Polyps Clinical Trial
Official title:
Recto Colonic Endoscopic Mucosal Resection and Polypectomy Under Clopidogrel: the "MEDOC"Study.
The endoscopic management of patients on anti platelet agents (APA) is a wide problem, with
prevalence of patients on this type of therapy steadily increasing. The benefit / risk
balance to stop or continue the APA for the digestive endoscopic procedure confronts us every
day in clinical practice to another: the relationship thrombosis / hemorrhage.
Molecules most commonly used today are aspirin and clopidogrel. Current recommendations from
the European Society of Gastrointestinal Endoscopy (ESGE) allow the maintenance of aspirin
for the polypectomy. Some preliminary data show that the risk of bleeding during endoscopic
mucosal resection (EMR) with aspirin is not significantly higher than polypectomy. The
concept of polypectomy / EMR without stopping aspirin is progressively accepted and returned
gradually to the usual practice. However, these procedures are still not allowed under
clopidogrel, or in a dual APA therapy, in the absence of relevant data on the subject in the
literature.
It is necessary to achieve a large national multicenter study, to clarify the risk of post
recto colonic EMR and polypectomy bleeding in patients under clopidogrel alone or in
combination (aspirin and clopidogrel) taking into account the endoscopic preventive measures
used in daily practice by endoscopists in expert centers (clip, ligature and loop devices,
preventive adrenalin injection).
The aim of the "MEDOC" study is to determine the incidence of immediate and delayed bleeding
after colonic polypectomy and / or EMR for patients on clopidogrel.
It is expected in this work an incidence of post-polypectomy bleeding close to that observed
during the implementation of these actions in the population without any anti platelet
agents.
The endoscopic management of patients on anti platelet agents (APA) is a wide problem, due to
the dramatically increasing prevalence of patients on these therapies. The benefit / risk
balance to stop or continue the APA for the digestive endoscopic procedure confronts us every
day in clinical practice to another: the relationship thrombosis / hemorrhage. The
maintenance of an APA is particularly essential for acute coronary episode, but in the long
term, in prevention of recurrent thrombotic cardiovascular disease. Molecules most commonly
used today are aspirin and clopidogrel.
Current recommendations from the European Society of Gastrointestinal Endoscopy (ESGE) allow
the maintenance of aspirin for the polypectomy. Some preliminary data show that the risk of
bleeding during endoscopic mucosal resection (EMR) with aspirin is not significantly higher
than polypectomy. The concept of polypectomy / EMR without stopping aspirin is progressively
accepted and returned gradually to the usual practice. However, these procedures are still
not allowed under clopidogrel, or in a dual APA therapy, in the absence of relevant data on
the subject in the literature.
However recent studies disrupt this problem for different reasons: i) endoscopic haemostatic
preventive measures have demonstrated efficacy in reducing the rate of immediate and delayed
bleeding post polypectomy or EMR; ii) the inadequate modification or untimely stopping APA
treatment is always complicated by severe vascular thrombosis events in 5% of patients; iii)
three retrospective studies relativize the risk of bleeding after a colonic polypectomy under
clopidogrel. It is therefore essential to carry out a prospective, large-scale, multicenter,
study to clarify the risk of post colonic EMR/polypectomy bleeding in patients under
clopidogrel alone or in combination (aspirin and clopidogrel) taking into account the
endoscopic preventive measures used in daily practice by endoscopists in expert centers
(clip, ligature and loop devices, preventive adrenalin injection).
The aim of the "MEDOC" study is to determine the incidence of immediate and delayed bleeding
after colonic polypectomy and / or EMR for patients on clopidogrel.
The study presents an interventional prospective multicentric and national design.
300 patients will be included. The duration of the study inclusions will be 18 months.
It is expected in this work an incidence of post-polypectomy bleeding close to that observed
during the implementation of these actions in the population without any anti platelet
agents.
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