Trans-Catheter Arterial Embolization and Surgery in Patients With Peptic Ulcer Bleeding Uncontrolled by Endoscopic Therapy - Full Text View

Sponsored by:	Chinese University of Hong Kong
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00766961

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 or surgery

MedlinePlus related topics: Endoscopy Peptic Ulcer

U.S. FDA Resources

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

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:

Subject is died within 30 days of randomization [ Time Frame: 30 days ]

Secondary Outcome Measures:

Recurrent bleeding after assigned treatment, need for additional intervention either in the form of interventional radiology or surgery, and post procedural morbidities. [ Time Frame: 60 days ]

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	Procedure: Trans-catheter arterial embolization or surgery Trans-catheter arterial embolization versus Surgery
Surgery: Active Comparator Surgery	Procedure: Trans-catheter arterial embolization or surgery Trans-catheter arterial embolization versus 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) 26322789	laujyw@surgery.cuhk.edu.hk
Contact: Kim WL AU, BSc	(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 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

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

Principal Investigator:

James YW LAU, MD

Chinese University of Hong Kong

More Information

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

Keywords provided by Chinese University of Hong Kong:

Peptic ulcer bleeding uncontrolled by endoscopic therapy.

Study placed in the following topic categories:

Stomach Diseases
Digestive System Diseases
Gastrointestinal Diseases
Ulcer

Intestinal Diseases
Hemorrhage
Duodenal Diseases
Peptic Ulcer

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009