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TAE and Surgery in Patients With Peptic Ulcer Bleeding Uncontrolled by Endoscopic Therapy

This study is currently recruiting participants.
Verified December 2016 by James Yun-wong Lau, Chinese University of Hong Kong
Sponsor:
ClinicalTrials.gov Identifier:
NCT00766961
First Posted: October 6, 2008
Last Update Posted: December 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Karolinska University Hospital
Erasme University Hospital
King Chulalongkorn Memorial Hospital
Information provided by (Responsible Party):
James Yun-wong Lau, Chinese University of Hong Kong
  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
Intervention Model: Parallel Assignment
Masking: None (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 James Yun-wong Lau, Chinese University of Hong Kong:

Primary Outcome Measures:
  • Mortality within 30 days of randomization [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • Recurrent bleeding after assigned treatment [ Time Frame: 60 days ]
  • The need for additional intervention either in the form of interventional radiology [ Time Frame: 60 days ]
  • Post procedural morbidities [ Time Frame: 60 days ]
  • The need for additional intervention either in the form of surgery [ Time Frame: 60 days ]

Estimated Enrollment: 184
Study Start Date: April 2007
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
King Chulalongkorn Memorial Hospital
Investigators
Principal Investigator: James YW LAU, MD Chinese University of Hong Kong
  More Information

Responsible Party: James Yun-wong Lau, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00766961     History of Changes
Other Study ID Numbers: TAE
First Submitted: October 3, 2008
First Posted: October 6, 2008
Last Update Posted: December 23, 2016
Last Verified: December 2016

Keywords provided by James Yun-wong Lau, Chinese University of Hong Kong:
Peptic ulcer bleeding uncontrolled by endoscopic therapy.

Additional relevant MeSH terms:
Peptic Ulcer
Peptic Ulcer Hemorrhage
Ulcer
Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage