EUS vs. MDCT in Pancreatic Malignancy

NCT ID: NCT02115022

Last Updated: 2020-04-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2018-02-28

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).

Conditions

Resectable Pancreatic Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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..

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Medicine and Pharmacy Craiova

OTHER

Sponsor Role: collaborator

Iuliu Hatieganu University of Medicine and Pharmacy

OTHER

Sponsor Role: collaborator

Institutul Clinic Fundeni

OTHER

Sponsor Role: collaborator

Clinical Hospital Colentina

OTHER

Sponsor Role: lead

Responsible Party

Mihai Rimbas

MD, PhD, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mihai Rimbas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Hospital Colentina, Carol Davila University of Medicine and Pharmacy

Cristian R Baicus, Professor

Role: STUDY_CHAIR

Clinical Hospital Colentina, Carol Davila University of Medicine and Pharmacy

Adrian Saftoiu, Professor

Role: STUDY_DIRECTOR

Craiova research Center in Gastroenterology and Hepatology, Craiova University of Medicine and Pharmacy

Locations

Research Center in Gastroenterogy and Hepatology

Craiova, Dolj, Romania

University Military Hospital

Bucharest, , Romania

Gastroenterology Department, Clinical Hospital Colentina

Bucharest, , Romania

Fundeni Clinical Institute

Bucharest, , Romania

Iuliu Hatieganu University of Medicine

Cluj-Napoca, , Romania

Countries

Romania

Other Identifiers

Col-gastro 5

Identifier Type: -

Identifier Source: org_study_id