Recto Colonic Endoscopic Mucosal Resection and Polypectomy Under Clopidogrel (MEDOC)

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.

Study Overview

• Status: Completed
• Conditions: Polyps
• Intervention / Treatment: Procedure: Colonic polypectomy or endoscopic mucosal resection (EMR).

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33400
    • Centre hospitalier Universitaire de Bordeaux
  • Brest, France, 29609
    • Centre Hospitalier Universitaire de Brest
  • Nice, France, 06003
    • Centre Hospitalier Universitaire de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 18 years, male or female
• Polypectomy AND / OR mucosectomy (EMR) performed on clopidogrel and/or aspirin during a colonoscopy with inability to defer action
• Taking a single daily dose of clopidogrel long-term (more than 3 months) or under treatment with clopidogrel and aspirin (aspirin < 375 mg 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

Exclusion Criteria:

• 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)
• Resection technique submucosal dissection
• Haemorrhagic disease, disorders of hemostasis and coagulation (PT <60%, aPTT> 40 sec. And platelets <100000/mm3), hematologic malignancy, chronic liver cirrhosis classified as Child Pugh B or C, acute or chronic renal failure
• Acute Coronary Syndrome <3 months or not received percutaneous coronary intervention (PCI).
• Angioplasty with placement of a stent drug evaluation (out of context of acute coronary syndrome) <3 months.
• Angioplasty with placement of a bare metal stent (out of context of acute coronary syndrome) <4 weeks.
• Pregnant women, nursing
• Not signing the written consent and / or mental disabilities of the subject making its participation in the trial impossible

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colonic polypectomy or endoscopic mucosal resection; 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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of delayed bleeding after polypectomy and / or colonic mucosectomy	Incidence of delayed bleeding after polypectomy and / or colonic mucosectomy (endoscopic mucosal resection) in patients on clopidogrel	during surgery, hospitalization and at 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of immediate bleeding after polypectomy and / or colonic mucosectomy		during surgery, hospitalization and at 30 days
Incidence of severe bleeding after polypectomy and / or colonic mucosectomy in patients on Clopidogrel		during surgery, hospitalization and at 30 days
Efficacy of endoscopic hemostasis in case of bleeding induced	Defined by the cessation of bleeding without the need for further treatment (surgery, radiation)	in case of bleeding induced
morbidity / mortality induced by immediate and delayed bleeding after polypectomy and / or colonic mucosectomy in patients on clopidogrel		during surgery, hospitalization and at 30 days
predictors of gastrointestinal bleeding post polypectomy / mucosectomy under clopidogrel by sub groups of patients obtained		during surgery, hospitalization and at 30 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Study Director: Geoffroy VANBIERVLIET, MD, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2013
• Primary Completion (Actual): November 7, 2017
• Study Completion (Actual): November 7, 2017

Study Registration Dates

• First Submitted: March 4, 2013
• First Submitted That Met QC Criteria: March 6, 2013
• First Posted (Estimate): March 8, 2013

Study Record Updates

• Last Update Posted (Actual): August 6, 2018
• Last Update Submitted That Met QC Criteria: August 3, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: endoscopy; clopidogrel; colon; resection
• Other Study ID Numbers: 12-AOI-05; 2012-005365-12 (EudraCT Number)