Prevalence of Pancreatic Cysts During Routine Endoscopic Ultra Sound

Pancreatic Cysts Clinical Trial

Official title:

Prevalence of Pancreatic Cysts During Routine EUS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01624363
• Other study ID #: 0906-23
• Status: Completed
• Phase: N/A
• First received: June 18, 2012
• Last updated: April 18, 2017
• Start date: September 2009
• Est. completion date: June 2015

Study information

• Verified date: August 2016
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators are interested in performing a detailed examination of the pancreas via EUS (Endoscopic Ultra Sound)for patients referred for a non-pancreatic condition. The hypothesis is to make a statistical determination of how many pancreatic cysts the investigators discover incidentally.

Description:

The prevalence of incidental pancreatic cysts discovered during EUS. (see data tables)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: June 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The inclusion criteria included: patients >18 years old with decision making capacity referred for EUS for any other indication other than the evaluation of a known pancreatic cyst, solid mass, or suspected mass.

Exclusion Criteria:

• Any known history or evidence of the following from any previous imaging study:

pancreatic cyst, solid mass, suspected pancreatic mass, dilated main pancreatic duct

• Previous surgical resection of any portion of the upper GI tract such as Billroth II that would not permit complete EUS exam of the pancreas

• Laboratory and/or clinical evidence of ongoing acute pancreatitis

• Previous pancreatic surgical resection

• Pregnancy

• Incarceration

• High risk for sedation

• Coagulopathy and/or thrombocytopenia

• The patients underwent a complete EUS examination of the pancreas.

Related Conditions & MeSH terms

• Cysts
• Pancreatic Cyst
• Pancreatic Cysts

Locations

Country	Name	City	State
United States	University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sey MS, Teagarden S, Settles D, McGreevy K, Coté GA, Sherman S, McHenry L, LeBlanc JK, Al-Haddad M, DeWitt JM. Prospective Cross-Sectional Study of the Prevalence of Incidental Pancreatic Cysts During Routine Outpatient Endoscopic Ultrasound. Pancreas. 2015 Oct;44(7):1130-3. doi: 10.1097/MPA.0000000000000408. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Pancreatic Cysts During Routine EUS	The purpose of this study is to identify the prevalence of pancreatic cysts in patients undergoing EUS for non-pancreatic indications .	48 months