Imaging Modalities for Pancreatic Collections

Pancreas Necrosis Clinical Trial

Official title:

Comparative Registry of Structural Features of Pancreatic Collections Found on Cross Sectional Imaging

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03556501
• Other study ID #: 18-0228
• Status: Terminated
• Start date: October 1, 2018
• Est. completion date: October 30, 2019

Study information

• Verified date: May 2023
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients who are known to have a pancreatic fluid collection after an episode of acute pancreatitis

• age greater than 18 years

Exclusion Criteria:

• pregnant woman

• age <18 years

• prisoners

• other institutionalized individuals

• patients who are decisionally impaired

Related Conditions & MeSH terms

• Necrosis
• Pancreas Necrosis

Intervention

Diagnostic Test:
• Endoscopy
Purpose of this study is to create a prospective registry of patients with pancreatic collections and their imaging studies

Locations

Country	Name	City	State
United States	Long Island Jewish Hospital	New Hyde Park	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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