Endoscopic UltrasoundWEST-FNBNCT04834193
Wet-suction Versus Slow-pull for EUS-FNB of Solid Lesions
A study testing Endoscopic ultrasound-guided fine-needle biopsy in people with Endoscopic Ultrasound and Fine-needle Aspiration, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopic Ultrasound, Fine-needle Aspiration
- What is being tested?
- Endoscopic ultrasound-guided fine-needle biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 29 Mar 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Solid pancreatic lesions 3 1cm
- Peri-GI tract lymph nodes 3 1cm
- Peri-GI tract masses
- Lesions of the GI wall
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wet-suction Versus Slow-pull Technique for Endoscopic Ultrasound-guided Fine-needle Biopsy of Solid Lesions: a Multicentric Randomized Controlled Trial
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.
- Conditions
- Endoscopic Ultrasound, Fine-needle Aspiration
- Being tested
- Endoscopic ultrasound-guided fine-needle biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasound-guided fine-needle biopsyProcedure or surgery
Solid lesions will be sampled under endoscopic ultrasound guidance using the two techniques (wet-suction and slow-pull)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Endoscopic ultrasound-guided fine-needle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (4)
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)
Measured: 6 months
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)
Measured: 6 months
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).
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start29 Mar 2021
- Primary completion30 Oct 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endoscopic UltrasoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Francesco Crinò, MD, Azienda Ospedaliera Universitaria Integrata Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834193
- Sponsor's protocol ID
- 18/22.09.2020
- Acronym
- WEST-FNB
- Status last verified
- Feb 2023
- First submitted
- 29 Mar 2021
- Last updated
- 2 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35915956
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wet-suction Versus Slow-pull Technique for Endoscopic Ultrasound-guided Fine-needle Biopsy of Solid Lesions: a Multicentric Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04834193
- Acronym / sponsor ID
- WEST-FNB / 18/22.09.2020
- Conditions
- Endoscopic Ultrasound, Fine-needle Aspiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WET-SUCTION | Experimental | Procedure: Endoscopic ultrasound-guided fine-needle biopsyThe 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. |
| SLOW-PULL | Active comparator | Procedure: Endoscopic ultrasound-guided fine-needle biopsyAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Solid pancreatic lesions 3 1cm
- Peri-GI tract lymph nodes 3 1cm
- Peri-GI tract masses
- Lesions of the GI wall
- Signed informed consent
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic ultrasound-guided fine-needle biopsySolid lesions will be sampled under endoscopic ultrasound guidance using the two techniques (wet-suction and slow-pull) | Procedure or surgery | SLOW-PULL, WET-SUCTION |
Primary outcome
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
4 secondary outcomes
Tissue integrity
Time frame: 6 months
Blood contamination
Time frame: 6 months
Tumor fraction
Time frame: 6 months
Diagnostic accuracy
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Derived from this study: PubMed 35915956Crino 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic ultrasound-guided fine-needle biopsy in people with Endoscopic Ultrasound and Fine-needle Aspiration, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histologic yield (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04834193, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.