Antihemostatic Therapy and Endoscopic Biliary Sphincterot... | NCT01098617

Studies
Antihemostatic Therapy and Endoscopic Biliary Sphincterotomy Induced Bleeding

NCT01098617

Sponsor

Yuksek Ihtisas Hospital

Status

Unknown status

Last Update Posted

Apr 5, 2010Estimated

Enrollment

350Estimated

Phase

Not provided

Conditions

Endoscopic Biliary Sphincterotomy
Bleeding

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Nov 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Apr 1, 2010

First Submission Date that Met QC Criteria

Apr 2, 2010

First Posted Date

Apr 5, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2010

Last Update Posted Date

Apr 5, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

350Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hemorrhage		The patients who had bleeding induced by endoscopic sphincterotomy

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bleeding induced by endoscopic biliary sphincterotomy		3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The patients who had undergone endoscopic sphincterotomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ibrahim Koral Onal, MD	Contact	903123061334		koralonal@yahoo.com

Overall Officials

Name	Affiliation	Role
Meral Akdoğan, MD	Turkiye Yuksek Ihtisas Hospital Gastroenterology Department	Principal Investigator
Ibrahim Koral Onal, MD	Turkiye Yuksek Ihtisas Hospital Gastroenterology Department	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Turkiye Yuksek Ihtisas Hospital	Recruiting	Ankara			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D006470	Hemorrhage

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided