Skip to main content
OpenTrials
Completed

NCT Number: NCT02115022

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Resectable Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Center in Gastroenterogy and Hepatology, Craiova, Dolj, Romania

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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..

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Clinical Hospital Colentina

Other

Collaborators

  • Institutul Clinic Fundeni
  • Iuliu Hatieganu University of Medicine and Pharmacy
  • University of Medicine and Pharmacy Craiova

Registry information

Official study title

Endoscopic UltraSound in Potentially Resectable PAncreatic Malignancy - Does it Bear the Weight of the Rapidly Evolving Technology of Computer Tomography?

Acronym: EUSPACT

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Apr 15, 2014
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.