TAE and Surgery in Patients With Peptic Ulcer Bleeding Uncontrolled by Endoscopic Therapy
Primary Purpose
Peptic Ulcer, Bleeding
Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Trans-catheter arterial embolization
Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Peptic Ulcer focused on measuring Peptic ulcer bleeding uncontrolled by endoscopic therapy.
Eligibility 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
Sites / Locations
- Endoscopy Center, Prince of Wales Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
TAE group
Surgery group
Arm Description
Trans-catheter arterial embolization
Surgery
Outcomes
Primary Outcome Measures
Mortality within 30 days of randomization
Mortality within 30 days of randomization
Secondary Outcome Measures
Recurrent bleeding after assigned treatment
Recurrent bleeding after assigned treatment
The need for additional intervention either in the form of interventional radiology
The need for additional intervention either in the form of interventional radiology
Post procedural morbidities
Post procedural morbidities
The need for additional intervention either in the form of surgery
The need for additional intervention either in the form of surgery
Full Information
NCT ID
NCT00766961
First Posted
October 3, 2008
Last Updated
June 21, 2020
Sponsor
Chinese University of Hong Kong
Collaborators
Karolinska University Hospital, Erasme University Hospital, King Chulalongkorn Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00766961
Brief Title
TAE and Surgery in Patients With Peptic Ulcer Bleeding Uncontrolled by Endoscopic Therapy
Official Title
Randomized Comparison of Trans-catheter Arterial Embolization (TAE) and Surgery in Patients With Major Peptic Ulcer Bleeding Uncontrolled by Endoscopic Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Study Start Date
April 2007 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
Karolinska University Hospital, Erasme University Hospital, King Chulalongkorn Memorial Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer, Bleeding
Keywords
Peptic ulcer bleeding uncontrolled by endoscopic therapy.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAE group
Arm Type
Active Comparator
Arm Description
Trans-catheter arterial embolization
Arm Title
Surgery group
Arm Type
Active Comparator
Arm Description
Surgery
Intervention Type
Procedure
Intervention Name(s)
Trans-catheter arterial embolization
Other Intervention Name(s)
TAE
Intervention Description
Trans-catheter arterial embolization
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Surgery
Primary Outcome Measure Information:
Title
Mortality within 30 days of randomization
Description
Mortality within 30 days of randomization
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Recurrent bleeding after assigned treatment
Description
Recurrent bleeding after assigned treatment
Time Frame
60 days
Title
The need for additional intervention either in the form of interventional radiology
Description
The need for additional intervention either in the form of interventional radiology
Time Frame
60 days
Title
Post procedural morbidities
Description
Post procedural morbidities
Time Frame
60 days
Title
The need for additional intervention either in the form of surgery
Description
The need for additional intervention either in the form of surgery
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James YW LAU, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endoscopy Center, Prince of Wales Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
TAE and Surgery in Patients With Peptic Ulcer Bleeding Uncontrolled by Endoscopic Therapy
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