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

June 21, 2020 updated by: James Yun-wong Lau, Chinese University of Hong Kong

Randomized Comparison of Trans-catheter Arterial Embolization (TAE) and Surgery in Patients With Major Peptic Ulcer Bleeding Uncontrolled by Endoscopic Therapy

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Endoscopy Center, Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: TAE group
Trans-catheter arterial embolization
Procedure: Trans-catheter arterial embolization
Trans-catheter arterial embolization
Other Names:
  • TAE
ACTIVE_COMPARATOR: Surgery group
Surgery
Procedure: Surgery
Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality within 30 days of randomization
Time Frame: 30 days
Mortality within 30 days of randomization
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent bleeding after assigned treatment
Time Frame: 60 days
Recurrent bleeding after assigned treatment
60 days
The need for additional intervention either in the form of interventional radiology
Time Frame: 60 days
The need for additional intervention either in the form of interventional radiology
60 days
Post procedural morbidities
Time Frame: 60 days
Post procedural morbidities
60 days
The need for additional intervention either in the form of surgery
Time Frame: 60 days
The need for additional intervention either in the form of surgery
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

Karolinska University Hospital
King Chulalongkorn Memorial Hospital
Erasme University Hospital

Investigators

  • Principal Investigator: James YW LAU, MD, Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

December 1, 2017

Study Registration Dates

First Submitted

October 3, 2008

First Submitted That Met QC Criteria

October 3, 2008

First Posted (ESTIMATE)

October 6, 2008

Study Record Updates

Last Update Posted (ACTUAL)

June 23, 2020

Last Update Submitted That Met QC Criteria

June 21, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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