Clinical trial NCT02115022: EUS vs. MDCT in Pancreatic Malignancy
Official title: Endoscopic UltraSound in Potentially Resectable PAncreatic Malignancy - Does it Bear the Weight of the Rapidly Evolving Technology of Computer Tomography?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Resectable Pancreatic Cancer
Keywords: pancreatic cancer
resectability
endosonography (EUS)
multidetection computer tomography (MDCT)
staging
Lead sponsor: Clinical Hospital Colentina
Sponsor class: OTHER
Collaborators: name: University of Medicine and Pharmacy Craiova
name: Iuliu Hatieganu University of Medicine and Pharmacy
name: Institutul Clinic Fundeni
First posted: 2014-04-15
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive 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.

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* adult (≥ 18 years of age) patients;
* the presence of a confirmed pancreatic mass (suspected neoplastic) deemed resectable or borderline resectable on multislice (at least 16 simultaneously acquired slices) pancreatic protocol computed tomography (CT);
* patients fit and willing to undergo surgery with a curative (R0) intent;
* sign of the informed consent.

Exclusion Criteria:

* the presence of significant co-morbidities that contraindicate pancreatic resection;
* previous neo-adjuvant oncologic therapy;
* distant metastases;
* lack of discernment;
* refusal to sign the informed consent..

Primary outcomes:
measure: Staging capability of each study procedure
timeFrame: Up to 2 weeks, depending on the time of the surgical intervention
Secondary outcomes:
measure: Side-effects related to the EUS examination
timeFrame: Monitored for 24 hours after EUS
measure: Patient survival time, and tumor recurrence-free survival
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Craiova
country: Romania
facility: Research Center in Gastroenterogy and Hepatology
state: Dolj
city: Bucharest
country: Romania
facility: University Military Hospital
city: Bucharest
country: Romania
facility: Gastroenterology Department, Clinical Hospital Colentina
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
city: Cluj Napoca
country: Romania
facility: Iuliu Hatieganu University of Medicine
Study officials:
affiliation: Clinical Hospital Colentina, Carol Davila University of Medicine and Pharmacy
name: Mihai Rimbas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Hospital Colentina, Carol Davila University of Medicine and Pharmacy
name: Cristian R Baicus, Professor
role: STUDY_CHAIR
affiliation: Craiova research Center in Gastroenterology and Hepatology, Craiova University of Medicine and Pharmacy
name: Adrian Saftoiu, Professor
role: STUDY_DIRECTOR
References: