Postpolypectomy Bleeding in Patients With Antiplatelet Therapy
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|ClinicalTrials.gov Identifier: NCT01465256|
Recruitment Status : Unknown
Verified March 2014 by Hyun Gun, Kim. M.D., Ph.D., Soonchunhyang University Hospital.
Recruitment status was: Recruiting
First Posted : November 4, 2011
Last Update Posted : March 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Bleeding Complication During Colon Polypectomy||Drug: Aspirin||Not Applicable|
Based on very limited evidences, ASGE recommended that endoscopic procedures may be performed on patients taking aspirin. However in a survey of ASGE members regarding their endoscopic practice, 81% would consider discontinuation of aspirin before colonoscopy and 66% would not perform snare polypectomy if patients had not discontinued aspirin. Although a large prospective randomized control trial would be the ideal way to address this issue theoretically, the investigators hypothesized that there are no differences of the post polypectomy bleeding rate in patients whether continuous taking aspirin prior to polypectomy or not.
In this study, we classified the patients into two groups; the patients who can stop taking aspirin before colon polypectomy will be enrolled into group 1, and the patients who take both thienopyridines and aspirin for their underlying disease and should keep take aspirin during colon polypectomy will be enrolled into group 2. The patients of group 1 stop taking aspirin 7 days before polypectomy.
thromboembolism. Exclusions are as follow; patients taking anti-thrombotic agents, patients have low a platelet count (<80,000/mm3) and/or prolongated PT/aPTT, patients who have chronic renal disease (creatinine>3mg/dl over 6 months), patients who have GI malignancies, patients who are over ASA classification class III, over 2 score of HAS-BLED and over 1 of CHAD2 score. The expected enrolled patients number is 500 patients (250 in each group).
All cases of polypectomy are performed with identical methodology; resection after epinephrine mixture injection under blended or mixed current wave. The data includes the patients information such as sex, age, body weight, BMI and vascular disease history such as hypertension, diabetes, ischemic heart disease, cerebrovascular disease, COPD, modified HAS-BLED score and CHADS2 score. The data of polyp related factor include number of polyps, bleeding status(acute, early, delayed/minimal, moderate, sever), endoscopist (staff or fellow), bowel preparation status, polyp character (shape, location, pathology) and procedures for bleeding (clipping, APC, epinephrine injection, band ligation etc.).
All procedure will be performed with the endoscopist blinded to the patient status of whether the patient is taking aspirin continuously or not.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Postpolypectomy Bleeding in Patients Undergoing Colonoscopy on Antiplatelet Therapy. - Multicenter, Prospective Observational Study -|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||June 2014|
No Intervention: Aspirin holding group
Aspirin holding group (group 1): the patients enrolled into group 1 can stop taking aspirin during colon polypectomy. The patients are usually taking aspirin for primary prevention of vascular disease and have no risk of thromboembolism despite of they stop taking aspirin temporary
Experimental: Aspirin continuing group
Aspirin continuing group (group 2): the patients enrolled into group 2 should take aspirin during colon polypectomy because these patients are usually take thienopyridines and aspirin, and if they would stop taking aspirin during colon polypectomy, they have a thromboembolism risk.
Aspirin hold for a certain period of time in the patients who take aspirin for the primary prevention of vascular disease,
- postpolypectomy bleeding rate [ Time Frame: bleeding after polypectomy within 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01465256
|Korea, Republic of|
|Soonchunhyang univerisity hospital||Recruiting|
|Seoul, Korea, Republic of, 140-743|
|Contact: Hyun Gun Kim, MD., PhD. email@example.com|
|Principal Investigator: Hyun Gun Kim, MD., PhD.|