The purpose of this study is to characterize the contrast enhancement patterns on EUS of different solid lesions in the pancreas, and to determine the correlations of these contrast-enhanced EUS findings with the histological gold standard obtained…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Descriptions of the contrast-enhanced vascular perfusion patterns of solid
pancreatic mass lesions, and the correlations to the histological diagnoses
obtained from FNA or subsequent surgery. This will enable derivation of the
sensitivity, specificity, positive predictive value and negative predictive
value of each contrast harmonic EUS image pattern for the different solid
lesions in the pancreas.
Secondary outcome
n/a
Background summary
Endoscopic ultrasound (EUS) is the best imaging modality for characterizing
focal lesions within the pancreas. However, differentiating between solid
pancreatic lesions by EUS imaging alone can be challenging. Currently,
exclusion of malignant disease requires histology from a fine needle aspiration
of the lesion, but this too is not always entirely definitive.
Contrast-enhanced harmonic EUS is a new technology that offers the potential
for improved diagnostic capabilities, and may help to more reliably
discriminate between benign and malignant lesions.
Study objective
The purpose of this study is to characterize the contrast enhancement patterns
on EUS of different solid lesions in the pancreas, and to determine the
correlations of these contrast-enhanced EUS findings with the histological gold
standard obtained by fine needle aspiration or subsequent surgery.
Study design
Prospective, observational cohort study.
Study burden and risks
Participation in the study only involves receiving the contrast agent Sonovue
with additional imaging with special ultrasound software during an already
scheduled EUS procedure. Thus, no additional procedures or interventions other
than the administration of a commercially available, non-experimental contrast
agent are required. The alternative for patients who decline is to simply
undergo conventional EUS without contrast enhancement followed by EUS-guided
FNA. No follow-up visits or additional tests are required of study participants
unless dictated by ongoing clinical care, which is separate from the study. The
risk of study participation is the rare possibility of an allergic-type
reaction to Sonovue. The immediate benefit of study participation is expected
improved visualization of the pancreatic mass lesion. The greater benefit from
the study is the hope for improved diagnostic capabilities with EUS that may in
future enable better differentiation of lesions in the pancreas and may
ultimately obviate the need for tissue sampling in some patients.
's Gravendijkswal 230
2993 CG
NL
's Gravendijkswal 230
2993 CG
NL
Listed location countries
Age
Inclusion criteria
1) Adult patient 18 years or older.
2) Able to read & write in Dutch.
3) Undergoing EUS for the evaluation of a solid pancreatic lesion.
Exclusion criteria
1) Cystic pancreatic lesion.
2) Known allergy to Sonovue (contrast agent).
3) Unstable ischemic heart disease (contra-indication to Sonovue).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30457.078.09 |