Chronic PancreatitisNCT02868047
Establishing Standards for Normal Pancreatic EUS
An observational study of Chronic Pancreatitis, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
There is tremendous variability in regard to provider perception of findings on EUS for chronic pancreatitis. This study performs tandem EUS exams between expert endosonogrpahers to determine the validity of minimal standard criteria. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- Endoscopic Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to May 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will include patients who are scheduled for an elective EUS for evaluation of their pancreas. Patients will be those with and without suspected chronic pancreatitis.
Who may be able to join
- Undergoing upper EUS for evaluation of the pancreas
Who cannot join
- pregnancy
- age less than 18
- inability to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
There is tremendous variability in regard to provider perception of findings on EUS for chronic pancreatitis. This study performs tandem EUS exams between expert endosonogrpahers to determine the validity of minimal standard criteria.
Read the detailed description
Chronic pancreatitis is a very challenging disease to diagnose as their is no gold standard for diagnosis. Increasingly, endoscopic ultrasound (EUS) has been used as a means of diagnosing chronic pancreatitis. However, there are questions about whether intra-rater reliability and/or validity are high enough to warrant using EUS to make the diagnosis of chronic pancreatitis.
The purpose of this observational study is to determine the degree of correlation between two expert endosonographers in evaluating minimal standard criteria (MST) in the same patient during the same EUS exam. Patients both with and without chronic pancreatitis will be included in the study to try and determine the validity and reliability of back-to-back EUS examinations.
- Conditions
- Chronic Pancreatitis
- Being tested
- Endoscopic Ultrasound
- Keywords
- chronic pancreatitis, endoscopic ultrasound
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic UltrasoundProcedure or surgery
Patients will undergo elective upper endoscopic ultrasound to evaluate the pancreas in patients both with and without chronic pancreatitis
| Study group | Role | What they receive |
|---|---|---|
| Suspected Chronic Pancreatitis | Included patients will be those scheduled for an upper endoscopic ultrasound examination with suspected chronic pancreatitis Receives: Procedure: Endoscopic Ultrasound | |
| NOT Suspected Chronic Pancreatitis | Included patients will be those scheduled for an upper endoscopic ultrasound examination without suspected chronic pancreatitis. Receives: Procedure: Endoscopic Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Hyperechoic Strands
Measured: Day 1
Number of Patients with Hyperechoic Foci
Measured: Day 1
Number of Patients with Lobular Contour
Measured: Day 1
Number of Patients with Cysts
Measured: Day 1
Number of Patients with Duct Irregularity
Measured: Day 1
Number of Patients with Ductal Calculi
Measured: Day 1
Number of Patients with Hyperechoic Duct Wall
Measured: Day 1
Number of Patients with Dilated Dilated Side Branches
Measured: Day 1
Number of Patients with Dilated Pancreatic Duct
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startSep 2010
- Primary completionSep 2014
- Study completionMay 2015
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 Dartmouth-Hitchcock Medical CenterThe 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 only
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Gardner, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868047
- Sponsor's protocol ID
- 21516
- Status last verified
- Aug 2016
- First submitted
- 2 Jan 2014
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Standards for Normal Pancreatic EUS
- ClinicalTrials.gov ID
- NCT02868047
- Acronym / sponsor ID
- 21516
- Conditions
- Chronic Pancreatitis
- Keywords
- chronic pancreatitis, endoscopic ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 16 Aug 2016 (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.
There is tremendous variability in regard to provider perception of findings on EUS for chronic pancreatitis. This study performs tandem EUS exams between expert endosonogrpahers to determine the validity of minimal standard criteria.
Detailed description
Chronic pancreatitis is a very challenging disease to diagnose as their is no gold standard for diagnosis. Increasingly, endoscopic ultrasound (EUS) has been used as a means of diagnosing chronic pancreatitis. However, there are questions about whether intra-rater reliability and/or validity are high enough to warrant using EUS to make the diagnosis of chronic pancreatitis.
The purpose of this observational study is to determine the degree of correlation between two expert endosonographers in evaluating minimal standard criteria (MST) in the same patient during the same EUS exam. Patients both with and without chronic pancreatitis will be included in the study to try and determine the validity and reliability of back-to-back EUS examinations.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suspected Chronic Pancreatitis | – | Procedure: Endoscopic UltrasoundIncluded patients will be those scheduled for an upper endoscopic ultrasound examination with suspected chronic pancreatitis |
| NOT Suspected Chronic Pancreatitis | – | Procedure: Endoscopic UltrasoundIncluded patients will be those scheduled for an upper endoscopic ultrasound examination without suspected chronic pancreatitis. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include patients who are scheduled for an elective EUS for evaluation of their pancreas. Patients will be those with and without suspected chronic pancreatitis.
Key inclusion criteria (1 listed)
- Undergoing upper EUS for evaluation of the pancreas
Key exclusion criteria (3 listed)
- pregnancy
- age less than 18
- inability to provide written informed consent
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 |
|---|---|---|
| Endoscopic UltrasoundPatients will undergo elective upper endoscopic ultrasound to evaluate the pancreas in patients both with and without chronic pancreatitis | Procedure or surgery | NOT Suspected Chronic Pancreatitis, Suspected Chronic Pancreatitis |
Primary outcome
Number of Patients with Hyperechoic Strands
Time frame: Day 1
Number of Patients with Hyperechoic Foci
Time frame: Day 1
Number of Patients with Lobular Contour
Time frame: Day 1
Number of Patients with Cysts
Time frame: Day 1
Number of Patients with Duct Irregularity
Time frame: Day 1
Number of Patients with Ductal Calculi
Time frame: Day 1
Number of Patients with Hyperechoic Duct Wall
Time frame: Day 1
Number of Patients with Dilated Dilated Side Branches
Time frame: Day 1
Number of Patients with Dilated Pancreatic Duct
Time frame: Day 1
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 16 Aug 2016.
- Individual participant dataSharing planned: No
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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 Dartmouth-Hitchcock Medical Center 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 3 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 16 Aug 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?
Number of Patients with Hyperechoic Strands (time frame: Day 1). The study lists 9 primary outcomes in all. 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 16 Aug 2016.