Peptic Ulcer HemorrhageNCT01125852
Supplementary Angiographic Embolization for Peptic Ulcer Bleeding
A study testing Angiographic embolization and Therapeutic endoscopy in people with Peptic Ulcer Hemorrhage, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Peptic ulcer bleeding is a common disorder. Despite optimal endoscopic and medical treatment, there is a high risk of rebleeding and high mortality. In this study the investigators examine whether combined endoscopic haemostasis and angiographic embolization resolves in a better outcome than the traditional use of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peptic Ulcer Hemorrhage
- What is being tested?
- Angiographic embolization and Therapeutic endoscopy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2009to May 2012
- 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
- Clinical signs of upper GI-bleeding
- Endoscopic verified high-risk ulcer (Forrest I-IIb)
- Primary haemostasis achieved
Who cannot join
- Expected lifetime < 1 month
- Upper GI-cancer found at endoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supplementary Angiographic Embolization for Peptic Ulcer Bleeding: A Randomized Controlled Trial
Peptic ulcer bleeding is a common disorder. Despite optimal endoscopic and medical treatment, there is a high risk of rebleeding and high mortality. In this study the investigators examine whether combined endoscopic haemostasis and angiographic embolization resolves in a better outcome than the traditional use of endoscopic haemostasis alone. The study is a randomised controlled trail.
- Conditions
- Peptic Ulcer Hemorrhage
- Being tested
- Angiographic embolization, Therapeutic endoscopy
- Keywords
- Peptic ulcer hemorrhage, Peptic ulcer bleeding, Angiographic embolization, Arterial embolization, Angiography
- 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.
Angiographic embolizationProcedure or surgery
Also called Therapeutic angiography, Arterial embolization, Transcatheter arterial embolization, Embolization
Patients in the intervention arm receive supplementary angiographic embolization within 24 hours from the therapeutic endoscopy.
Therapeutic endoscopyProcedure or surgery
Patients are treated with standard therapeutic upper endoscopy including endoscopic combination therapy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Patients in this group are treated with usual therapeutic endoscopy including endoscopic combination therapy and 72 hours intravenous proton pump inhibitor. Within 24 hours from the therapeutic endoscopy they receive supplementary angiographic embolization. Receives: Procedure: Angiographic embolization |
| Control group | Active comparator | Patients in this arm receive standard treatment including therapeutic endoscopy with endoscopic combination therapy followed by 72 hours intravenous proton pump inhibitor. Receives: Procedure: Therapeutic endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Endpoint
Patients are classified into groups depending on the worst outcome:
- No clinical signs of rebleeding and requirement of two or less blood transfusions after circulatory stabilization and obtained hemoglobin > 5,9mmol/L.
- No clinical signs of rebleeding and requirement of more than two blood transfusions after circulatory stabilization and obtained hemoglobin > 5,9mmol/L.
- Rebleeding and achieved secondary haemostasis by endoscopy or angiographic embolization.
- Rebleeding requiring surgery.
- Patients who have died.
Results are compared using the Wilcoxon rank sum test.
Measured: Meassured after a week from primary therapeutic endoscopy
Secondary outcomes (7)
Mortality
Patients who have died within af month from therapeutic endoscopy.
Measured: 1 month
Rebleeding
Rebleeding from ulcer confirmed by endoscopy, angiography or surgery within a month from therapeutic endoscopy.
Measured: 1 month
Blood transfusion
Amount of received blood transfusions after circulatory stabilization and obtained hemoglobin > 5,9mmol/L. Patients will only receive blood transfusion if hemoglobin < 6,0mmol/L
Measured: 1 month
Surgical haemostasis
Rebleeding requiring surgical haemostasis within a month from therapeutic endoscopy.
Measured: 1 month
Endoscopic/other haemostatic retreatment
Rebleeding confirmed by endoscopy or angiography and achieved secondary haemostasis by endoscopy or angiographic embolization.
Measured: 1 month
Duration of hospitalization
Time from hospitalization to discharge.
Measured: Estimated 4 days
Thromboembolic complications
Occurence of thromboembolic complications due to angiographic embolization, surgery or therapeutic endoscopy.
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 posted19 May 2010 (estimated)
- Study startSep 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peptic Ulcer HemorrhageStudies of the same condition, open and under way.
- 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
- 105 participants (actual)
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
- NCT01125852
- Sponsor's protocol ID
- S-20090086
- Status last verified
- May 2013
- First submitted
- 10 May 2010
- Last updated
- 14 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Laursen SB, Hansen JM, Andersen PE, Schaffalitzky de Muckadell OB. Supplementary arteriel embolization an option in high-risk ulcer bleeding--a randomized study. Scand J Gastroenterol. 2014 Jan;49(1):75-83. doi: 10.3109/00365521.2013.854829. Epub 2013 Nov 21.
PubMed 24256098
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementary Angiographic Embolization for Peptic Ulcer Bleeding: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01125852
- Acronym / sponsor ID
- S-20090086
- Conditions
- Peptic Ulcer Hemorrhage
- Keywords
- Peptic ulcer hemorrhage, Peptic ulcer bleeding, Angiographic embolization, Arterial embolization, Angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 19 May 2010 (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.
Peptic ulcer bleeding is a common disorder. Despite optimal endoscopic and medical treatment, there is a high risk of rebleeding and high mortality. In this study the investigators examine whether combined endoscopic haemostasis and angiographic embolization resolves in a better outcome than the traditional use of endoscopic haemostasis alone. The study is a randomised controlled trail.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Procedure: Angiographic embolizationPatients in this group are treated with usual therapeutic endoscopy including endoscopic combination therapy and 72 hours intravenous proton pump inhibitor. Within 24 hours from the therapeutic endoscopy they receive supplementary angiographic embolization. |
| Control group | Active comparator | Procedure: Therapeutic endoscopyPatients in this arm receive standard treatment including therapeutic endoscopy with endoscopic combination therapy followed by 72 hours intravenous proton pump inhibitor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical signs of upper GI-bleeding
- Endoscopic verified high-risk ulcer (Forrest I-IIb)
- Primary haemostasis achieved
Key exclusion criteria (2 listed)
- Expected lifetime < 1 month
- Upper GI-cancer found at endoscopy
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 |
|---|---|---|
| Angiographic embolizationAlso: Therapeutic angiography, Arterial embolization, Transcatheter arterial embolization, EmbolizationPatients in the intervention arm receive supplementary angiographic embolization within 24 hours from the therapeutic endoscopy. | Procedure or surgery | Intervention group |
| Therapeutic endoscopyPatients are treated with standard therapeutic upper endoscopy including endoscopic combination therapy. | Procedure or surgery | Control group |
Primary outcome
Composite Endpoint
Time frame: Meassured after a week from primary therapeutic endoscopy
Patients are classified into groups depending on the worst outcome: 1. No clinical signs of rebleeding and requirement of two or less blood transfusions after circulatory stabilization and obtained hemoglobin > 5,9mmol/L. 2. No clinical signs of rebleeding and requirement of more than two blood transfusions after circulatory stabilization and obtained hemoglobin > 5,9mmol/L. 3. Rebleeding and achieved secondary haemostasis by endoscopy or angiographic embolization. 4. Rebleeding requiring surgery. 5. Patients who have died. Results are compared using the Wilcoxon rank sum test.
7 secondary outcomes
Mortality
Time frame: 1 month
Rebleeding
Time frame: 1 month
Blood transfusion
Time frame: 1 month
Surgical haemostasis
Time frame: 1 month
Endoscopic/other haemostatic retreatment
Time frame: 1 month
Duration of hospitalization
Time frame: Estimated 4 days
Thromboembolic complications
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2013.
- Derived from this study: PubMed 24256098Laursen SB, Hansen JM, Andersen PE, Schaffalitzky de Muckadell OB. Supplementary arteriel embolization an option in high-risk ulcer bleeding--a randomized study. Scand J Gastroenterol. 2014 Jan;49(1):75-83. doi: 10.3109/00365521.2013.854829. Epub 2013 Nov 21.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angiographic embolization and Therapeutic endoscopy in people with Peptic Ulcer Hemorrhage, run by Odense University Hospital at 1 site 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 14 May 2013. 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 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite Endpoint (time frame: Meassured after a week from primary therapeutic endoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01125852, which also lists 1 linked publication.
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 14 May 2013.