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

Not Applicable

Completed

• Conditions: Endoscopic Ultrasonography
• Interventions: Diagnostic Test: Endosonography

• Registration Number: NCT03525847
• Lead Sponsor: Professor Dr. Seicean Andrada

Brief Summary

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

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 Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-11-16
• Study First Submitted QC: 2018-05-14
• Study First Posted: 2018-05-16
• Primary Completion: 2019-01-01
• Study Completion: 2020-01-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
contrast enhanced FNA endosonography	Endosonography	First passage in the solid pancreatic tumor using FNA endosonography then with the contrast enhanced FNA endosonography
FNA standard endosonography	Endosonography	First passage in the solid pancreatic tumor using contrast enhanced FNA endosonography then with the FNA endosonography

Primary Outcome Measures

Name	Time	Method
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	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seicean Andrada; 🇷🇴 Cluj-napoca, Cluj, Romania