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

NCT ID: NCT01703026

Last Updated: 2012-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changi General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Changi General Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

References

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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.

Reference Type BACKGROUND
PMID: 17580363 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18956589 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1612375 (View on PubMed)

Other Identifiers

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CTC0900328

Identifier Type: -

Identifier Source: org_study_id