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NCT01098617 Clinical Trial

Antihemostatic Therapy and Endoscopic Biliary Sphincterotomy Induced Bleeding

Bleeding Clinical Trial

Official title:
The Effect of Antiaggregant, Anticoagulant and Nonsteroidal Antiinflammatory Therapy on Endoscopic Biliary Sphincterotomy Induced Bleeding

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01098617
Other study ID # PMS207
Secondary ID
Status Recruiting
Phase N/A
First received April 1, 2010
Last updated April 2, 2010
Start date April 2010
Est. completion date December 2010

Study information
Verified date April 2010
Source Yuksek Ihtisas Hospital
Contact Ibrahim Koral Onal, MD
Phone 903123061334
Email koralonal@yahoo.com
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Observational

Clinical Trial Summary

The aim of the study is to observe the effects of antihemostatic therapy including nonsteroidal antiinflammatory, anticoagulant and antiaggregant therapy and other patient and procedure related factors on the risk of endoscopic biliary sphincterotomy induced bleeding.

Recruitment information / eligibility
Status Recruiting
Enrollment 350
Est. completion date December 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 17 Years and older
Eligibility Inclusion Criteria:

- Hospitalization

- Endoscopic sphincterotomy

- The patients whose warfarin treatment was stopped and INR was normalized prior to examination

Exclusion Criteria:

- The patients who had undergone endoscopic cholangiography with no sphincterotomy

- Outpatient procedures

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey Turkiye Yuksek Ihtisas Hospital Ankara

Sponsors (1)
Lead Sponsor Collaborator
Yuksek Ihtisas Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bleeding induced by endoscopic biliary sphincterotomy 3 months Yes
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