Chronic PancreatitisNCT01442454
Endoscopic Ultrasound (EUS) Features of Chronic Pancreatitis
An observational study of Chronic Pancreatitis, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to correlate Endoscopic Ultrasound (EUS) criteria for chronic pancreatitis with surgical pathology. 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
- What is being tested?
- chronic pancreatitis
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Sep 2014
- 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: Patients undergoing EUS
Patients who are eligible are individuals who have:
- normal pancreas
- suspected chronic pancreatitis
- established chronic pancreatitis (by ERCP, MRI, previous EUS, CT)
- pancreatic cancer
Patients who are not eligible are individuals who have:
- an uncorrectable coagulopathy (platelet <50,000, INR>1.5), or bleeding disorder, or are unable to discontinue anticoagulation 5-7 days prior to EUS (aspirin and bridging therapy with lovenox are allowed, clopidogrel is not allowed)
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Endoscopic Ultrasound (EUS) Features of Chronic Pancreatitis: A Prospective Correlation With Intraoperative Findings and Surgical Pathology
The purpose of this study is to correlate Endoscopic Ultrasound (EUS) criteria for chronic pancreatitis with surgical pathology.
- Conditions
- Chronic Pancreatitis
- Being tested
- 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.
chronic pancreatitisOther
No intervention, subjects followed through surgery
| Study group | Role | What they receive |
|---|---|---|
| Chronic Pancreatitis | Not described Receives: Other: chronic pancreatitis |
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 startOct 2010
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: The PI left and then the PI who would be taking over has left. No other investigator wanted to take the study since not sponsored
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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442454
- Sponsor's protocol ID
- 1008-15
- Status last verified
- Feb 2016
- First submitted
- 26 Sep 2011
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound (EUS) Features of Chronic Pancreatitis: A Prospective Correlation With Intraoperative Findings and Surgical Pathology
- ClinicalTrials.gov ID
- NCT01442454
- Acronym / sponsor ID
- 1008-15
- Conditions
- Chronic Pancreatitis
- Keywords
- chronic pancreatitis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The PI left and then the PI who would be taking over has left. No other investigator wanted to take the study since not sponsored
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (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.
The purpose of this study is to correlate Endoscopic Ultrasound (EUS) criteria for chronic pancreatitis with surgical pathology.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Pancreatitis | – | Other: chronic pancreatitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing EUS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chronic pancreatitisNo intervention, subjects followed through surgery | Other | Chronic Pancreatitis |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: The PI left and then the PI who would be taking over has left. No other investigator wanted to take the study since not sponsored). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2016.
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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?
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: stopped early, as of the sponsor's last update on 1 Mar 2016. 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 was stopped early (reason given: The PI left and then the PI who would be taking over has left. No other investigator wanted to take the study since not sponsored). Results are not available in the source record.
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 1 Mar 2016.