Contrast EUS of the Pancreas

NCT02863770 | Unknown DMC

• 1 other identifier: HS-15-00784
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

endosonography

Outcome Measures

Primary Outcomes (1)

• The yield of EUS versus contrast EUS to diagnose pancreas cystic lesions, mass lesion, and origin of pancreatitis.

  The endoscopist will perform conventional EUS and classify the lesion as described below, this will be recorded by the research assistant prior to contrast EUS. Contrast will then be administered and the classification of contrast EUS recorded in real time. The gold standard to calculate the yields of the modality will be on pathology and clinical diagnosis at three and six months. Additionally we will assess whether contrast impacted assessment of size and diagnosis.

  6 months

Secondary Outcomes (2)

• Targeting of FINE NEEDLE ASPIRATION (FNA) of pancreas lesions.

  6 months

• Quantitative Parameters of Pancreas Lesions

  6 months

Study Arms (1)

Contrast EUS

EXPERIMENTAL

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

Other: EUS enhanced with contrast to evaluate pancreas

Interventions

EUS enhanced with contrast to evaluate pancreas OTHER

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

Contrast EUS

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Los Angeles County Hospital

Los Angeles, California, 90033, United States

RECRUITING

Related Publications (4)

• Napoleon B, Alvarez-Sanchez MV, Gincoul R, Pujol B, Lefort C, Lepilliez V, Labadie M, Souquet JC, Queneau PE, Scoazec JY, Chayvialle JA, Ponchon T. Contrast-enhanced harmonic endoscopic ultrasound in solid lesions of the pancreas: results of a pilot study. Endoscopy. 2010 Jul;42(7):564-70. doi: 10.1055/s-0030-1255537. Epub 2010 Jun 30.

  PMID: 20593334 BACKGROUND

• Kitano M, Kudo M, Yamao K, Takagi T, Sakamoto H, Komaki T, Kamata K, Imai H, Chiba Y, Okada M, Murakami T, Takeyama Y. Characterization of small solid tumors in the pancreas: the value of contrast-enhanced harmonic endoscopic ultrasonography. Am J Gastroenterol. 2012 Feb;107(2):303-10. doi: 10.1038/ajg.2011.354. Epub 2011 Oct 18.

  PMID: 22008892 BACKGROUND

• Saftoiu A, Vilmann P, Dietrich CF, Iglesias-Garcia J, Hocke M, Seicean A, Ignee A, Hassan H, Streba CT, Ioncica AM, Gheonea DI, Ciurea T. Quantitative contrast-enhanced harmonic EUS in differential diagnosis of focal pancreatic masses (with videos). Gastrointest Endosc. 2015 Jul;82(1):59-69. doi: 10.1016/j.gie.2014.11.040. Epub 2015 Mar 16.

  PMID: 25792386 BACKGROUND

• King KG, Gulati M, Malhi H, Hwang D, Gill IS, Cheng PM, Grant EG, Duddalwar VA. Quantitative assessment of solid renal masses by contrast-enhanced ultrasound with time-intensity curves: how we do it. Abdom Imaging. 2015 Oct;40(7):2461-71. doi: 10.1007/s00261-015-0468-y.

  PMID: 26036794 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatitis; Pancreatic Cyst

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Cysts

Central Study Contacts

Jessica Serna, BS

CONTACT

323 409 6939; Jessica.Sern@med.usc.edu

James Buxbaum, MD

CONTACT

323 409 5371; jbuxbaum@usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Medicine

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 11, 2016
• Study Start: July 1, 2016
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: March 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)