Endoscopic Biliary SphincterotomyNCT01098617
Antihemostatic Therapy and Endoscopic Biliary Sphincterotomy Induced Bleeding
An observational study of Endoscopic Biliary Sphincterotomy and Bleeding, run by Yuksek Ihtisas Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Endoscopic Biliary Sphincterotomy, Bleeding
- How many people
- 350 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2010to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients who had undergone endoscopic sphincterotomy
Who may be able to join
- Hospitalization
- Endoscopic sphincterotomy
- The patients whose warfarin treatment was stopped and INR was normalized prior to examination
Who cannot join
- The patients who had undergone endoscopic cholangiography with no sphincterotomy
- Outpatient procedures
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Turkiye Yuksek Ihtisas Hospital
Ankara
Ibrahim Koral Onal, MD
About this study
Official title: 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.
- Conditions
- Endoscopic Biliary Sphincterotomy, Bleeding
- Keywords
- endoscopic sphincterotomy, hemorrhage, nonsteroidal antiinflammatory agents, antiaggregants, anticoagulants, Endoscopic biliary sphincterotomy induced bleeding
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hemorrhage | The patients who had bleeding induced by endoscopic sphincterotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding induced by endoscopic biliary sphincterotomy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionNov 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Biliary SphincterotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuksek Ihtisas Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Meral Akdoğan, MD, Principal investigator, Turkiye Yuksek Ihtisas Hospital Gastroenterology DepartmentIbrahim Koral Onal, MD, Principal investigator, Turkiye Yuksek Ihtisas Hospital Gastroenterology DepartmentErkan Parlak, MD, Study director, Turkiye Yuksek Ihtisas Hospital Gastroenterology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098617
- Sponsor's protocol ID
- PMS207
- Status last verified
- Apr 2010
- First submitted
- 1 Apr 2010
- Last updated
- 5 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Antiaggregant, Anticoagulant and Nonsteroidal Antiinflammatory Therapy on Endoscopic Biliary Sphincterotomy Induced Bleeding
- ClinicalTrials.gov ID
- NCT01098617
- Acronym / sponsor ID
- PMS207
- Conditions
- Endoscopic Biliary Sphincterotomy, Bleeding
- Keywords
- endoscopic sphincterotomy, hemorrhage, nonsteroidal antiinflammatory agents, antiaggregants, anticoagulants, Endoscopic biliary sphincterotomy induced bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Yuksek Ihtisas HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 5 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hemorrhage | – | –The patients who had bleeding induced by endoscopic sphincterotomy |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients who had undergone endoscopic sphincterotomy
Key inclusion criteria (3 listed)
- Hospitalization
- Endoscopic sphincterotomy
- The patients whose warfarin treatment was stopped and INR was normalized prior to examination
Key exclusion criteria (2 listed)
- The patients who had undergone endoscopic cholangiography with no sphincterotomy
- Outpatient procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bleeding induced by endoscopic biliary sphincterotomy
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meral Akdoğan, MD principal investigator
Turkiye Yuksek Ihtisas Hospital Gastroenterology Department
Ibrahim Koral Onal, MD principal investigator
Turkiye Yuksek Ihtisas Hospital Gastroenterology Department
Erkan Parlak, MD study director
Turkiye Yuksek Ihtisas Hospital Gastroenterology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopic Biliary Sphincterotomy and Bleeding, run by Yuksek Ihtisas Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ibrahim Koral Onal, MD (903123061334, koralonal@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding induced by endoscopic biliary sphincterotomy (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2010; AzTrials last refreshed its copy on 1 Nov 2026.