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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Changi General Hospital
ClinicalTrials.gov Identifier:
NCT01703026
First received: October 5, 2012
Last updated: October 9, 2012
Last verified: October 2012
  Purpose

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.


Condition
Pancreatic Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Contrast Enhanced EUS Using Definity in the Evaluation of Pancreatic Cancer and Pancreatic Masses

Resource links provided by NLM:


Further study details as provided by Changi General Hospital:

Enrollment: 33
Study Start Date: August 2009
Study Completion Date: October 2011
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01703026

Locations
Singapore
Changi General Hospital
Singapore, Singapore
Sponsors and Collaborators
Changi General Hospital
  More Information

Publications:
Responsible Party: Changi General Hospital
ClinicalTrials.gov Identifier: NCT01703026     History of Changes
Other Study ID Numbers: CTC0900328
Study First Received: October 5, 2012
Last Updated: October 9, 2012
Health Authority: Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014