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OpenTrials
Completed

NCT Number: NCT03525847

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

Completed

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Key information

Conditions

Endoscopic Ultrasonography

Age range

18 year–86 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seicean Andrada

Cluj-Napoca, Cluj, Romania

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endosonography

Diagnostic Test

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

Primary outcomes

  1. 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

    Time frame: 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 outcomes

  1. Quality of histological specimen(histology core) obtained with the two types of FNA biopsies (contrast enhanced and standard)

    Time frame: 5 days

    Visual analogic scale

  2. Dysfunction in the two types of biopsies

    Time frame: day one

    failure or difficulty reports with each procedure (%)

  3. Comparison between standand endosonography and contrast enhanced endosonography in obtaining a superior quality in obtaining histology core

    Time frame: day one

    Visual analogic scale

Sponsors and collaborators

Lead sponsor

Professor Dr. Seicean Andrada

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
May 16, 2018
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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