Recruiting

Contrast EUS

Sponsor:

University of Southern California

Code:

NCT02863770

Conditions

Pancreatic Neoplasms

Pancreatitis

Pancreatic Cyst

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

EUS enhanced with contrast to evaluate pancreas

Study Details

Brief summary:

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).

Conditions

Pancreatic Neoplasms

Pancreatitis

Pancreatic Cyst

Study ID

NCT02863770

Start date

Jul, 2016

Status verified date

Mar, 2023

Completion date

Apr, 2024

Anticipated

Primary completion date

Apr, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Contrast EUS

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

Interventions

EUS enhanced with contrast to evaluate pancreas

Patients will receive intravenous contrast during EUS to assess whether it increases diagnostic yield of the examination

Primary outcome measure

  • The yield of EUS versus contrast EUS to diagnose pancreas cystic lesions, mass lesion, and origin of pancreatitis. [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Los Angeles County Hospital

Recruiting

Los Angeles, California, United States, 90033

Contacts

More Information

Sponsor

University of Southern California

Last update posted

Mar 6, 2023

Last verified

Mar, 2023

Keywords

  • endosonography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2023-03-06.