Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT01526590 |
| Other study ID # |
CHRMS_M11-203 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
January 10, 2012 |
| Last updated |
June 3, 2015 |
| Start date |
July 2012 |
| Est. completion date |
July 2013 |
Study information
| Verified date |
June 2015 |
| Source |
University of Vermont |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Food and Drug Administration |
| Study type |
Interventional
|
Clinical Trial 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.
Description:
1. CT Scan of the abdomen - Standard Therapy
a. The standard of care is that patients in question of pancreatic lesions undergo CT
scanning. After a CT scan, if it appears that the pancreatic mass may be resectable,
the standard protocol is to look at the pancreas while the patient is sedated with
endoscopic ultrasound for diagnostic tissue sampling and further staging. For this
reason, the endoscopist will not be blinded to the CT scan because it is the standard
of care that they interpret the results of the EUS with that information.
2. Consent for Endoscopic Ultrasound (EUS) - Standard Therapy
a. Before being sedated and having endoscopic ultrasound, all patients are informed
about the risks of the procedure, alternatives, and what will be done. The patients who
decide to undergo endoscopic ultrasound will sign a consent form. Our goal is to enroll
30 patients (This number is limited by both the amount of contrast received from
Lantheus and the number of patients typically seen in a year. Ideally we will enroll as
many as possible for the purposes of power).
3. Consent for Contrast Enhanced Endoscopic Ultrasound (CE-EUS) -- Performed exclusively
for research purposes
1. After the patient has been informed about the standard of care and signed a
consent form, the patient will be asked if they wish to participate in an
experimental study. If the patient is interested, they will be questioned about
potential structural heart defects, congenital heart defects, recent worsening of
heart or lung conditions, pulmonary hypertension, potential pregnancy, attempts to
become pregnant, if they are nursing, or allergies to the contrast. If they report
any of these relative contraindications, we will exclude them from participating
in the study.
2. If they are free of all of those relative contraindications, they will be provided
information about the study (see included forms) and will be asked to sign a
consent form as well as a HIPAA authorization.
4. EUS - Standard of Care
1. At this point they will undergo an endoscopic ultrasound of the pancreas as per
standard protocol. They will have a peripheral IV started by the endoscopic
technician or nurse anesthetist. While the patient is being prepared, both
research questionnaires (EUS and CE-EUS) will be filled out ahead of time with the
exception of the findings, in order to reduce the time to complete the survey. The
patient will be sedated in one of two ways. Either they will be consciously
sedated with meperidine and midazolam under the surveillance of the attending
gastroenterologist or they will have propofol based sedation under the
surveillance of an anesthesiologist as per standard endoscopic ultrasound
protocol.
2. The patient will undergo their endoscopic ultrasound and video and images will be
recorded.
5. EUS Questionnaire - Preformed exclusively for research purposes. Duration less than one
minute.
1. The endoscopist will then fill out a survey (see attached) to record their
impressions of the tumor and the extent of its invasion into the vasculature. This
should not take more than one minute. EUS criteria for vascular invasion will be
loss of normal hyperechoic interface between the tumor and the vessel, irregular
tumor and vessel interface, tumor within vessel lumen, vessel encasement, or
collaterals with venous occlusion.
6. Decision about FNA - Standard of care, but important that it is done before CU-EUS a.
If the endoscopist feels that FNA is warranted they will make the decision at this
time.
7. CE-EUS - Experimental Procedure performed exclusively for research purposes
a. Dosing of Contrast - procedure performed exclusively for research purposes i. While
the patient is still sedated and before tissue sampling, the experimental aspect of the
procedure will begin. At this time, they 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. A saline flush
will follow the injection of the contrast and a timer will be started. The remaining
contrast will be properly disposed of in a sharps container.
b. Recording of CE-EUS images - procedure performed exclusively for research purposes.
Duration 3-4 minutes i. The endoscopist will perform an additional reading with the
contrast and record a 3-4 minute segment for review later using the harmonic mode of
the ultrasound probe at a mechanical index of 0.3. The mechanical index may need to be
be optimized, however a previous study found 0.3 to be optimal. Aspects that will be
analyzed later are sequence of filling (central vs peripheral), timing (arterial
[0-30s], venous [60-180s], post-venous/equilibrium phase [>180s]), pattern of perfusion
(homogenous vs heterogenous, and with or without defect) and degree of venous washout.
After the experimental portion of the procedure the endoscopist will fill out a form
(see attached) to record their impressions of the characteristics of the tumor with
contrast. The images will be saved for further comparison with the CT scan and the
pathology results at a later time.
8. FNA - Standard of care (if previously decided upon)
a. If it was determined after the normal EUS but before the CE-EUS that the patient
needed tissue sampling, the patient will then undergo the sampling in the standard
fashion. If the patient was not to receive tissue sampling, the exam would be over.
When the exam is finished the endoscopist will fill out the remaining questionnaire
while the patient recovers.
9. Patient recovery in Endoscopy Suite - Standard of Care
10. Patient transport to recovery room - Standard of Care
1. After the patient recovers in the endoscopy room, the patient will be transported
to the recovery room where they will be monitored for at least 30 minutes. The
patient will be informed of the findings of their EUS per standard care. The
patient will not be informed of the findings of CE-EUS as the significance is
unknown.
2. If an incidental lesion is found on EUS then the patient will undergo the
appropriate follow-up for that lesion as per standard protocol. If an incidental
finding is not apparent on EUS or CT, but happens to show up with the CU-EUS, the
patient will be informed of the finding and its unknown significance.
11. Radiologist's Interpretation - Research purposes only
a. After CE-EUS and EUS, the images will be randomly ordered and interpreted by a
radiologist. An excel sheet will be made and the studies will be placed into three
separate blocks in chronological order Participant 1-10, 11-20, and 21-30. In a
separate column a random number generator will order the first block of 1-10's EUS into
a random order for and then again a different random order for CE-EUS. The radiologist
will fill out the attached questionnaire. The Surgeon will be blinded to these readings
as they are for research purposes only and not the standard of care.
12. Surgery - Standard of Care with questionnaire after the procedure for research purposes
a. The surgeon will record their impressions of the vascular involvement of the tumor
on the attached questionnaire after the surgery.
13. Pathology review - Standard of care a. If the patient has pathology sent from surgery,
the surgeon will label the vessels encompassed and the pathologist will report whether
there was invasion into the vasculature. We will retrospectively review the pathology
results of the surgery for comparison.
