184 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
TAE: Active Comparator
Trans-catheter arterial embolization
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Procedure: Trans-catheter arterial embolization or surgery
Trans-catheter arterial embolization versus Surgery
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Surgery: Active Comparator
Surgery
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Procedure: Trans-catheter arterial embolization or surgery
Trans-catheter arterial embolization versus Surgery
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: James YW LAU, MD | (852) 26322789 | laujyw@surgery.cuhk.edu.hk |
Contact: Kim WL AU, BSc | (852) 26322640 | kimau@surgery.cuhk.edu.hk |
China | |
Endoscopy Center, Prince of Wales Hospital | Recruiting |
Hong Kong (SAR), China | |
Contact: James YW Lau, MD 852 2632 2789 laujyw@surgery.cuhk.edu.hk | |
Sub-Investigator: Simon SS HO, MD | |
Sub-Investigator: Simon Yu, MD | |
Sub-Investigator: WK LEUNG, MD | |
Sub-Investigator: Enders KW NG, MD | |
Sub-Investigator: Philip WY CHIU, MD | |
Sub-Investigator: Francis KL CHAN, MD | |
Sub-Investigator: Joseph JY SUNG, MD |
Principal Investigator: | James YW LAU, MD | Chinese University of Hong Kong |
Study ID Numbers: | TAE |
Study First Received: | October 3, 2008 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00766961 |
Health Authority: | Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee |
Peptic ulcer bleeding uncontrolled by endoscopic therapy. |
Stomach Diseases Digestive System Diseases Gastrointestinal Diseases Ulcer |
Intestinal Diseases Hemorrhage Duodenal Diseases Peptic Ulcer |
Pathologic Processes |