NCT04834193

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

March 29, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

February 2, 2023

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

March 29, 2021

Last Update Submit

February 1, 2023

Conditions

Endoscopic UltrasoundFine-needle Aspiration

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Tissue integrity

    6 months

  • Blood contamination

    6 months

  • Tumor fraction

    6 months

  • Diagnostic accuracy

    6 months

Study Arms (2)

WET-SUCTION

EXPERIMENTAL

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

SLOW-PULL

ACTIVE COMPARATOR

After puncturing the lesion, the stylet will be slowly and gradually withdrawn for at least 40cm.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

Interventions

Endoscopic ultrasound-guided fine-needle biopsyPROCEDURE

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

SLOW-PULLWET-SUCTION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Solid pancreatic lesions 3 1cm
  • Peri-GI tract lymph nodes 3 1cm
  • Peri-GI tract masses
  • Lesions of the GI wall
  • Signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera Integrata Verona

Verona, 37134, Italy

Location

Related Publications (1)

  • 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. 2023 Mar;55(3):225-234. doi: 10.1055/a-1915-1812. Epub 2022 Aug 1.

    PMID: 35915956DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 8, 2021

Study Start

March 29, 2021

Primary Completion

October 30, 2021

Study Completion

April 30, 2022

Last Updated

February 2, 2023

Record last verified: 2023-02

Locations

IT(1)