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Postpolypectomy Bleeding in Patients With Antiplatelet Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Hyun Gun, Kim. M.D., Ph.D., Soonchunhyang University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bleeding Complication During Colon Polypectomy Drug: Aspirin Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Aspirin

Arm Intervention/treatment
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.
Drug: Aspirin
Aspirin hold for a certain period of time in the patients who take aspirin for the primary prevention of vascular disease,

Primary Outcome Measures :
  1. postpolypectomy bleeding rate [ Time Frame: bleeding after polypectomy within 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • The patients who take low dose aspirin (75~160mg) for primary prevention of vascular disease and low risk for thromboembolism.

Exclusion Criteria:

  • The patients who taking anti-thrombotic agents,
  • The patients who taking thienopyridines or other NSAID with aspirin,
  • The patients who have low platelet count(<80,000/mm3) and prolongated PT/aPTT in laboratory test,
  • The patients who have chronic renal disease (creatinine>3mg/dl over 6 months),
  • The patients who have polyps over than 1 cm in size or thick pedicle over 1 cm,
  • The patients who have GI malignancies,the patients who are over ASA classification class III.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01465256

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Korea, Republic of
Soonchunhyang univerisity hospital Recruiting
Seoul, Korea, Republic of, 140-743
Contact: Hyun Gun Kim, MD., PhD.   
Principal Investigator: Hyun Gun Kim, MD., PhD.         
Sponsors and Collaborators
Soonchunhyang University Hospital
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Responsible Party: Hyun Gun, Kim. M.D., Ph.D., Assistant professor, Soonchunhyang University Hospital Identifier: NCT01465256    
Other Study ID Numbers: KASIDPOLYP
First Posted: November 4, 2011    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014
Keywords provided by Hyun Gun, Kim. M.D., Ph.D., Soonchunhyang University Hospital:
Colon polypectomy
Additional relevant MeSH terms:
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Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors