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

Wet-suction Versus Slow-pull Technique for Endoscopic Ultrasound-guided Fine-needle Biopsy of Solid Lesions: a Multicentric Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Endoscopic Ultrasound; Fine-needle Aspiration
• Intervention / Treatment: Procedure: Endoscopic ultrasound-guided fine-needle biopsy

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Verona, Italy, 37134
    • Azienda Ospedaliera Integrata Verona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WET-SUCTION; 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.	Procedure: Endoscopic ultrasound-guided fine-needle biopsy; Solid lesions will be sampled under endoscopic ultrasound guidance using the two techniques (wet-suction and slow-pull)
Active Comparator: SLOW-PULL; After puncturing the lesion, the stylet will be slowly and gradually withdrawn for at least 40cm.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.	Procedure: Endoscopic ultrasound-guided fine-needle biopsy; Solid lesions will be sampled under endoscopic ultrasound guidance using the two techniques (wet-suction and slow-pull)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histologic yield	The rate of samples containing a tissue "core" (yes/no) for histological evaluation, defined as an intact piece of tissue of at least 550 μ	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tissue integrity	Tissue integrity will be evaluated by attributing a score from zero to 3 (3 represents the better outcome), according to the following score system: 0: No cells/tissue; Cytological specimen (disaggregated cells representative of the target lesion not allowing for tissue architectural assessment); Histologic microfragments (sample adequate for histological evaluation, namely an architecturally intact piece of tissue but without a "core"); Histologic "core" (defined as an architecturally intact piece of tissue measuring at least 550 μ)	6 months
Blood contamination	Blood contamination will be evaluated by attributing a score from zero to 3 (3 represents the better outcome), according to the following score system: 0: Only blood; High blood contamination (>50% of the surface); Moderate blood contamination (25-50% of the surface); Low blood contamination (<25% of the surface)	6 months
Tumor fraction	The rate of samples containing an adequate tumor fraction ≥20 percent (i.e., ≥ 20 percent tumor cells in a background of benign nucleated cells).	6 months
Diagnostic accuracy	Diagnostic accuracy (defined as the ratio between the sum of true positive and true negative values divided by the number of lesions) will be calculated for each study arm	6 months

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

Publications and helpful links

General Publications

• Crino SF, Conti Bellocchi MC, Di Mitri R, Inzani F, Rimbas M, Lisotti A, Manfredi G, Teoh AYB, Mangiavillano B, Sendino O, Bernardoni L, Manfrin E, Scimeca D, Unti E, Carlino A, Voiosu T, Mateescu RB, Fusaroli P, Lega S, Buscarini E, Pergola L, Chan SM, Lamonaca L, Gines A, Fernandez-Esparrach G, Facciorusso A, Larghi A. Wet-suction versus slow-pull technique for endoscopic ultrasound-guided fine-needle biopsy: a multicenter, randomized, crossover trial. Endoscopy. 2022 Sep 27. doi: 10.1055/a-1915-1812. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Actual): October 30, 2021
• Study Completion (Anticipated): April 30, 2022

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: April 5, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 19, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 18/22.09.2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No