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

NCT01703026 | Completed

• 1 other identifier: CTC0900328
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 50 subjects will be enrolled. The study population will be drawn from patients referred for EUS evaluation on basis of suspected pancreatic cancer. These patients could be either from clinics or from the hospital wards.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, Singapore

Location

Related Publications (3)

• 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. doi: 10.1002/cncr.22852.

  PMID: 17580363 BACKGROUND

• Ang TL. Endoscopic ultrasound: moving from diagnostics to therapeutics. J Dig Dis. 2008 Aug;9(3):117-28. doi: 10.1111/j.1751-2980.2008.00333.x.

  PMID: 18956589 BACKGROUND

• 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. doi: 10.1016/s0016-5107(92)70326-5.

  PMID: 1612375 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2012
• First Posted: October 10, 2012
• Study Start: August 1, 2009
• Study Completion: October 1, 2011
• Last Updated: October 10, 2012

Record last verified: 2012-10

Locations

SG (1)