Recto Colonic Endoscopic Mucosal Resection and Polypectomy Under Clopidogrel

NCT01807169 | Completed Phase 4 DMC

• 2 other identifiers: 12-AOI-052012-005365-12
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Polyps

Keywords

colon; endoscopy; resection; clopidogrel

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  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

Study Arms (1)

Colonic polypectomy or endoscopic mucosal resection

EXPERIMENTAL

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).

Interventions

Colonic polypectomy or endoscopic mucosal resection (EMR). PROCEDURE

Resection of colonic polyps using polypectomy tehnique (with electrocoagulation) or mucosal resection (EMR or mucosectomy) with injection of physiological serum thus resection with electrocoagulation

Colonic polypectomy or endoscopic mucosal resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (3)

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33400, France

Location

Centre Hospitalier Universitaire de Brest

Brest, 29609, France

Location

Centre Hospitalier Universitaire de Nice

Nice, 06003, France

Location

MeSH Terms

Conditions

Polyps

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Geoffroy VANBIERVLIET, MD

  Centre Hospitalier Universitaire de Nice

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2013
• First Posted: March 8, 2013
• Study Start: May 14, 2013
• Primary Completion: November 7, 2017
• Study Completion: November 7, 2017
• Last Updated: August 6, 2018

Record last verified: 2018-08

Locations

FR (3)