Peptic UlcerNCT00766961
TAE and Surgery in Patients With Peptic Ulcer Bleeding Uncontrolled by Endoscopic Therapy
A study testing Trans-catheter arterial embolization and Surgery in people with Peptic Ulcer and Bleeding, run by Chinese University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peptic Ulcer, Bleeding
- What is being tested?
- Trans-catheter arterial embolization and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- Apr 2007to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Refusal to participate in trial
- No consent
- Age < 18
- Pregnancy
- Moribund patients
- Patients with terminal malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Peptic Ulcer, Bleeding
- Being tested
- Trans-catheter arterial embolization, Surgery
- Keywords
- Peptic ulcer bleeding uncontrolled by endoscopic therapy.
- Medical subject headings
- Peptic Ulcer, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-catheter arterial embolizationProcedure or surgery
Also called TAE
Trans-catheter arterial embolization
SurgeryProcedure or surgery
Surgery
| Study group | Role | What they receive |
|---|---|---|
| TAE group | Active comparator | Trans-catheter arterial embolization Receives: Procedure: Trans-catheter arterial embolization |
| Surgery group | Active comparator | Surgery Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality within 30 days of randomization
Mortality within 30 days of randomization
Measured: 30 days
Secondary outcomes (4)
Recurrent bleeding after assigned treatment
Recurrent bleeding after assigned treatment
Measured: 60 days
The need for additional intervention either in the form of interventional radiology
The need for additional intervention either in the form of interventional radiology
Measured: 60 days
Post procedural morbidities
Post procedural morbidities
Measured: 60 days
The need for additional intervention either in the form of surgery
The need for additional intervention either in the form of surgery
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2008 (estimated)
- Study startApr 2007
- Primary completionMar 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic UlcerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, Erasme University Hospital, King Chulalongkorn Memorial Hospital
- Responsible party
- Principal investigator, James Yun-wong Lau, Chinese University of Hong Kong
- Investigators
- James YW LAU, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766961
- Sponsor's protocol ID
- TAE
- Status last verified
- Jun 2020
- First submitted
- 3 Oct 2008
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Trans-catheter Arterial Embolization (TAE) and Surgery in Patients With Major Peptic Ulcer Bleeding Uncontrolled by Endoscopic Therapy
- ClinicalTrials.gov ID
- NCT00766961
- Acronym / sponsor ID
- TAE
- Conditions
- Peptic Ulcer, Bleeding
- Keywords
- Peptic ulcer bleeding uncontrolled by endoscopic therapy.
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, Erasme University Hospital, King Chulalongkorn Memorial Hospital
- Study start
- Apr 2007
- Primary completion
- Mar 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 6 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAE group | Active comparator | Procedure: Trans-catheter arterial embolizationTrans-catheter arterial embolization |
| Surgery group | Active comparator | Procedure: SurgerySurgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Refusal to participate in trial
- No consent
- Age < 18
- Pregnancy
- Moribund patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trans-catheter arterial embolizationAlso: TAETrans-catheter arterial embolization | Procedure or surgery | TAE group |
| SurgerySurgery | Procedure or surgery | Surgery group |
Primary outcome
Mortality within 30 days of randomization
Time frame: 30 days
Mortality within 30 days of randomization
4 secondary outcomes
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James YW LAU, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-catheter arterial embolization and Surgery in people with Peptic Ulcer and Bleeding, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality within 30 days of randomization (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2020.