- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2014-07
2018-01
2018-02
45
NCT02115022
Clinical Hospital Colentina
Clinical Hospital Colentina
OBSERVATIONAL
EUS vs. MDCT in Pancreatic Malignancy
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.
Registry procedures: * 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).
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2014-04-13 | N/A | 2020-04-26 |
2014-04-13 | N/A | 2020-04-28 |
2014-04-15 | N/A | 2020-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : 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 |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Staging capability of each study procedure | 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. | Up to 2 weeks, depending on the time of the surgical intervention |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Side-effects related to the EUS examination | Each patient will be monitored for 24 hours after the EUS examination to identify possible early complications of the procedure | Monitored for 24 hours after EUS |
| Patient survival time, and tumor recurrence-free survival | 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. | Up to 2 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
