Wet-suction Versus Slow-pull for EUS-FNB of Solid Lesions (WEST-FNB)

Integrated University Hospital Trust of Verona

Status: Completed

Conditions: Fine-needle Aspiration; Endoscopic Ultrasound

Treatments: Procedure: Endoscopic ultrasound-guided fine-needle biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04834193

18/22.09.2020

Details and patient eligibility

About

A randomized cross-over study investigating the impact of two different suction techniques on histological yield and sample quality of specimens collected by endoscopic ultrasound biopsy from solid lesions using histology needles.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Solid pancreatic lesions 3 1cm
• Peri-GI tract lymph nodes 3 1cm
• Peri-GI tract masses
• Lesions of the GI wall
• Signed informed consent

Exclusion criteria

• Pancreatic cystic lesions (more than 50% of the volume)
• Diameter of lesion ≤ 1 cm
• Lesion not seen at EUS
• Pregnancy
• Coagulopathy (platelet count <50.000/mm3 and/or international normalized ratio >1.5);
• Severe cardiorespiratory dysfunction precluding endoscopy;
• Failure to provide informed consent

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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200 participants in 2 patient groups

WET-SUCTION

Experimental group

Description:

The stylet will be removed and the needle will be pre-flushed with 1-2mL of saline. The lesion will then be punctured, and suction will be applied using a 10-mL pre-vacuum syringe. The sample collected will be pushed into a formalin vial with saline.

Treatment:

Procedure: Endoscopic ultrasound-guided fine-needle biopsy

SLOW-PULL

Active Comparator group

Description:

After puncturing the lesion, the stylet will be slowly and gradually withdrawn for at least 40cm. The sample will be pushed into formalin using the stylet.

Treatment:

Procedure: Endoscopic ultrasound-guided fine-needle biopsy