Peptic Ulcer BleedingNCT02434978
Doppler-guided Endoscopic Treatment in Peptic Ulcer Bleeding
A study testing Supplementary endoscopy with doppler-guided therapy, IV. PPI and Endoscopic treatment at primary endoscopy in people with Peptic Ulcer Bleeding, run by Odense University Hospital at 2 sites in Denmark.
Trial summary
The present study is a randomized controlled trial (RCT) that examines if the outcome of peptic ulcer bleeding could be improved by use of doppler-guided endoscopic treatment. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Peptic Ulcer Bleeding
- What is being tested?
- Supplementary endoscopy with doppler-guided therapy, IV. PPI and Endoscopic treatment at primary endoscopy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 2 sitesDenmark
- Study dates
- Jan 2014to Mar 2018
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Peptic ulcer bleeding from ulcers classified as Forrest I-IIb
Who cannot join
- Severe comorbidity with a remaining life expectancy below 30 days
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Department of gastrointestinal surgery, Aalborg University Hospital
Aalborg
Per Ejstrud, MD, +45 20645297, pee@rn.dk
- Recruiting
Department of gastroenterology, Odense University Hospital
Odense
Stig Laursen, MDPhD, +45 30207859, Stig.laursen@rsyd.dk
About this study
The present study is a randomized controlled trial (RCT) that examines if the outcome of peptic ulcer bleeding could be improved by use of doppler-guided endoscopic treatment.
Read the detailed description
This study evaluates if performance of a control endoscopy with doppler-guided endoscopic treatment is associated with an improved outcome in term of lower rate of rebleeding and lower rate of bleeding-related mortality. A potential risk of increased risk of complications (in particular perforation) among patients treated with control endoscopy is also evaluated. Outcomes are prospectively registered based on patient records.
- Conditions
- Peptic Ulcer Bleeding
- Being tested
- Supplementary endoscopy with doppler-guided therapy, IV. PPI, Endoscopic treatment at primary endoscopy
- 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.
Supplementary endoscopy with doppler-guided therapyDevice
Patients randomized to supplementary doppler-guided therapy undergo repeat endoscopy with doppler evaluation within 24 hours from the primary endoscopy. At the control endoscopy the ulcer base is examined using a doppler device. If active doppler flow is demonstrated the ulcer is treated with a thermal probe until a control doppler-scan is negative. All patients are observed for rebleeding at a specialized GI-bleeding unit.
IV. PPIDrug
All patients receive 80mg of Esomeprazole iv as a bolus followed by 8mg Esomeprazole per hour for 72 hours.
Endoscopic treatment at primary endoscopyOther
All patients are initially treated with endoscopic therapy using a minimum of two different treatment modalities. The primary endoscopy is performed wihtin 24 hours from time of admission to hospital
| Study group | Role | What they receive |
|---|---|---|
| Supplementary doppler-guided endoscopic therapy | Active comparator | Not described Receives: Device: Supplementary endoscopy with doppler-guided therapy; Drug: IV. PPI; Other: Endoscopic treatment at primary endoscopy |
| control group | Placebo comparator | Not described Receives: Drug: IV. PPI; Other: Endoscopic treatment at primary endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebleeding
Number of participants who develop symptoms of rebleeding combined with a significant drop in systolic blood pressure, or B-haemoglobin, or confirmation of stigmata of bleeding at repeat endoscopy/angiography/surgery.
Measured: 1 week
Secondary outcomes (2)
Bleeding-related mortality
Number of participants who die within 30 days from primary endoscopy because of severe rebleeding.
Measured: 1 month
Complications to endoscopic therapy
Number of participants who develop complications to applied endoscopic therapy.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startJan 2014
- Primary completionSep 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic Ulcer BleedingStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stig Borbjerg Laursen, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434978
- Sponsor's protocol ID
- S-20130140
- Status last verified
- Apr 2017
- First submitted
- 12 Nov 2014
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doppler-guided Endoscopic Treatment in Peptic Ulcer Bleeding
- ClinicalTrials.gov ID
- NCT02434978
- Acronym / sponsor ID
- S-20130140
- Conditions
- Peptic Ulcer Bleeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 6 May 2015 (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 present study is a randomized controlled trial (RCT) that examines if the outcome of peptic ulcer bleeding could be improved by use of doppler-guided endoscopic treatment.
Detailed description
This study evaluates if performance of a control endoscopy with doppler-guided endoscopic treatment is associated with an improved outcome in term of lower rate of rebleeding and lower rate of bleeding-related mortality. A potential risk of increased risk of complications (in particular perforation) among patients treated with control endoscopy is also evaluated. Outcomes are prospectively registered based on patient records.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplementary doppler-guided endoscopic therapy | Active comparator | Device: Supplementary endoscopy with doppler-guided therapy, Drug: IV. PPI, Other: Endoscopic treatment at primary endoscopy |
| control group | Placebo comparator | Drug: IV. PPI, Other: Endoscopic treatment at primary endoscopy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Peptic ulcer bleeding from ulcers classified as Forrest I-IIb
Key exclusion criteria (1 listed)
- Severe comorbidity with a remaining life expectancy below 30 days
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 |
|---|---|---|
| Supplementary endoscopy with doppler-guided therapyPatients randomized to supplementary doppler-guided therapy undergo repeat endoscopy with doppler evaluation within 24 hours from the primary endoscopy. At the control endoscopy the ulcer base is examined using a doppler device. If active doppler flow is demonstrated the ulcer is treated with a thermal probe until a control doppler-scan is negative. All patients are observed for rebleeding at a specialized GI-bleeding unit. | Device | Supplementary doppler-guided endoscopic therapy |
| IV. PPIAll patients receive 80mg of Esomeprazole iv as a bolus followed by 8mg Esomeprazole per hour for 72 hours. | Drug | Supplementary doppler-guided endoscopic therapy, control group |
| Endoscopic treatment at primary endoscopyAll patients are initially treated with endoscopic therapy using a minimum of two different treatment modalities. The primary endoscopy is performed wihtin 24 hours from time of admission to hospital | Other | Supplementary doppler-guided endoscopic therapy, control group |
Primary outcome
Rebleeding
Time frame: 1 week
Number of participants who develop symptoms of rebleeding combined with a significant drop in systolic blood pressure, or B-haemoglobin, or confirmation of stigmata of bleeding at repeat endoscopy/angiography/surgery.
2 secondary outcomes
Bleeding-related mortality
Time frame: 1 month
Complications to endoscopic therapy
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplementary endoscopy with doppler-guided therapy, IV. PPI and Endoscopic treatment at primary endoscopy in people with Peptic Ulcer Bleeding, run by Odense University Hospital at 2 sites in Denmark.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stig Laursen, MD PhD (+45 30207859, stig.laursen@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rebleeding (time frame: 1 week). 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 20 Apr 2017.