Chronic PancreatitisNCT01442441
Correlation of Chronic Pancreatitis Pathology Features With Endoscopic Ultrasound (EUS) Criteria
An observational study of Chronic Pancreatitis, run by Indiana University at 1 site in United States.
Trial summary
In this research project the investigators intend to find out if Endoscopic Ultrasound (EUS) criteria for diagnosing chronic pancreatitis can be correlated with pathologic characteristics of tissues taken from pancreas of patients with suspected chronic pancreatitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pancreatitis
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Sep 2013
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Retrospective surgery cases who had chronic pancreatitis
Who may be able to join
- will include all patients who consented to have both EUS and had biopsy taken for tissue diagnosis.
Who cannot join
- Will exclude patients who are less than 18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Hospital
Indianapolis, Indiana, 46202
About this study
Official title: How Pathologic Features of Chronic Pancreatitis Corelate With Endoscopic Ultrasound (EUS) Criteria for Diagnosing Chronic Pancreatitis
In this research project the investigators intend to find out if Endoscopic Ultrasound (EUS) criteria for diagnosing chronic pancreatitis can be correlated with pathologic characteristics of tissues taken from pancreas of patients with suspected chronic pancreatitis.
This will be a retrospective study which will examine results from biopsy specimens and endoscopic ultrasound findings in suspected chronic pancreatitis.
- Conditions
- Chronic Pancreatitis
- Keywords
- chronic pancreatitis
- Medical subject headings
- Pancreatitis, Chronic
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 |
|---|---|---|
| chronic pancreatitis | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startFeb 2009
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies 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
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442441
- Sponsor's protocol ID
- 0809-67
- Status last verified
- Sep 2014
- First submitted
- 26 Sep 2011
- Last updated
- 5 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Pathologic Features of Chronic Pancreatitis Corelate With Endoscopic Ultrasound (EUS) Criteria for Diagnosing Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT01442441
- Acronym / sponsor ID
- 0809-67
- Conditions
- Chronic Pancreatitis
- Keywords
- chronic pancreatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 28 Sep 2011 (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.
In this research project the investigators intend to find out if Endoscopic Ultrasound (EUS) criteria for diagnosing chronic pancreatitis can be correlated with pathologic characteristics of tissues taken from pancreas of patients with suspected chronic pancreatitis.
This will be a retrospective study which will examine results from biopsy specimens and endoscopic ultrasound findings in suspected chronic pancreatitis.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic pancreatitis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective surgery cases who had chronic pancreatitis
Key inclusion criteria (1 listed)
- will include all patients who consented to have both EUS and had biopsy taken for tissue diagnosis.
Key exclusion criteria (1 listed)
- Will exclude patients who are less than 18 years
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
Not reported in the source record.
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 5 Sep 2014.
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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 Chronic Pancreatitis, 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 1 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 5 Sep 2014. 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.
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 Sep 2014.