A Pilot Study of the Effects of Contrast Enhanced Endoscopic Ultrasound on Determining Vascular Involvement in Pancreatic Lesions
Recruitment status was Not yet recruiting
In the US, pancreas cancer is the fifth leading cause of cancer related deaths. It was estimated to have taken 36,800 lives in 2010. Unfortunately, curing pancreatic cancer requires surgical removal. Surgical removal of the pancreas is associated with high morbidity and mortality, as well as high rates of complications. One way to aid surgeons in removing pancreatic tumors is by providing them with a good idea of where the tumor is located and what surrounding structures are involved. This currently happens through many different modalities of imaging; usually computed tomography (CT) and endoscopic ultrasound. Even with these forms of imaging (and sometimes others), surgeons will occasionally open a patient and find that the tumor cannot be removed due to its involvement with surrounding structures.
One way to avoid potentially unnecessary procedures or to help a surgeon navigate this delicate procedure would be to provide more detailed information about the tumor. Several of the techniques currently used to image the body have rapidly advanced over recent years. Typical advancements come through better resolution of the images or contrast to enhance desired parts of the images. Ultrasound has not seen such a two pronged advance. Ultrasound has seen substantial advances in resolution to enhance picture quality, but contrast has not been used clinically to assess pancreatic masses whereas it is for cardiologists to use contrast to look at potential defects in the heart.
The contrast that is used with ultrasound is different from that of CT scans. CT scanners use a dye that can be potentially hazardous. This dye can lead to serious kidney damage in some patients. Ultrasound contrast, on the other hand, is made of small micro bubbles filled with a harmless gas. Because of the way ultrasound works, these micro bubbles reflect the sound waves differently than the surrounding tissue and thus provide contrast between normal tissue and abnormal tissue. The contrast used in this study, Definity, and is the same contrast used by Cardiologists.
The CE-EUS will be used for research purposes only and will not be used for any clinical decision making. The surgeon will be blinded to the results of the research CE-EUS. The investigators will compare the research pre-operative contrast enhanced endoscopic ultrasounds images with already completed standard-of-care CT scans, the actual pancreatic involvement seen in surgery and the pathology reports.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Pilot Study of the Effects of Contrast Enhanced Endoscopic Ultrasound on Determining Vascular Involvement in Pancreatic Lesions|
- Lesion Margin [ Time Frame: Up to six months ] [ Designated as safety issue: No ]
- Sequence of filling [ Time Frame: Up to six months ] [ Designated as safety issue: No ]
- Pattern of Perfusion [ Time Frame: Up to six months ] [ Designated as safety issue: No ]
- Degree of venous washout [ Time Frame: Up to six months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Patients enrolled in the study will undergo contrast enhanced endoscopic ultrasound of the pancreas with Definity contrast after they have undergone their standard of care endoscopic ultrasound of the pancreas.
Drug: Definity Contrast
While the patient is still sedated from their EUS and before tissue sampling, the patient will receive a dose of Definity intravenously through their peripheral IV access after being agitated. The dose of Definity will be 10 microliters/kg given in one to two doses, and will not exceed 2cc.
Other Name: Definity ultrasound contrast
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01526590
|United States, Vermont|
|Fletcher Allen Healthcare||Not yet recruiting|
|Burlington, Vermont, United States, 05401|
|Contact: Paul Taheri 802-656-5040 email@example.com|
|Principal Investigator:||James Hebert, M.D.||University of Vermont/Fletcher Allen Healthcare|