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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01703026
• Other study ID #: CTC0900328
• Status: Completed
• Phase: N/A
• First received: October 5, 2012
• Last updated: October 9, 2012
• Start date: August 2009
• Est. completion date: October 2011

Study information

• Verified date: October 2012
• Source: Changi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Changi General Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (3)

Ang TL. Endoscopic ultrasound: moving from diagnostics to therapeutics. J Dig Dis. 2008 Aug;9(3):117-28. Review. — View Citation

Bilimoria KY, Bentrem DJ, Ko CY, Ritchey J, Stewart AK, Winchester DP, Talamonti MS. Validation of the 6th edition AJCC Pancreatic Cancer Staging System: report from the National Cancer Database. Cancer. 2007 Aug 15;110(4):738-44. — View Citation

Snady H, Cooperman A, Siegel J. Endoscopic ultrasonography compared with computed tomography with ERCP in patients with obstructive jaundice or small peri-pancreatic mass. Gastrointest Endosc. 1992 Jan-Feb;38(1):27-34. — View Citation