Antihemostatic Therapy and Endoscopic Biliary Sphincterotomy Induced Bleeding

April 2, 2010 updated by: Yuksek Ihtisas Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Turkiye Yuksek Ihtisas Hospital
        • Principal Investigator:
          • Ibrahim Koral Onal, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients who had undergone endoscopic sphincterotomy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
hemorrhage
The patients who had bleeding induced by endoscopic sphincterotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bleeding induced by endoscopic biliary sphincterotomy
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuksek Ihtisas Hospital

Investigators

  • Principal Investigator: Meral Akdoğan, MD, Turkiye Yuksek Ihtisas Hospital Gastroenterology Department
  • Principal Investigator: Ibrahim Koral Onal, MD, Turkiye Yuksek Ihtisas Hospital Gastroenterology Department
  • Study Director: Erkan Parlak, MD, Turkiye Yuksek Ihtisas Hospital Gastroenterology Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

November 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

April 1, 2010

First Submitted That Met QC Criteria

April 2, 2010

First Posted (Estimate)

April 5, 2010

Study Record Updates

Last Update Posted (Estimate)

April 5, 2010

Last Update Submitted That Met QC Criteria

April 2, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMS207

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bleeding

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe