Gallbladder DiseaseNCT00609726
Prospective Evaluation of Idiopathic Pancreatitis: Role of Endoscopic Ultrasonography
An observational study of Gallbladder Disease and Pancreatitis, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of the study is to determine the best evaluation for patients with idiopathic (unexplained) pancreatitis. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gallbladder Disease, Pancreatitis
- How many people
- 199 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Dec 2015
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and women diagnosed with unexplained pancreatitis.
Who may be able to join
- All patients referred to the principal investigator for unexplained pancreatitis will be enrolled.
Who cannot join
- There are no gender nor racial exclusion.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to determine the best evaluation for patients with idiopathic (unexplained) pancreatitis.
Read the detailed description
The study evaluates the role of endoscopic ultrasonography, given that the minimally invasive procedures can diagnosis gallbladder disease as well as pancreatitis abnormalities.
- Conditions
- Gallbladder Disease, Pancreatitis
- Keywords
- Endoscopic Ultrasonography, Pancreatitis, EUS
- Medical subject headings
- Gallbladder Diseases, Pancreatitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of current clinical practice for patients with idiopathic pancreatitis
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startDec 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gallbladder DiseaseStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles M Wilcox, M.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609726
- Sponsor's protocol ID
- X040909004
- Other IDs
- 228552
- Status last verified
- Jan 2015
- First submitted
- 24 Jan 2008
- Last updated
- 25 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wilcox CM, Seay T, Kim H, Varadarajulu S. Prospective Endoscopic Ultrasound-Based Approach to the Evaluation of Idiopathic Pancreatitis: Causes, Response to Therapy, and Long-term Outcome. Am J Gastroenterol. 2016 Sep;111(9):1339-48. doi: 10.1038/ajg.2016.240. Epub 2016 Jun 21.
PubMed 27325219
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Idiopathic Pancreatitis: Role of Endoscopic Ultrasonography
- ClinicalTrials.gov ID
- NCT00609726
- Acronym / sponsor ID
- X040909004
- Conditions
- Gallbladder Disease, Pancreatitis
- Keywords
- Endoscopic Ultrasonography, Pancreatitis, EUS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Feb 2008 (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 the study is to determine the best evaluation for patients with idiopathic (unexplained) pancreatitis.
Detailed description
The study evaluates the role of endoscopic ultrasonography, given that the minimally invasive procedures can diagnosis gallbladder disease as well as pancreatitis abnormalities.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women diagnosed with unexplained pancreatitis.
Key inclusion criteria (1 listed)
- All patients referred to the principal investigator for unexplained pancreatitis will be enrolled.
Key exclusion criteria (1 listed)
- There are no gender nor racial exclusion.
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
Evaluation of current clinical practice for patients with idiopathic pancreatitis
Time frame: 3 hours
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 25 Jan 2016.
- Derived from this study: PubMed 27325219Wilcox CM, Seay T, Kim H, Varadarajulu S. Prospective Endoscopic Ultrasound-Based Approach to the Evaluation of Idiopathic Pancreatitis: Causes, Response to Therapy, and Long-term Outcome. Am J Gastroenterol. 2016 Sep;111(9):1339-48. doi: 10.1038/ajg.2016.240. Epub 2016 Jun 21.
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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.
Charles M Wilcox, M.D. principal investigator
University of Alabama at Birmingham
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 Gallbladder Disease and Pancreatitis, run by University of Alabama at Birmingham 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 25 Jan 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 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?
Evaluation of current clinical practice for patients with idiopathic pancreatitis (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00609726, which also lists 1 linked publication.
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 25 Jan 2016.