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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-29

Study Completion Date

2022-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Endoscopic Ultrasound Fine-needle Aspiration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Endoscopic ultrasound-guided fine-needle biopsy

Intervention Type PROCEDURE

Solid lesions will be sampled under endoscopic ultrasound guidance using the two techniques (wet-suction and slow-pull)

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After puncturing the lesion, the stylet will be slowly and gradually withdrawn for at least 40cm.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.

Group Type ACTIVE_COMPARATOR

Endoscopic ultrasound-guided fine-needle biopsy

Intervention Type PROCEDURE

Solid lesions will be sampled under endoscopic ultrasound guidance using the two techniques (wet-suction and slow-pull)

Interventions

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Endoscopic ultrasound-guided fine-needle biopsy

Solid lesions will be sampled under endoscopic ultrasound guidance using the two techniques (wet-suction and slow-pull)

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No