200
Participants
Start Date
May 1, 2018
Primary Completion Date
February 28, 2023
Study Completion Date
February 28, 2023
Endoscopic ultrasound (including fine needle aspiration)
"EUS will be performed before (including EUS-FNA for confirmation of diagnosis) and 2 months after the first course of treatment.~* Protocol of EUS with EUS-FNA should include linear EUS instruments with complete examinations of the pancreas.~* Tumor characteristics (echogenicity, echostructure, size) will be described as well as presence/absence of power Doppler signals.~* EUS-FNA will be performed in all pancreatic masses with at least four passes."
Contrast-enhanced endoscopic ultrasound (CE-EUS)
"CE-EUS will be performed during usual EUS examination before and 2 months after the first course of chemotherapy.~* The starting point of the timer will be considered the moment of intravenous contrast injection (Sonovue 4.8 mL).~* The whole movie (T0-T120s) will be recorded in a DICOM format on the embedded HDD of the ultrasound system, for later analysis.~* All post-processing and computer analysis of digital movies will be performed within the coordinating IT Center using Vue-Box"
Endoscopic ultrasound elastography (EG-EUS)
"EUS-EG will be performed during usual EUS examinations, before and 2-months after the first course of chemotherapy, with two movies of 10 seconds recorded on the embedded HDD~* The region of interest for EUS-EG will be preferably larger than the focal mass. If the focal mass is larger than 3 cm, part of the mass will be included in the ROI, as well as the surrounding structures. Very large ROI for the elastography calculations will be avoided~* The following pre-settings will be used in all centers: elastography color map 1, frame rejection 2, noise rejection 2, persistence 3, dynamic rage 4, smoothing 2, blend 50%.~* SR and SH will be measured; with three measurements made and recorded on the embedded HDD."
Contrast-enhanced computed tomography (CT)
"* Contrast-enhanced computed tomography will be obtained before treatment to assess the local extension of the tumor, and presence of lymph nodes and distant metastases.~* A template will be used to report the imaging results.~* The template includes morphologic, arterial, venous, and extrapancreatic evaluations.~* Contrast-enhanced computed tomography will be performed 2 months after the first course of chemotherapy, using the same template, in order to evaluate the tumor response. Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST)."
Collaborators (1)
Copenhagen University Hospital at Herlev
OTHER
Iuliu Hatieganu University of Medicine and Pharmacy
OTHER
Central Military Hospital Bucharest
UNKNOWN
Ponderas Regina Maria Hospital Bucharest
UNKNOWN
Caritas-Krankenhaus Bad Mergentheim
OTHER
Helios Kliniken Meiningen
UNKNOWN
University of Santiago de Compostela
OTHER
Hospital Märkisch Oderland Wriezen/ Strausberg
UNKNOWN
Institut Paoli-Calmettes
OTHER
Ospedale San Raffaele
OTHER
University College London Hospitals
OTHER
Newcastle-upon-Tyne Hospitals NHS Trust
OTHER
M.D. Anderson Cancer Center
OTHER
Shengjing Hospital
OTHER
Asan Medical Center
OTHER
Tokyo Medical University
OTHER
Singapore General Hospital
OTHER
University of Medicine and Pharmacy Craiova
OTHER