Contrast EUS for Pancreatic Conditions

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Southern California

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Research Team

Eligibility Criteria

This trial is for adults with unexplained pancreatitis, pancreatic masses, or cysts larger than 1cm or with concerning features. It's not for those under 18, pregnant or breastfeeding women, people with unstable heart disease, allergies to the contrast agent Definity, or certain heart shunts.

Inclusion Criteria

I am scheduled for an endoscopic ultrasound for my pancreas.

I have unexplained pancreatitis or a suspicious mass or cyst in my pancreas.

Exclusion Criteria

You are allergic to Definity.

I do not have unstable heart disease.

You have a certain type of heart condition that could pose a small risk during the study.

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Treatment Details

Interventions

EUS enhanced with contrast to evaluate pancreas (Procedure)

Trial OverviewThe study tests if adding a contrast agent to Endoscopic Ultrasound (EUS) improves diagnosis of pancreatic conditions. Participants will undergo standard EUS and then EUS enhanced with contrast to see if it better identifies lesions and guides biopsies.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Contrast EUSExperimental Treatment1 Intervention

Undergoing EUS for pancreatic indication (cyst, pancreatitis, mass)