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

Endoscopic Ultrasound Clinical Trial

— WEST-FNB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04834193
• Other study ID #: 18/22.09.2020
• Status: Completed
• Phase: N/A
• Start date: March 29, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: February 2023
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 30, 2022
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endoscopic Ultrasound
• Fine-needle Aspiration

Intervention

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)

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Integrata Verona	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Integrata Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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