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

Per Hedenström

Status: Completed

Conditions: Neoplasms

Treatments: Device: EUS-guided fine needle biopsy sampling (EUS-FNB)

Study type: Interventional

Funder types: Other

Identifiers

NCT02360839

Dnr 1092-11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Referral for a diagnostic EUS

Exclusion criteria

• Referral for an interventional EUS

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,000 participants in 2 patient groups

Early

No Intervention group

Description:

Study subjects (patients) undergoing endoscopic ultrasound (with or without FNA/TCB) for clinical reasons during 2005-2011.

Late

Other group

Description:

Study subjects (patients) undergoing endoscopic ultrasound with EUS-guided sampling of various lesions for clinical reasons during 20012-2015. Subjects sampled with both EUS-FNA and EUS-FNB on the same lesion. Randomization on first needle order.

Treatment:

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