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Completed

NCT Number: NCT04002778

Rapid On-Site Evaluation (ROSE) by Endosonographer: for Whom, When and by Whom?

Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a highly sensitive and specific method in diagnosing solid pancreatic lesions. Rapid on-site evaluation (ROSE) of the aspirate by a cytopathologist improves specimen adequacy and diagnostic accuracy while reducing the number of needle passes. As this increases costs and implicates availability issues, the investigators aimed to evaluate the utility of ROSE by the endosonographer in guiding EUS-FNA of solid pancreatic lesions.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Consecutive patients with a solid pancreatic lesion were included. Endosonographer was submitted to a basic pancreatic cythpatology training programme at two institutitions. The patients were randomly allocated to the ROSE group - in which the number of needle passes required to obtain a sample suitable for cytopathologic categorization was established by the endosonographer's on-site evaluation - or to the non-ROSE group - in whom adequacy of the specimen was evaluated macroscopically and up to five needle passes could be performed, assuring sample adequacy. The gold standard was the final cytopathologist's diagnosis. The number of needle passes, procedure duration, specimen adequacy, diagnostic yield and adverse events rates were compared between groups and the performance measures of ROSE by endosonographer were determined.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • solid pancreatic lesions detected by trans abdominal ultrasound or cross-sectional image (CT or MRI).
  • formal indications to undergo EUS-FNA which were: differentiation between benign and malignant diseases, radiologic criteria of inoperability or unresectability, need for specific diagnosis which could modify therapeutic strategy and need for a diagnosis before neoadjuvant therapy.

Exclusion criteria

  • a cystic or solid cystic aspect of the pancreatic lesion on above mentioned image methods
  • lesions previously punctured on past EUS-FNA procedures
  • American Society of Anesthesiologist (ASA) Physical Status Classification System IV or V
  • cases of surveillance of solid pancreatic lesions
  • severe coagulation disorder (platelet count < 50000 or International Normalized Ratio > 2,0)
  • impossibility of previous suspension of antiplatelet agents (except acetylsalicylic acid) or anticoagulants (all)
  • patient unwillingness to participate

Treatment and study plan

fine needle aspiration

Diagnostic Test

Rapid on-site evaluation

Diagnostic Test

Primary outcomes

  1. Procedure duration

    Time frame: Procedure

    Minutes

Secondary outcomes

  1. Specimen adequacy rate

    Time frame: Through study completion, an average of 18 months

    Cases with a sample suitable for a definitive diagnosis over the total number of cases

  2. Total number of passes

    Time frame: Through study completion, an average of 18 months

    total number of passes of all procedures

  3. Number of adverse events

    Time frame: Through study completion, an average of 18 months

    Total number of adverse events of all procedures

  4. Diagnostic yield

    Time frame: Through study completion, an average of 18 months

    Cases in which a final diagnostic could be established over the total number of cases

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 1, 2019
Registry last updated
Jul 1, 2019

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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