Contrast EUS of the Pancreas
Status unconfirmed · Not applicable
Conditions studied: Pancreatic Neoplasms, Pancreatitis, Pancreatic Cyst
In brief
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).
Key facts
- Study ID
- NCT02863770
- Run by
- University of Southern California
- People needed
- 150
- Starts
- 2016-07-01
- Expected to finish
- 2024-04-01
- Last updated by the study team
- 2023-03-06
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients undergoing endoscopic ultrasound for standard pancreatic indications.
- Patients must have unexplained pancreatitis, pancreas mass(es), or pancreatic cystic lesions (>1cm or worrisome features on imaging).
You may not qualify if…
- 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.
- Patients with an allergy to Definity will be excluded.
Where it is running
- Los Angeles County Hospital — Los Angeles, California, United States (enrolling)
Full record on ClinicalTrials.gov
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