EUS vs. MDCT in Pancreatic Malignancy

NCT02115022 | Completed

• 1 other identifier: Col-gastro 5
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 5

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.

Conditions

Resectable Pancreatic Cancer

Keywords

pancreatic cancer; resectability; endosonography (EUS); multidetection computer tomography (MDCT); staging

Outcome Measures

Primary Outcomes (1)

• Staging capability of each study procedure

  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.

  Up to 2 weeks, depending on the time of the surgical intervention

Secondary Outcomes (2)

• Side-effects related to the EUS examination

  Monitored for 24 hours after EUS

• Patient survival time, and tumor recurrence-free survival

  Up to 2 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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..

Sponsors & Collaborators

• Clinical Hospital Colentina: lead
• University of Medicine and Pharmacy Craiova: collaborator
• Iuliu Hatieganu University of Medicine and Pharmacy: collaborator
• Institutul Clinic Fundeni: collaborator

Study Sites (5)

Research Center in Gastroenterogy and Hepatology

Craiova, Dolj, 200638, Romania

Location

University Military Hospital

Bucharest, 010825, Romania

Location

Gastroenterology Department, Clinical Hospital Colentina

Bucharest, 020125, Romania

Location

Fundeni Clinical Institute

Bucharest, Romania

Location

Iuliu Hatieganu University of Medicine

Cluj-Napoca, Romania

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Mihai Rimbas, MD, PhD

  Clinical Hospital Colentina, Carol Davila University of Medicine and Pharmacy

  PRINCIPAL INVESTIGATOR

• Cristian R Baicus, Professor

  Clinical Hospital Colentina, Carol Davila University of Medicine and Pharmacy

  STUDY CHAIR

• Adrian Saftoiu, Professor

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Assistant Professor

Study Record Dates

• First Submitted: April 13, 2014
• First Posted: April 15, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: February 1, 2018
• Last Updated: April 28, 2020

Record last verified: 2020-04

Locations

RO (5)