Clinical trial · Interventional
Contrast EUS of the Pancreas
Prospective Controlled Trial of Contrast Enhanced Endoscopic Ultrasound for Evaluation of Pancreas Lesions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cyst | — | UNRESOLVED | — |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pancreatitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS enhanced with contrast to evaluate pancreas | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Contrast EUS
- description
- Undergoing EUS for pancreatic indication (cyst, pancreatitis, mass)
- interventionNames
- Other: EUS enhanced with contrast to evaluate pancreas
Primary outcomes (1)
- measure
- The yield of EUS versus contrast EUS to diagnose pancreas cystic lesions, mass lesion, and origin of pancreatitis.
- timeFrame
- 6 months
- description
- 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.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDNapoleon 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
- BACKGROUNDKitano 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
- BACKGROUNDSaftoiu 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
- BACKGROUNDKing 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