Contrast Enhanced EUS in the Evaluation of Pancreatic Cancer and Pancreatic Masses

Completed

• Conditions: Pancreatic Cancer

• Registration Number: NCT01703026
• Lead Sponsor: Changi General Hospital

Brief Summary

Contrast enhanced EUS with the sonographic contrast agent DEFINITY™ has the potential to detect pancreatic cancer at an earlier stage, to improve current method of T staging and assessment of surgical resectability and also to distinguish between benign and malignant pancreatic masses. All these will translate into better clinical outcome, and also avoid unnecessary surgery in situations of unresectable cancers.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study Completion: 2011-10
• Status Verified: 2012-10
• Study First Submitted: 2012-10-05
• Study First Submitted QC: 2012-10-09
• Last Update Submitted: 2012-10-09
• Study First Posted: 2012-10-10
• Last Update Posted: 2012-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Consecutive patients over a 1-year period referred for EUS examination due to suspected pancreatic lesions will be enrolled.
• Age 21 years and above.
• Ability to provide informed consent

Exclusion Criteria

Patients with clinical conditions that preclude the use of DEFINITY™ will be excluded. These conditions are:

• Right-to-left, bi-directional, or transient right-to-left cardiac shunts;
• Worsening or clinically unstable congestive heart failure;
• Acute myocardial infarction or acute coronary syndromes;
• Serious ventricular arrhythmias or high risk for arrhythmias due to prolongation of the QT interval;
• Respiratory failure;
• Severe emphysema, pulmonary emboli or other conditions that cause pulmonary hypertension due to compromised pulmonary arterial vasculature;
• Hypersensitivity to DEFINITY™ or its components.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Changi General Hospital; 🇸🇬 Singapore, Singapore