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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03525847

Enrollment

150

Registered

2018-05-16

Start date

2017-01-01

Completion date

2020-01-01

Last updated

2022-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopic Ultrasonography

Keywords

Contrast endosonograpy

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

Interventions

DIAGNOSTIC_TESTEndosonography

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 86 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
Dysfunction in the two types of biopsies	day one	failure or difficulty reports with each procedure (%)

Countries

Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026