Contrast Enhanced Endoscopic Ultrasound in Pancreas Lesions
The Role of Contrast Enhanced Endoscopic Ultrasound for Evaluation of Pancreas Lesions
1 other identifier
interventional
200
1 country
1
Brief Summary
The purpose of this study is to determine whether quantitative contrast-enhanced endoscopic ultrasound (CE-EUS) improves the evaluation of pancreas tumors and precursor lesions, including cysts, compared to conventional endoscopic ultrasound.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2020
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 26, 2020
CompletedFirst Submitted
Initial submission to the registry
March 12, 2020
CompletedFirst Posted
Study publicly available on registry
March 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedDecember 20, 2023
December 1, 2023
5.8 years
March 12, 2020
December 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
The results obtained by 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, which will be recorded by the research assistant prior to CE-EUS. Contrast will then be administered and the classification of CE-EUS will be recorded in real time. Using pathology and one-year clinical follow-up as the gold standard, the yields of the modality will be calculated. In addition, we will evaluate whether the use of CE-EUS impacted assessment of size and diagnosis.
12 months
Secondary Outcomes (1)
Quantitative Parameters of Pancreas Lesions
3 months, 6 months, 12 months
Study Arms (1)
Contrast EUS
EXPERIMENTALUndergoing EUS for pancreatic indication (cyst, pancreatitis, mass)
Interventions
Patients will receive intravenous contrast during EUS to assess whether it improves the evaluation of pancreas.
Eligibility Criteria
You may qualify if:
- Patients undergoing endoscopic ultrasound for pancreatic indications
- Patients must have unexplained pancreatitis, pancreas mass(es), or pancreatic cystic lesions or worrisome clinical, imaging or laboratory findings
You may not qualify if:
- Patients \<18 years of age, pregnant women, and lactating mothers will be excluded.
- Subjects with unstable cardiopulmonary condition will be excluded (acute myocardial infarction, acute coronary syndromes, worsening or unstable heart failure, or serious ventricular arrhythmias)
- Patients 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 a history of allergy to Lumason will be excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Srinivas Gaddam, MD
Cedars-Sinai Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
March 12, 2020
First Posted
March 27, 2020
Study Start
February 26, 2020
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
December 20, 2023
Record last verified: 2023-12