EUS vs. MDCT in Pancreatic Malignancy

Completed

• Conditions: Resectable Pancreatic Cancer

• Registration Number: NCT02115022
• Lead Sponsor: Clinical Hospital Colentina

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).

Study Timeline

• Study First Submitted: 2014-04-13
• Study First Submitted QC: 2014-04-13
• Study First Posted: 2014-04-15
• Study Start: 2014-07
• Primary Completion: 2018-01
• Study Completion: 2018-02
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-26
• Last Update Posted: 2020-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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..

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Staging capability of each study procedure	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.

Secondary Outcome Measures

Name	Time	Method
Side-effects related to the EUS examination	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	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.

Trial Locations

Locations (5)

Gastroenterology Department, Clinical Hospital Colentina; 🇷🇴 Bucharest, Romania

Iuliu Hatieganu University of Medicine; 🇷🇴 Cluj Napoca, Romania

University Military Hospital; 🇷🇴 Bucharest, Romania

Research Center in Gastroenterogy and Hepatology; 🇷🇴 Craiova, Dolj, Romania

Fundeni Clinical Institute; 🇷🇴 Bucharest, Romania