Bleeding Complication During Colon Polypectomy Clinical Trial
Official title:
Postpolypectomy Bleeding in Patients Undergoing Colonoscopy on Antiplatelet Therapy. - Multicenter, Prospective Observational Study -
The purpose of this study is to determine if the use of aspirin prior to colonoscopy increases the risk of post polypectomy bleeding. The primary end point is comparison of bleeding rates after polypectomy of a continuous aspirin group and temporally aspirin-quit group. The secondary end point is analysis of risk factors which affect early or delayed post polypectomy bleeding.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator)