RECRUITING

Contrast EUS of the Pancreas

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

RATIONALE: Endoscopic Ultrasound (EUS) is the leading method to evaluate the pancreas but there may be difficulty characterizing small lesions, tumors which are not adenocarcinomas and neoplasia in the setting of pancreatitis. INTERVENTION: The innovation in this project will be the addition of intravenous contrast to standard EUS examination if the pancreas. PURPOSE: The aim is to determine if contrast enhances the ability of EUS to accurately diagnose lesions and target biopsies, and to define the quantitative features of this method. STUDY POPULATION:The population will include patients with pancreas cysts, masses, and inflammation presenting for EUS as part of standard clinical care. METHODOLOGY: This will be a prospective tandem trial involving conventional EUS, followed by EUS with contrast, followed by subsequent quantitative processing of contrast EUS imaging. ENDOINTS:Study endpoints will include the yield contrast EUS to evaluate pancreas cysts, masses, and inflammation. The impact of contrast EUS to better target the FNA of the chosen lesion will be assessed. Intra and interobserver variability will be assessed by comparing conventional EUS and contrast EUS of each case in a random order (intraobserver agreement) and among a group of blinded endosonographers (interobserver agreement).

Official Title

Prospective Controlled Trial of Contrast Enhanced Endoscopic Ultrasound for Evaluation of Pancreas Lesions

Quick Facts

Study Start:2016-07
Study Completion:2024-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02863770

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients undergoing endoscopic ultrasound for standard pancreatic indications.
  2. * Patients must have unexplained pancreatitis, pancreas mass(es), or pancreatic cystic lesions (\>1cm or worrisome features on imaging).
  1. * Patients \<18 years of age, pregnant women, and lactating mothers will be excluded. Subjects with unstable ischemic disease will be excluded. Additionally, those with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts will be excluded given theoretical (though clinically insignificant) risk of embolization.
  2. * Patients with an allergy to Definity will be excluded.

Contacts and Locations

Study Contact

Jessica Serna, BS
CONTACT
323 409 6939
Jessica.Sern@med.usc.edu
James Buxbaum, MD
CONTACT
323 409 5371
jbuxbaum@usc.edu

Study Locations (Sites)

Los Angeles County Hospital
Los Angeles, California, 90033
United States

Collaborators and Investigators

Sponsor: University of Southern California

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-07
Study Completion Date2024-04

Study Record Updates

Study Start Date2016-07
Study Completion Date2024-04

Terms related to this study

Keywords Provided by Researchers

  • endosonography

Additional Relevant MeSH Terms

  • Pancreatic Neoplasms
  • Pancreatitis
  • Pancreatic Cyst