Periampullary NeoplasmsNCT00880633
Endoscopic Ultrasound Staging of Periampullary Neoplasms: Retrospective
An observational study of Periampullary Neoplasms, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this retrospective study is to determine the degree to which a biliary stent affects EUS staging accuracy of ampullary tumors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Periampullary Neoplasms
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Feb 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Retrospective review of patients who have already undergone an EUS at this institution.
Who may be able to join
- Patients will be identified retrospectively through an existing Indiana University Medical Center EUS database and pathology database.
- Patients with and without biliary stents will be included.
Who cannot join
- Patients that were suspected to have ampullary tumors but who were ultimately found to have a normal ampulla will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Hospital
Indianapolis, Indiana, 46202
About this study
Official title: EUS Staging Accuracy of Periampullary Neoplasms: a Retrospective Review
The purpose of this retrospective study is to determine the degree to which a biliary stent affects EUS staging accuracy of ampullary tumors.
- Conditions
- Periampullary Neoplasms
- Keywords
- EUS, periampullary neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of a biliary stent decreases EUS staging accuracy due to the intervening shadow artifacts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2009 (estimated)
- Study startApr 2007
- Primary completionJan 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periampullary NeoplasmsStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880633
- Sponsor's protocol ID
- 0703-58
- Status last verified
- Feb 2011
- First submitted
- 13 Apr 2009
- Last updated
- 17 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS Staging Accuracy of Periampullary Neoplasms: a Retrospective Review
- ClinicalTrials.gov ID
- NCT00880633
- Acronym / sponsor ID
- 0703-58
- Conditions
- Periampullary Neoplasms
- Keywords
- EUS, periampullary neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 14 Apr 2009 (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 purpose of this retrospective study is to determine the degree to which a biliary stent affects EUS staging accuracy of ampullary tumors.
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Retrospective review of patients who have already undergone an EUS at this institution.
Key inclusion criteria (2 listed)
- Patients will be identified retrospectively through an existing Indiana University Medical Center EUS database and pathology database.
- Patients with and without biliary stents will be included.
Key exclusion criteria (1 listed)
- Patients that were suspected to have ampullary tumors but who were ultimately found to have a normal ampulla will be excluded.
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
The presence of a biliary stent decreases EUS staging accuracy due to the intervening shadow artifacts
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Periampullary Neoplasms, run by Indiana University at 1 site in United States.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 17 Feb 2011. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The presence of a biliary stent decreases EUS staging accuracy due to the intervening shadow artifacts. 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 17 Feb 2011.