NCT01098617

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 5, 2010

Status Verified

April 1, 2010

Enrollment Period

7 months

First QC Date

April 1, 2010

Last Update Submit

April 2, 2010

Conditions

Endoscopic Biliary SphincterotomyBleeding

Keywords

endoscopic sphincterotomyhemorrhagenonsteroidal antiinflammatory agentsantiaggregantsanticoagulantsEndoscopic biliary sphincterotomy induced bleeding

Outcome Measures

Primary Outcomes (1)

  • Bleeding induced by endoscopic biliary sphincterotomy

    3 months

Study Arms (1)

hemorrhage

The patients who had bleeding induced by endoscopic sphincterotomy

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients who had undergone endoscopic sphincterotomy

You may qualify if:

  • Hospitalization
  • Endoscopic sphincterotomy
  • The patients whose warfarin treatment was stopped and INR was normalized prior to examination

You may not qualify if:

  • The patients who had undergone endoscopic cholangiography with no sphincterotomy
  • Outpatient procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turkiye Yuksek Ihtisas Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Meral Akdoğan, MD

    Turkiye Yuksek Ihtisas Hospital Gastroenterology Department

    PRINCIPAL INVESTIGATOR

  • Ibrahim Koral Onal, MD

    Turkiye Yuksek Ihtisas Hospital Gastroenterology Department

    PRINCIPAL INVESTIGATOR

  • Erkan Parlak, MD

    Turkiye Yuksek Ihtisas Hospital Gastroenterology Department

    STUDY DIRECTOR

Central Study Contacts

Ibrahim Koral Onal, MD

CONTACT

903123061334koralonal@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 1, 2010

First Posted

April 5, 2010

Study Start

April 1, 2010

Primary Completion

November 1, 2010

Study Completion

December 1, 2010

Last Updated

April 5, 2010

Record last verified: 2010-04

Locations

TU(1)