Skip to main content
OpenTrials
Completed

NCT Number: NCT02360839

The Use of FNA and FNB in the Optimization of EUS-assisted Tissue Sampling

Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) for cytology and/or fine needle biopsy (FNB) for histology may be used in the diagnostic work-up of intrathoracic and intrabdominal lesion of unknown origin. Certain lesions (such as pancreatic adenocarcinoma) are often well characterized by cytology assessment of FNA-samples while others are not (such as GIST-tumors).

This study is a part observational (early study phase) and part interventional study (late study phase) on the diagnostic accuracy of EUS-assisted tissue sampling by FNA or FNB during a 10-year period on a tertiary endoscopy centre.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr Per Hedenström

Gothenburg, S-413 45, Sweden

About this study

Variables affecting the diagnostic accuracy of EUS-FNA and EUS-FNB in different cases and tumor scenarios will be studied in detail such as the influence of medical equipment used (i.e the different types and sizes of puncture needles), the experience of the endosonographers, cytopathologists and pathologists and the use of rapid on-site evaluation of cytology samples.

Each study case is reviewed post-EUS (according to the schedule precised below) regarding further diagnostic work-up, neoadjuvant treatment, surgery result, clinical follow-up, (neo)adjuvant treatment, and survival. Non-parametrical tests will be applied as the main statistical method.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Referral for a diagnostic EUS

Exclusion criteria

  • Referral for an interventional EUS

Treatment and study plan

EUS-guided fine needle biopsy sampling (EUS-FNB)

Device

Dual sampling with EUS-FNA and EUS-FNB in a randomized order.

Primary outcomes

  1. The cellular quality of the EUS-FNA specimens (categorical variable).

    Time frame: Follow up is by time of surgery (in average 2 months after EUS-FNA)

    Specimens are measured on a standardized 5-grade categorical scale - from 1 (=poor, non-diagnostic yield) to 5 (excellent, completely diagnostic yield). There is no specific unit measured (the variable is not a continuous one). The results from cytology assessment of EUS-derived tissue are compared to the final diagnosis, that is based on the subsequent surgery report. Results from FNA and FNB are regarded equally important. That is why both are treated as Primary Outcomes.

  2. The histological quality of the EUS-FNB specimens (categorical variable).

    Time frame: Follow up is by time of surgery (in average 2 months after EUS-FNB)

    Specimens are measured on a standardized 5-grade categorical scale - from 1 (=poor, non-diagnostic yield) to 5 (excellent, completely diagnostic yield). There is no specific unit measured (the variable is not a continuous one). The results from pathology assessment of EUS-derived tissue are compared to the final diagnosis, that is based on the subsequent surgery report. Results from FNA and FNB are regarded equally important. That is why both are treated as Primary Outcomes.

Secondary outcomes

  1. Immunohistochemistry profiling of EUS

    Time frame: Follow up is by time of surgery (in average 2 months after EUS)

    The immunohistochemical (IHC) profile of tumor material from EUS-samples will be compared to the immunohistochemical profile of tissue derived from surgery of the very same case (categorical variable, Yes (1) = correct IHC-profiling by EUS or No (2) = non-correct IHC-profiling by EUS).

Sponsors and collaborators

Lead sponsor

Per Hedenström

Other

Registry information

Important dates

Study start
2009
Primary completion
2022
Study completion
2022
First posted
Feb 11, 2015
Registry last updated
Jun 28, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.