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

Not Applicable

Completed

• Conditions: Endoscopic Ultrasound; Fine-needle Aspiration
• Interventions: Procedure: Endoscopic ultrasound-guided fine-needle biopsy

• Registration Number: NCT04834193
• Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-29
• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-04-05
• Study First Posted: 2021-04-08
• Primary Completion: 2021-10-30
• Study Completion: 2022-04-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SLOW-PULL	Endoscopic ultrasound-guided fine-needle biopsy	After puncturing the lesion, the stylet will be slowly and gradually withdrawn for at least 40cm.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.
WET-SUCTION	Endoscopic ultrasound-guided fine-needle biopsy	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.

Primary Outcome Measures

Name	Time	Method
Histologic yield	6 months	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

Secondary Outcome Measures

Name	Time	Method
Blood contamination	6 months	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; 1. High blood contamination (\>50% of the surface); 2. Moderate blood contamination (25-50% of the surface); 3. Low blood contamination (\<25% of the surface)
Tumor fraction	6 months	The rate of samples containing an adequate tumor fraction ≥20 percent (i.e., ≥ 20 percent tumor cells in a background of benign nucleated cells).
Tissue integrity	6 months	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; 1. Cytological specimen (disaggregated cells representative of the target lesion not allowing for tissue architectural assessment); 2. Histologic microfragments (sample adequate for histological evaluation, namely an architecturally intact piece of tissue but without a "core"); 3. Histologic "core" (defined as an architecturally intact piece of tissue measuring at least 550 μ)
Diagnostic accuracy	6 months	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

Trial Locations

Locations (1)

Azienda Ospedaliera Integrata Verona; 🇮🇹 Verona, Italy