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Completed

NCT Number: NCT04834193

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

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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Key information

Conditions

Endoscopic Ultrasound Fine-needle Aspiration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliera Integrata Verona

Verona, 37134, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic ultrasound-guided fine-needle biopsy

Procedure

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

Primary outcomes

  1. Histologic yield

    Time frame: 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 outcomes

  1. Tissue integrity

    Time frame: 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

    • 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)

  2. Blood contamination

    Time frame: 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

    • High blood contamination (>50% of the surface)
    • Moderate blood contamination (25-50% of the surface)
    • Low blood contamination (<25% of the surface)

  3. Tumor fraction

    Time frame: 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).

  4. Diagnostic accuracy

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Other

Registry information

Official study title

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

Acronym: WEST-FNB

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 8, 2021
Registry last updated
Feb 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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