The Added Value of Contrast Enhancement for Guiding EUS-FNA in Solid Pancreatic Masses

A prospective study designed to show the superiority of contrast guided echoendoscopy versus conventional echoendoscopy

Study Overview

• Status: Completed
• Conditions: Endoscopic Ultrasonography
• Intervention / Treatment: Diagnostic test: Endosonography

Detailed Description

A prospective study that compares the results using FNA contrast echoendoscopy versus standard FNA echoendoscopy in the diagnosis of solid pancreatic tumors

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Cluj
    • Cluj-napoca, Cluj, Romania
      • Seicean Andrada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 86 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• solid pancreatic tumor lesions

Exclusion Criteria:

• severe coagulopathy of trombocytopenia <50.000
• patients refuse for biopsy prelevation or pacient's refuse to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: contrast enhanced FNA endosonography; First passage in the solid pancreatic tumor using FNA endosonography then with the contrast enhanced FNA endosonography	Diagnostic test: Endosonography; Puncture of the pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control. Passage in the same pancreatic mass of first using standard FNA method then contrast enhanced FNA method or vice versa according to the randomization
ACTIVE_COMPARATOR: FNA standard endosonography; First passage in the solid pancreatic tumor using contrast enhanced FNA endosonography then with the FNA endosonography	Diagnostic test: Endosonography; Puncture of the pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control. Passage in the same pancreatic mass of first using standard FNA method then contrast enhanced FNA method or vice versa according to the randomization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of CEUS FNA endosonography versus standard FNA endosonography in the etiological cyto histological of pancreatic solid tumors using histology core as comparison between the two methods	Diagnostic accuracy of CEUS FNA endosonography versus standard FNA endosonography in the etiological cyto histological of pancreatic solid tumors using histology core as comparison between the two methods	an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of histological specimen(histology core) obtained with the two types of FNA biopsies (contrast enhanced and standard)	Visual analogic scale	5 days
Dysfunction in the two types of biopsies	failure or difficulty reports with each procedure (%)	day one
Comparison between standand endosonography and contrast enhanced endosonography in obtaining a superior quality in obtaining histology core	Visual analogic scale	day one

Collaborators and Investigators

• Sponsor: Professor Dr. Seicean Andrada
• Investigators: Principal Investigator: Seicean Andrada, Regional Institute of Gastroenterology and Hepatology "Octavian Fodor"Cluj-Napoca

Publications and helpful links

General Publications

• Hou X, Jin Z, Xu C, Zhang M, Zhu J, Jiang F, Li Z. Contrast-enhanced harmonic endoscopic ultrasound-guided fine-needle aspiration in the diagnosis of solid pancreatic lesions: a retrospective study. PLoS One. 2015 Mar 20;10(3):e0121236. doi: 10.1371/journal.pone.0121236. eCollection 2015.
• Yoshinaga S, Suzuki H, Oda I, Saito Y. Role of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for diagnosis of solid pancreatic masses. Dig Endosc. 2011 May;23 Suppl 1:29-33. doi: 10.1111/j.1443-1661.2011.01112.x.
• Seicean A, Jinga M. Harmonic contrast-enhanced endoscopic ultrasound fine-needle aspiration: Fact or fiction? Endosc Ultrasound. 2017 Jan-Feb;6(1):31-36. doi: 10.4103/2303-9027.196917.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): January 1, 2019
• Study Completion (ACTUAL): January 1, 2020

Study Registration Dates

• First Submitted: November 16, 2017
• First Submitted That Met QC Criteria: May 14, 2018
• First Posted (ACTUAL): May 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Contrast endosonograpy
• Other Study ID Numbers: 10430

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The Study is used to show the superiority of CEUS-FNA endosonography Versus standard FNA endosonography in diagnosis of solid pancreatic masses

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No