Pancreas NecrosisNCT03556501
Imaging Modalities for Pancreatic Collections
An observational study of Pancreas Necrosis, run by Northwell Health at 1 site in United States.
Trial summary
The purpose of this project is to provide appropriate administrative and technical supports for the warehousing and use of imaging data in pancreatic necrosis data for research purposes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreas Necrosis
- What is being tested?
- Endoscopy
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 30 Oct 2019
- 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 at Northshore-LIJ being evaluate by the gastroenterology service
Who may be able to join
- patients who are known to have a pancreatic fluid collection after an episode of acute pancreatitis
- age greater than 18 years
Who cannot join
- pregnant woman
- age <18 years
- prisoners
- other institutionalized individuals
- patients who are decisionally impaired
Trial locations and contacts
1 site in 1 country.
United States1 site
Long Island Jewish Hospital
New Hyde Park, New York, 11040
About this study
Official title: Comparative Registry of Structural Features of Pancreatic Collections Found on Cross Sectional Imaging
The purpose of this project is to provide appropriate administrative and technical supports for the warehousing and use of imaging data in pancreatic necrosis data for research purposes.
Read the detailed description
The aim of this study is to create a prospective registry of patients with pancreatic collections and their imaging studies (including CT, MRI, EUS, and direct endoscopic visualization) to compare these techniques, develop standardized methods for analyzing these imaging studies, and use this information to enhance management of patients with pancreatic collections. There is very limited published literature on these peripancreatic lesions that compares all three of these modalities and thus we aim to study it in detail.
- Conditions
- Pancreas Necrosis
- Being tested
- Endoscopy
- Medical subject headings
- Pancreatitis, Acute Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoscopyDiagnostic test
Purpose of this study is to create a prospective registry of patients with pancreatic collections and their imaging studies
What is being measured
The primary outcome is the main question the study is designed to answer.
to define severity of pancreatitis as mild, moderate, severe; based on amount of debris in the pancreatic lesion (mild: < 30% debris, moderate: 30-50% debris, severe: >50% debris)
Pancreatic lesions will be evaluated using CT, MRI, EUS, endoscopy to assess for severeity based on amount of debris in the pancreatic lesion
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start1 Oct 2018
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Why it stopped: Lack of enrollment numbers - participants are no longer being examined
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pancreas NecrosisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arvind Trindade, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556501
- Sponsor's protocol ID
- 18-0228
- Status last verified
- May 2023
- First submitted
- 24 Apr 2018
- Last updated
- 30 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
PubMed 23100216Bollen TL, Singh VK, Maurer R, Repas K, van Es HW, Banks PA, Mortele KJ. A comparative evaluation of radiologic and clinical scoring systems in the early prediction of severity in acute pancreatitis. Am J Gastroenterol. 2012 Apr;107(4):612-9. doi: 10.1038/ajg.2011.438. Epub 2011 Dec 20.
PubMed 22186977Singh VK, Bollen TL, Wu BU, Repas K, Maurer R, Yu S, Mortele KJ, Conwell DL, Banks PA. An assessment of the severity of interstitial pancreatitis. Clin Gastroenterol Hepatol. 2011 Dec;9(12):1098-103. doi: 10.1016/j.cgh.2011.08.026. Epub 2011 Sep 3.
PubMed 21893128Tyberg A, Karia K, Gabr M, Desai A, Doshi R, Gaidhane M, Sharaiha RZ, Kahaleh M. Management of pancreatic fluid collections: A comprehensive review of the literature. World J Gastroenterol. 2016 Feb 21;22(7):2256-70. doi: 10.3748/wjg.v22.i7.2256.
PubMed 26900288
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Registry of Structural Features of Pancreatic Collections Found on Cross Sectional Imaging
- ClinicalTrials.gov ID
- NCT03556501
- Acronym / sponsor ID
- 18-0228
- Conditions
- Pancreas Necrosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of enrollment numbers - participants are no longer being examined
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 14 Jun 2018 (actual)
- 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 project is to provide appropriate administrative and technical supports for the warehousing and use of imaging data in pancreatic necrosis data for research purposes.
Detailed description
The aim of this study is to create a prospective registry of patients with pancreatic collections and their imaging studies (including CT, MRI, EUS, and direct endoscopic visualization) to compare these techniques, develop standardized methods for analyzing these imaging studies, and use this information to enhance management of patients with pancreatic collections. There is very limited published literature on these peripancreatic lesions that compares all three of these modalities and thus we aim to study it in detail.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at Northshore-LIJ being evaluate by the gastroenterology service
Key inclusion criteria (2 listed)
- patients who are known to have a pancreatic fluid collection after an episode of acute pancreatitis
- age greater than 18 years
Key exclusion criteria (5 listed)
- pregnant woman
- age <18 years
- prisoners
- other institutionalized individuals
- patients who are decisionally impaired
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 |
|---|---|---|
| EndoscopyPurpose of this study is to create a prospective registry of patients with pancreatic collections and their imaging studies | Diagnostic test | – |
Primary outcome
to define severity of pancreatitis as mild, moderate, severe; based on amount of debris in the pancreatic lesion (mild: < 30% debris, moderate: 30-50% debris, severe: >50% debris)
Time frame: one year
Pancreatic lesions will be evaluated using CT, MRI, EUS, endoscopy to assess for severeity based on amount of debris in the pancreatic lesion
Results and safety
The study was stopped early (reason given: Lack of enrollment numbers - participants are no longer being examined). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Background: PubMed 23100216Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
- Background: PubMed 22186977Bollen TL, Singh VK, Maurer R, Repas K, van Es HW, Banks PA, Mortele KJ. A comparative evaluation of radiologic and clinical scoring systems in the early prediction of severity in acute pancreatitis. Am J Gastroenterol. 2012 Apr;107(4):612-9. doi: 10.1038/ajg.2011.438. Epub 2011 Dec 20.
- Background: PubMed 21893128Singh VK, Bollen TL, Wu BU, Repas K, Maurer R, Yu S, Mortele KJ, Conwell DL, Banks PA. An assessment of the severity of interstitial pancreatitis. Clin Gastroenterol Hepatol. 2011 Dec;9(12):1098-103. doi: 10.1016/j.cgh.2011.08.026. Epub 2011 Sep 3.
- Background: PubMed 26900288Tyberg A, Karia K, Gabr M, Desai A, Doshi R, Gaidhane M, Sharaiha RZ, Kahaleh M. Management of pancreatic fluid collections: A comprehensive review of the literature. World J Gastroenterol. 2016 Feb 21;22(7):2256-70. doi: 10.3748/wjg.v22.i7.2256.
- 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.
Arvind Trindade, MD principal investigator
Northwell Health
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 Pancreas Necrosis, run by Northwell Health 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 5 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: stopped early, as of the sponsor's last update on 30 May 2023. 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: Lack of enrollment numbers - participants are no longer being examined). 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.
What does the primary outcome measure?
to define severity of pancreatitis as mild, moderate, severe; based on amount of debris in the pancreatic lesion (mild: < 30% debris, moderate: 30-50% debris, severe: >50% debris) (time frame: one year). 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 NCT03556501, which also lists 4 linked publications.
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 30 May 2023.