EUSPACT: EUS vs. MDCT in Pancreatic Malignancy

Sponsor

Clinical Hospital Colentina (Other)

Overall Status

Completed

CT.gov ID

NCT02115022

Collaborator

University of Medicine and Pharmacy Craiova (Other), Iuliu Hatieganu University of Medicine and Pharmacy (Other), Institutul Clinic Fundeni (Other)

Enrollment

Locations

43.1

Actual Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Resectable Pancreatic Cancer

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

45 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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 :

Jul 1, 2014

Actual Primary Completion Date :

Jan 1, 2018

Actual Study Completion Date :

Feb 1, 2018

Arms and Interventions

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 curative (R0) intent.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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..

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Center in Gastroenterogy and Hepatology	Craiova	Dolj	Romania	200638
2	University Military Hospital	Bucharest		Romania	010825
3	Gastroenterology Department, Clinical Hospital Colentina	Bucharest		Romania	020125
4	Fundeni Clinical Institute	Bucharest		Romania
5	Iuliu Hatieganu University of Medicine	Cluj Napoca		Romania

Sponsors and Collaborators

Clinical Hospital Colentina
University of Medicine and Pharmacy Craiova
Iuliu Hatieganu University of Medicine and Pharmacy
Institutul Clinic Fundeni

Investigators

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