PolypsOPERANCT01481337
Endoscopic Mucosal Colonic Resection and Polypectomy Under Aspirin
An observational study of Polyps, run by Société Française d'Endoscopie Digestive at 1 site in France.
Trial summary
The endoscopic management of patients on anti platelet agents is a wide problem more and more common, with prevalence of patients on this type of therapy steadily increasing. The risk of bleeding on antiplatelet during an endoscopic examination can be major. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyps
- What is being tested?
- Colonic polypectomy or endoscopic mucosal resection (EMR)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 317 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2011to Oct 2012
- Phase
- Observational
- 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
Study population: Patient under chronic aspirin therapy (antiplatelet agent) for cardiovascular reason who underwent colonic polypectomy or endoscopic mucosal resection.
Who may be able to join
- Age ≥ 18 years, male or female
- Polypectomy AND / OR mucosectomy (EMR) performed on aspirin during a colonoscopy
- Taking a single daily dose of aspirin long-term (<375 mg for more than 3 months) in the prevention of cardiovascular and thromboembolic risk with a major or medium - secondary prevention
- Affiliation to the regime of national health protection
- Informed consent and patient's written obtained
- No participation in another clinical study
Who cannot join
- Contraindications to the achievement of a lower gastrointestinal endoscopy
- Taking a single daily dose of clopidogrel or other anti-platelet, anti vitamin K (AVK), heparin or anti bi aggregation in the context of cardiovascular prevention
- Taking chronic anti inflammatory drug (at least once weekly)
- Haemorrhagic disease, disorders of hemostasis and coagulation (PT <60%, aPTT> 40 sec. And platelets <60000/mm3), hematologic malignancy, chronic liver cirrhosis classified as Child Pugh B or C, acute or chronic renal failure
- Patient with severe disease and progressive decompensated in the opinion of the investigator
- Pregnant women, nursing
- Not signing the written consent and / or mental disabilities of the subject making its participation in the trial impossible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observatory of Endoscopic Mucosal Colonic Resection and Polypectomy Under Aspirin : the "OPERA" Study
The endoscopic management of patients on anti platelet agents is a wide problem more and more common, with prevalence of patients on this type of therapy steadily increasing. The risk of bleeding on antiplatelet during an endoscopic examination can be major. The risk of cardiovascular thrombotic accident in dirty shutdown of anti platelet, was recently described as significant (4-5%). Current recommendations for polypectomy allow the gesture as aspirin and are based on literature data scarce, often retrospective. Such work may be for a lack of increased bleeding risk during a colonic polypectomy under aspirin. There is to date no significant data published on the implementation of the endoscopic mucosal resection (mucosectomy) under aspirin. It is necessary to achieve a national multicenter observational study on a large scale in the daily practice of colonic polypectomy / mucosectomy in patient taking aspirin.
The aim of the study is to determine the incidence of immediate and delayed bleeding colonic polypectomy and mucosectomy with aspirin. The patients undergoing colonoscopy and taking a long-term aspirin therapy and presenting a major risk of thromboembolism or medium will incluables. Inclusion will be achieved for those patients receiving aspirin colonoscopy after signing a specific consent. Polypectomy will be possible according to the recommendations of the French Society of Digestive Endoscopy. Upon discovery of a lesion to be resected by mucosectomy, the patient will benefit from the mucosectomy. The study is observational, multicenter, prospective, national. The polypectomies / colonic mucosectomies will be made using the conventional techniques and the current recommendations. The immediate and delayed hemorrhage meet specific definitional criteria. The number of patients to be included will be 1000. The duration of the study inclusions will be 36 months. The trial will be conducted in full compliance with laws, regulations and ethical aspects.
It is expected in this work that the incidence of post-polypectomy bleeding under aspirin is the same. The rate of bleeding reported in the post mucosectomy size is higher compared to the polypectomy: it is however expected that the rate of bleeding in the post mucosectomy with or without aspirin is indifferent. It will follow a recommendation of French society adapted to endoscopy for this type of procedure
- Conditions
- Polyps
- Being tested
- Colonic polypectomy or endoscopic mucosal resection (EMR)
- Keywords
- colon, endoscopy, resection
- Medical subject headings
- Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonic polypectomy or endoscopic mucosal resection (EMR)Procedure or surgery
Resection of colonic polyps using polypectomy tehnique (with electrocoagulation) or mucosal resection (EMR or mucosectomy) with injection of physiological serum thus resection with electrocoagulation.
| Study group | Role | What they receive |
|---|---|---|
| Polypectomy or mucosal endoscopic resection under aspirin | Not described Receives: Procedure: Colonic polypectomy or endoscopic mucosal resection (EMR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delayed bleeding after polypectomy and / or colonic mucosectomy (endoscopic mucosal resection) in patients on aspirin
Measured: 30 days
Secondary outcomes (4)
Incidence of immediate bleeding after polypectomy and / or colonic mucosectomy in patients on aspirin
Measured: one minute
Efficacy of endoscopic hemostasis in case of bleeding induced
Measured: During the lenght of endoscopy (colonoscopy) and at 30 days
morbidity / mortality induced by immediate and delayed bleeding after polypectomy and / or colonic mucosectomy in patients on aspirin
Measured: 30 days
predictors of gastrointestinal bleeding post polypectomy / mucosectomy under aspirin by sub groups of patients obtained
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolypsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société Française d'Endoscopie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, VANBIERVLIET, Société Française d'Endoscopie Digestive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481337
- Sponsor's protocol ID
- OPERA
- Acronym
- OPERA
- Status last verified
- Apr 2014
- First submitted
- 21 Nov 2011
- Last updated
- 23 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observatory of Endoscopic Mucosal Colonic Resection and Polypectomy Under Aspirin : the "OPERA" Study
- ClinicalTrials.gov ID
- NCT01481337
- Acronym / sponsor ID
- OPERA / OPERA
- Conditions
- Polyps
- Keywords
- colon, endoscopy, resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Société Française d'Endoscopie DigestiveUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 29 Nov 2011 (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 endoscopic management of patients on anti platelet agents is a wide problem more and more common, with prevalence of patients on this type of therapy steadily increasing. The risk of bleeding on antiplatelet during an endoscopic examination can be major. The risk of cardiovascular thrombotic accident in dirty shutdown of anti platelet, was recently described as significant (4-5%). Current recommendations for polypectomy allow the gesture as aspirin and are based on literature data scarce, often retrospective. Such work may be for a lack of increased bleeding risk during a colonic polypectomy under aspirin. There is to date no significant data published on the implementation of the endoscopic mucosal resection (mucosectomy) under aspirin. It is necessary to achieve a national multicenter observational study on a large scale in the daily practice of colonic polypectomy / mucosectomy in patient taking aspirin.
The aim of the study is to determine the incidence of immediate and delayed bleeding colonic polypectomy and mucosectomy with aspirin. The patients undergoing colonoscopy and taking a long-term aspirin therapy and presenting a major risk of thromboembolism or medium will incluables. Inclusion will be achieved for those patients receiving aspirin colonoscopy after signing a specific consent. Polypectomy will be possible according to the recommendations of the French Society of Digestive Endoscopy. Upon discovery of a lesion to be resected by mucosectomy, the patient will benefit from the mucosectomy. The study is observational, multicenter, prospective, national. The polypectomies / colonic mucosectomies will be made using the conventional techniques and the current recommendations. The immediate and delayed hemorrhage meet specific definitional criteria. The number of patients to be included will be 1000. The duration of the study inclusions will be 36 months. The trial will be conducted in full compliance with laws, regulations and ethical aspects.
It is expected in this work that the incidence of post-polypectomy bleeding under aspirin is the same. The rate of bleeding reported in the post mucosectomy size is higher compared to the polypectomy: it is however expected that the rate of bleeding in the post mucosectomy with or without aspirin is indifferent. It will follow a recommendation of French society adapted to endoscopy for this type of procedure
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polypectomy or mucosal endoscopic resection under aspirin | – | Procedure: Colonic polypectomy or endoscopic mucosal resection (EMR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient under chronic aspirin therapy (antiplatelet agent) for cardiovascular reason who underwent colonic polypectomy or endoscopic mucosal resection.
Key inclusion criteria (6 listed)
- Age ≥ 18 years, male or female
- Polypectomy AND / OR mucosectomy (EMR) performed on aspirin during a colonoscopy
- Taking a single daily dose of aspirin long-term (<375 mg for more than 3 months) in the prevention of cardiovascular and thromboembolic risk with a major or medium - secondary prevention
- Affiliation to the regime of national health protection
- Informed consent and patient's written obtained
Key exclusion criteria (7 listed)
- Contraindications to the achievement of a lower gastrointestinal endoscopy
- Taking a single daily dose of clopidogrel or other anti-platelet, anti vitamin K (AVK), heparin or anti bi aggregation in the context of cardiovascular prevention
- Taking chronic anti inflammatory drug (at least once weekly)
- Haemorrhagic disease, disorders of hemostasis and coagulation (PT <60%, aPTT> 40 sec. And platelets <60000/mm3), hematologic malignancy, chronic liver cirrhosis classified as Child Pugh B or C, acute or chronic renal failure
- Patient with severe disease and progressive decompensated in the opinion of the investigator
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 |
|---|---|---|
| Colonic polypectomy or endoscopic mucosal resection (EMR)Resection of colonic polyps using polypectomy tehnique (with electrocoagulation) or mucosal resection (EMR or mucosectomy) with injection of physiological serum thus resection with electrocoagulation. | Procedure or surgery | Polypectomy or mucosal endoscopic resection under aspirin |
Primary outcome
Incidence of delayed bleeding after polypectomy and / or colonic mucosectomy (endoscopic mucosal resection) in patients on aspirin
Time frame: 30 days
4 secondary outcomes
Incidence of immediate bleeding after polypectomy and / or colonic mucosectomy in patients on aspirin
Time frame: one minute
Efficacy of endoscopic hemostasis in case of bleeding induced
Time frame: During the lenght of endoscopy (colonoscopy) and at 30 days
morbidity / mortality induced by immediate and delayed bleeding after polypectomy and / or colonic mucosectomy in patients on aspirin
Time frame: 30 days
predictors of gastrointestinal bleeding post polypectomy / mucosectomy under aspirin by sub groups of patients obtained
Time frame: 30 days
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 23 Apr 2014.
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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?
An observational study of Polyps, run by Société Française d'Endoscopie Digestive at 1 site in France.
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 7 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 23 Apr 2014. 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 France. 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?
Incidence of delayed bleeding after polypectomy and / or colonic mucosectomy (endoscopic mucosal resection) in patients on aspirin (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 Apr 2014.