NCT03556501

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 14, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

1.1 years

First QC Date

April 24, 2018

Last Update Submit

May 25, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    one year

Interventions

EndoscopyDIAGNOSTIC_TEST

Purpose of this study is to create a prospective registry of patients with pancreatic collections and their imaging studies

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients at Northshore-LIJ being evaluate by the gastroenterology service

You may qualify if:

  • patients who are known to have a pancreatic fluid collection after an episode of acute pancreatitis
  • age greater than 18 years

You may not qualify if:

  • pregnant woman
  • age \<18 years
  • prisoners
  • other institutionalized individuals
  • patients who are decisionally impaired

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Long Island Jewish Hospital

New Hyde Park, New York, 11040, United States

Location

Related Publications (4)

  • 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.

    PMID: 23100216BACKGROUND
  • Bollen 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.

    PMID: 22186977BACKGROUND
  • Singh 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.

    PMID: 21893128BACKGROUND
  • Tyberg 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.

    PMID: 26900288BACKGROUND

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Arvind Trindade, MD

    Northwell Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2018

First Posted

June 14, 2018

Study Start

October 1, 2018

Primary Completion

October 30, 2019

Study Completion

October 30, 2019

Last Updated

May 30, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations