NCT05825729

Diagnostic Efficacy Of 3 EUS-FNB Techniques

Status unknown Phase 4 Last updated 15 November 2023

What this trial tests

Phase 4 trial testing Dry suction technique (A) in Efficacy, Self in 330 participants. Status unknown.

Timeline

27 June 2023

Primary endpoint
22 May 2025

22 May 2025

Quick facts

Lead sponsor	Hospital Universitario Insular Gran Canaria
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	diagnostic
Enrollment	330
Start date	27 June 2023
Primary completion	22 May 2025
Estimated completion	22 May 2025
Sites	2 locations across Spain

Drugs / interventions tested

• Dry suction technique (A)
• Slow-pull technique (B)
• Wet suction technique (C)

Conditions studied

• Efficacy, Self — all drugs for Efficacy, Self →

Sponsor

Hospital Universitario Insular Gran Canaria

Who can join

18 and older, any sex, with Efficacy, Self. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Endoscopic ultrasound (EUS) is a widely recognized tool for over 30 years for diagnosing intra-abdominal lesions and gastrointestinal cancers, especially pancreatic neoplasia. In most hospitals, it is the preferred method for sampling using fine-needle aspiration (EUS-FNA) or histology needle aspiration biopsy (EUS-FNB) to obtain cytological and histological material for an anatomopathological diagnosis. It is also recognized by current oncology guidelines.

Numerous factors can affect the efficacy of this technique, such as the needle size, type (cytology or histology), number of passes made on the lesion, the presence or absence of a pathologist in the endoscopy room, the experience of the endoscopist, etc.

Currently, EUS-FNA or EUS-FNB are recommended interchangeably for diagnosis; however, it appears that histology needles (EUS-FNB) allow for greater diagnostic efficacy by obtaining a cellular block with fewer passes, which allows for more advanced anatomopathological analysis (such as immunohistochemistry or molecular analysis).

Regarding the technique for performing the puncture and acquiring the sample, current European guidelines recommend sampling using EUS-FNA or FNB by dry suction with a 10 mL syringe. However, other recognized techniques, such as using a stylet with the "slow-pull" technique (not positioning for or against) or liquid biopsy (which could obtain larger cellular blocks compared to dry puncture), are widely used and could obtain better samples, but there is no clear consensus currently.

Investigators' goal is to conduct a randomized clinical trial of three EUS-FNB techniques (dry puncture vs slow-pull vs wet puncture) used in daily clinical practice to evaluate which of the three techniques has greater efficacy in cytological and pathological diagnosis.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.