EUS vs. MDCT in Pancreatic Malignancy (EUSPACT)
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|ClinicalTrials.gov Identifier: NCT02115022|
Recruitment Status : Completed
First Posted : April 15, 2014
Last Update Posted : February 7, 2018
Accurate staging of patients with pancreatic cancer is critical to avoid the expense, morbidity, and mortality related to unnecessary surgery. While several tests are available for assessing such patients, consensus has not been achieved on the optimal approach. As a matter of fact, pancreatic cancer staging is discussed controversially due to conflicting evidence and certainly EUS has lost grounds due to improvements in CT technology. Thus, the role of EUS and EUS-guided FNA varies among treatment centers.
The present study is designed to better define the role of EUS in predicting resectability, as compared to high resolution cross-sectional imaging.
|Condition or disease|
|Resectable Pancreatic Cancer|
- HIGH-RESOLUTION PANCREATIC PROTOCOL COMPUTED TOMOGRAPHY (CT) SCAN EXAMINATION: performed on at least 16-section multi-detector row (MD) CT and reviewed using multi-planar reconstructions, with images obtained following the oral administration of water and pancreatic protocol intravenous iopamidol, with images acquired in the pancreatic and portal venous phases of contrast enhancement, reconstructed as thin slice (at 1 mm - pancreatic phase or 2 mm - portal venous phase increments).
- EUS EXAMINATION: performed within 2 weeks of the MDCT, aiming visualization of the pancreas, main surrounding vascular structures, celiac and mediastinal lymph nodes, liver and left adrenal gland, with EUS-FNA performed at the discretion of the investigator/examiner to confirm/exclude metastases and for the confirmation of malignancy in the primary tumor. Patients confirmed by EUS as having distant metastases are to be deferred from the planned surgical intervention.
- SURGICAL INTERVENTION: aiming to provide curative intent (R0) resection.
- HISTOPATHOLOGICAL POSTOPERATIVE STAGING: with evaluation of loco-regional invasiveness and degree of complete surgical resection (R0/R1).
- FOLLOW-UP OF PATIENTS: with phone-calls on an every 6 month basis, for up to 2 years, retaining the following data: survival (or not), date of decease and its direct cause (if applicable), the presence of tumor recurrence (or not).
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||45 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Endoscopic UltraSound in Potentially Resectable PAncreatic Malignancy - Does it Bear the Weight of the Rapidly Evolving Technology of Computer Tomography?|
|Actual Study Start Date :||July 2014|
|Actual Primary Completion Date :||January 2018|
|Actual Study Completion Date :||February 2018|
Potentially resectable pancreatic cancer
Patients with a confirmed pancreatic mass (suspected neoplastic) deemed resectable or borderline resectable on multislice (at least 16 simultaneously acquired slices) pancreatic protocol computed tomography (CT), fit and willing to undergo surgery with a curative (R0) intent.
- Staging capability of each study procedure [ Time Frame: Up to 2 weeks, depending on the time of the surgical intervention ]Each imaging test (MDCT and EUS) and findings at or after surgery are to be judged on their ability to provide descriptions of the primary tumor's size, location, relationship to vessels - using the terms abutment (≤180º of contact) and encasement (>180º of contact), vessel occlusion, variant vascular anatomy, a grade regarding local tumor resectability (resectable, borderline resectable, or locally advanced; R0 or R1 resection), and extent and location of extrapancreatic disease.
- Side-effects related to the EUS examination [ Time Frame: Monitored for 24 hours after EUS ]Each patient will be monitored for 24 hours after the EUS examination to identify possible early complications of the procedure
- Patient survival time, and tumor recurrence-free survival [ Time Frame: Up to 2 years ]Each patient is going to be followed-up for up to 2 years after the surgical intervention an an every-6 month basis, in order to identify events such as death or tumor recurrence.
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): NCT02115022
|Research Center in Gastroenterogy and Hepatology|
|Craiova, Dolj, Romania, 200638|
|University Military Hospital|
|Bucharest, Romania, 010825|
|Gastroenterology Department, Clinical Hospital Colentina|
|Bucharest, Romania, 020125|
|Fundeni Clinical Institute|
|Iuliu Hatieganu University of Medicine|
|Cluj Napoca, Romania|
|Principal Investigator:||Mihai Rimbas, MD, PhD||Clinical Hospital Colentina, Carol Davila University of Medicine and Pharmacy|
|Study Chair:||Cristian R Baicus, Professor||Clinical Hospital Colentina, Carol Davila University of Medicine and Pharmacy|
|Study Director:||Adrian Saftoiu, Professor||Craiova research Center in Gastroenterology and Hepatology, Craiova University of Medicine and Pharmacy|