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

Neoplasms Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Neoplasms

• NCT number: NCT02360839
• Study type: Interventional
• Source: Sahlgrenska University Hospital, Sweden
• Status: Completed
• Phase: N/A
• Start date: July 2009
• Completion date: December 31, 2022