TAE and Surgery in Patients With Peptic Ulcer Bleeding Uncontrolled by Endoscopic Therapy
This study is currently recruiting participants.
Verified August 2012 by Chinese University of Hong Kong
Sponsor:
Chinese University of Hong Kong
Collaborators:
Karolinska University Hospital
Erasme University Hospital
Information provided by (Responsible Party):
James Yun-wong Lau, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00766961
First received: October 3, 2008
Last updated: August 27, 2012
Last verified: August 2012
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Purpose
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 Procedure: Surgery |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Comparison of Trans-catheter Arterial Embolization (TAE) and Surgery in Patients With Major Peptic Ulcer Bleeding Uncontrolled by Endoscopic Therapy |
Resource links provided by NLM:
Further study details as provided by Chinese University of Hong Kong:
Primary Outcome Measures:
- Mortality within 30 days of randomization [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Recurrent bleeding after assigned treatment [ Time Frame: 60 days ] [ Designated as safety issue: No ]
- The need for additional intervention either in the form of interventional radiology [ Time Frame: 60 days ] [ Designated as safety issue: No ]
- Post procedural morbidities [ Time Frame: 60 days ] [ Designated as safety issue: No ]
- The need for additional intervention either in the form of surgery [ Time Frame: 60 days ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Active Comparator: TAE group
Trans-catheter arterial embolization
|
Procedure: Trans-catheter arterial embolization
Trans-catheter arterial embolization
Other Name: TAE
|
|
Active Comparator: Surgery group
Surgery
|
Procedure: Surgery
Surgery
Other Name: Surgery
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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).
Exclusion Criteria:
- Refusal to participate in trial
- No consent
- Age < 18
- Pregnancy
- Moribund patients
- Patients with terminal malignancy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00766961
Contacts
| Contact: James YW LAU, MD | (852) 26321411 | laujyw@surgery.cuhk.edu.hk |
| Contact: Kim WL AU, MSc | (852) 26322640 | kimau@surgery.cuhk.edu.hk |
Locations
| China | |
| Endoscopy Center, Prince of Wales Hospital | Recruiting |
| Hong Kong (SAR), China | |
| Contact: James YW Lau, MD 852 2632 1411 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 | |
Sponsors and Collaborators
Chinese University of Hong Kong
Karolinska University Hospital
Erasme University Hospital
Investigators
| Principal Investigator: | James YW LAU, MD | Chinese University of Hong Kong |
More Information
No publications provided
| Responsible Party: | James Yun-wong Lau, Professor, Chinese University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT00766961 History of Changes |
| Other Study ID Numbers: | TAE |
| Study First Received: | October 3, 2008 |
| Last Updated: | August 27, 2012 |
| Health Authority: | Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee |
Keywords provided by Chinese University of Hong Kong:
|
Peptic ulcer bleeding uncontrolled by endoscopic therapy. |
Additional relevant MeSH terms:
|
Hemorrhage Peptic Ulcer Peptic Ulcer Hemorrhage Ulcer Pathologic Processes Duodenal Diseases |
Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Stomach Diseases Gastrointestinal Hemorrhage |
ClinicalTrials.gov processed this record on May 23, 2013