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

October 9, 2012 updated by: Changi General Hospital

Contrast Enhanced EUS Using Definity 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

33

Contacts and Locations

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

Study Locations

  • Singapore
      • Singapore, Singapore
        • Changi General Hospital

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.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

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

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Collaborators and Investigators

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

Sponsor

Changi General Hospital

Publications and helpful links

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

General Publications

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 Major Dates

Study Start

August 1, 2009

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

October 5, 2012

First Submitted That Met QC Criteria

October 9, 2012

First Posted (Estimate)

October 10, 2012

Study Record Updates

Last Update Posted (Estimate)

October 10, 2012

Last Update Submitted That Met QC Criteria

October 9, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTC0900328

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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