Recto Colonic Endoscopic Mucosal Resection and Polypectomy Under Clopidogrel — MEDOC  

Polyps Clinical Trial

Official title: Recto Colonic Endoscopic Mucosal Resection and Polypectomy Under Clopidogrel: the "MEDOC"Study.

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Polyps

• NCT number: NCT01807169
• Study type: Interventional
• Source: Centre Hospitalier Universitaire de Nice
• Status: Completed
• Phase: Phase 4
• Start date: May 14, 2013
• Completion date: November 7, 2017