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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Chinese University of Hong Kong
Sponsor:
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: July 29, 2013
Last verified: July 2013
  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 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 29, 2013
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 July 31, 2014