Contrast Enhanced EUS In The Evaluation Of Pancreatic Cancer And Pancreatic Masses

Study Overview

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

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.

N/A

Pancreatic Cancer

CTC0900328

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2012-10-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2012-10-09
First Submitted that Met QC Criteria 2012-10-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2012-10-10
First Posted (ESTIMATED) 2012-10-10	Results First Posted N/A	Last Verified 2012-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
21 Years

Accepts Healthy Volunteers:

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

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
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.
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.

Learn

Resources

Patients

Caregivers

Clinical Trial Record