Conventional Versus Elastography Targeted Endoscopic Ultrasound Fine Needle Aspiration of Solid Pancreatic Lesions
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|ClinicalTrials.gov Identifier: NCT03210948|
Recruitment Status : Not yet recruiting
First Posted : July 7, 2017
Last Update Posted : November 27, 2018
Diagnostic assessment of solid pancreatic lesions may represent a real challenge in the clinical practice, even with the aid of tissue sampling by means of endoscopic ultrasound (EUS) fine needle aspiration (FNA).
Aim of this randomized controlled trial (RCT) is to establish the diagnostic accuracy, sensitivity, and specificity of real time elastography (RTE)-guided EUS-FNA as compared to conventional EUS-FNA in a series of patients with solid pancreatic masses.
Eligible will be patients with solid pancreatic masses detected at abdominal imaging (ultrasound, CT-scan or MRI).
In the treatment arm, RTE assessment of pancreatic masses will be performed using a last generation ultrasound machine, and all suspicious areas at elastography (i.e. those appearing in dark blue color as a consequence of higher cellularity of tumoral tissue) will be recorded and stored in our database. A 25 G needle will be then inserted into the most suspicious part ("dark blue") of the lesion and immediately after the procedure the stylet will be removed. At the end of the procedure, the needle will be retracted and the samples will be prepared for cytological examination.
Primary endpoint will be diagnostic yield of the procedure. Secondary endpoints the diagnostic sensitivity, specificity, number of passes needed to achieve an adequate sample and safety It will be planned to enroll 142 patients (71 per arms) within 1 year. A minimum follow up of 6 months from the last patient unsuitable to surgery will be required.
|Condition or disease||Intervention/treatment||Phase|
|Pancreas Cancer||Device: RTE-guided EUS-FNA Device: Conventional EUS-FNA||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||142 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Conventional Versus Elastography Targeted Endoscopic Ultrasound Fine Needle Aspiration of Solid Pancreatic Lesions: a Randomized Controlled Trial|
|Estimated Study Start Date :||January 23, 2019|
|Estimated Primary Completion Date :||February 20, 2019|
|Estimated Study Completion Date :||February 20, 2019|
Experimental: RTE-guided EUS-FNA
The needle will be then inserted into the most suspicious part ("dark blue") of the lesion as assessed at real time elastography.
Device: RTE-guided EUS-FNA
Fine needle aspiration with 25 gauge needle under RTE-guidance
Active Comparator: Conventional EUS-FNA
A 25 G needle with a central stylet to protect the aspiration channel of the needle will be introduced though the endoscope's working channel.
Device: Conventional EUS-FNA
Fine needle aspiration with no RTE guidance
- Diagnostic accuracy [ Time Frame: 12 months ]Proportion of correctly classified subjects (true positives+true negatives) among all subjects (true positives+true negatives+false positives+false negatives)
- Diagnostic sensitivity [ Time Frame: 12 months ]Proportion of subjects with the disease with positive test result in a total group of subjects with the disease
- Diagnostic specificity [ Time Frame: 12 months ]Proportion of subjects without the disease with negative test result in total of subjects without disease
- Number of passes needed to achieve an adequate sample [ Time Frame: 1 day ]Number of needle injections into the lesion needed to obtain an adequate and diagnostic sample
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 1 week ]Side effects
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210948
|Contact: Antonio Facciorusso, MD||+39 email@example.com|
|Contact: Nicola Muscatiello, MD||+39 firstname.lastname@example.org|
|Ospedali Riuniti Foggia|
|Foggia, Italy, 71122|
|Contact: Antonio Facciorusso, MD email@example.com|
|Study Director:||Antonio Facciorusso, MD||Ospedali Riuniti di Foggia|