Contrast Enhanced Endoscopic Ultrasound for Vascular Involvement in Pancreatic Lesions
Status:
Withdrawn
Trial end date:
2013-07-01
Target enrollment:
Participant gender:
Summary
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.