Endoscopic Ultrasonography With Tissue AcquisitionMOSENCT04486274
Macroscopic on Site Evaluation (MOLSE) vs Standard Specimen Acquisition of Solid Lesions During EUS-FNB
A study testing MOSE in people with Endoscopic Ultrasonography With Tissue Acquisition, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Endoscopic ultrasonography (EUS) with tissue acquisition (TA) is nowadays a well-established technique for the sampling of solid lesions pancreatic and non-pancreatic lesions. Actually the standard methods to obtain sampling in gastrointestinal (GI) and non-GI solid masses is the fine needle aspiration (FNA) performed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopic Ultrasonography With Tissue Acquisition
- What is being tested?
- MOSE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteItaly
- Study dates
- 17 Jul 2020to 31 Jul 2021
- 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
- Age greater than 18, both genders.
- Both in-patient and out-patients.
- Presence of a solid lesion. In the presence of a cystic component, the solid part of the lesion should be more 75% of the total.
- FNB performed by a 22G needle Acquire® (Boston Scientific).
- Tissue acquisition with fanning technique.
- Obtained informed consent.
Who cannot join
- Patients underwent EUS-FNA with or without ROSE
- Patients underwent EUS-FNB plus ROSE.
- Previous biopsy of the lesion with diagnosis of malignancy
- Presence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.
- Pregnancy or breast-feeding.
- Patients unable to understand and/or read the consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Macroscopic on Site Evaluation (MOLSE) vs Standard Specimen Acquisition of Solid Lesions During EUS-FNB: a Randomized Controlled Trial
Endoscopic ultrasonography (EUS) with tissue acquisition (TA) is nowadays a well-established technique for the sampling of solid lesions pancreatic and non-pancreatic lesions. Actually the standard methods to obtain sampling in gastrointestinal (GI) and non-GI solid masses is the fine needle aspiration (FNA) performed by endoscopic ultrasonography (EUS). Its sensitivity, specificity and diagnostic accuracy for malignant cytology are actually reported of 85-95%, 95%-98% and 78-95% respectively. These data could be affected by the presence of cytopathologist in endoscopy room during the tissue sampling. The rapid on-site evaluation (ROSE) has been advocated to significantly increase EUS-FNA accuracy. To overcome this problem fine needle biopsy (FNB) for TA to obtain histological specimens was proposed. These needles allow as the acquisition of an histological specimen than the cytological one with FNA needles. Recently, the need to obtain a histological, instead of a cytological, specimen during EUS has become more urgent and necessary due to innovative oncological treatment options. An acquired histological specimen could avoid the need of a cytopathologist in the endoscopic room, diminishing costs, procedures time, number of passes and reducing the additional costs of a possible repeated EUS-FNA, in case of an inconclusive diagnosis.
With the advent of FNB, the macroscopic on-site evaluation (MOSE) of the specimen by the endosonographer was proposed, resulting in a comparable alternative to ROSE.
- Being tested
- MOSE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOSEOther
After each pass, the stylet will be introduced into the needle, the material will be released onto a smear slide, and a macroscopic on-site quality evaluation (MOSE) of the specimen will be performed by the endoscopist.
| Study group | Role | What they receive |
|---|---|---|
| non MOSE arm | Experimental | Three needle passes will be performed for each mass Receives: Other: MOSE |
| MOSE arm | Experimental | The endoscopist will perform biopsy until a macroscopic visible core (MVC) will be obtained and specimen will be placed in a container (Container A-MOSE). If the needle passes performed are less than 3 (1 or 2 passes) the specimens acquired in the remnant passes to join standard care of 3 passes, according to ESGE guidelines, will be placed in a second container (Container B). Receives: Other: MOSE |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the diagnostic accuracy of EUS-FNB with MOSE vs EUS-FNB alone.
Diagnostic accuracy will be measure
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start17 Jul 2020
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
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 Ultrasonography With Tissue AcquisitionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Clinico Humanitas Mater Domini
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486274
- Sponsor's protocol ID
- 10-2020
- Acronym
- MOSE
- Status last verified
- Jul 2020
- First submitted
- 17 Jul 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mangiavillano B, Crino SF, Facciorusso A, Di Matteo F, Barbera C, Larghi A, Rizzatti G, Carrara S, Spadaccini M, Auriemma F, Fabbri C, Binda C, Coluccio C, Marocchi G, Staiano T, Conti Bellocchi MC, Bernardoni L, Eusebi LH, Cirota GG, De Nucci G, Stigliano S, Manes G, Bonanno G, Ofosu A, Lamonaca L, Paduano D, Spatola F, Repici A. Endoscopic ultrasound-guided fine-needle biopsy with or without macroscopic on-site evaluation: a randomized controlled noninferiority trial. Endoscopy. 2023 Feb;55(2):129-137. doi: 10.1055/a-1915-5263. Epub 2022 Aug 31.
PubMed 36044915
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macroscopic on Site Evaluation (MOLSE) vs Standard Specimen Acquisition of Solid Lesions During EUS-FNB: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04486274
- Acronym / sponsor ID
- MOSE / 10-2020
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Collaborators
- Istituto Clinico Humanitas Mater Domini
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 24 Jul 2020 (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.
Endoscopic ultrasonography (EUS) with tissue acquisition (TA) is nowadays a well-established technique for the sampling of solid lesions pancreatic and non-pancreatic lesions. Actually the standard methods to obtain sampling in gastrointestinal (GI) and non-GI solid masses is the fine needle aspiration (FNA) performed by endoscopic ultrasonography (EUS). Its sensitivity, specificity and diagnostic accuracy for malignant cytology are actually reported of 85-95%, 95%-98% and 78-95% respectively. These data could be affected by the presence of cytopathologist in endoscopy room during the tissue sampling. The rapid on-site evaluation (ROSE) has been advocated to significantly increase EUS-FNA accuracy. To overcome this problem fine needle biopsy (FNB) for TA to obtain histological specimens was proposed. These needles allow as the acquisition of an histological specimen than the cytological one with FNA needles. Recently, the need to obtain a histological, instead of a cytological, specimen during EUS has become more urgent and necessary due to innovative oncological treatment options. An acquired histological specimen could avoid the need of a cytopathologist in the endoscopic room, diminishing costs, procedures time, number of passes and reducing the additional costs of a possible repeated EUS-FNA, in case of an inconclusive diagnosis.
With the advent of FNB, the macroscopic on-site evaluation (MOSE) of the specimen by the endosonographer was proposed, resulting in a comparable alternative to ROSE.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non MOSE arm | Experimental | Other: MOSEThree needle passes will be performed for each mass |
| MOSE arm | Experimental | Other: MOSEThe endoscopist will perform biopsy until a macroscopic visible core (MVC) will be obtained and specimen will be placed in a container (Container A-MOSE). If the needle passes performed are less than 3 (1 or 2 passes) the specimens acquired in the remnant passes to join standard care of 3 passes, according to ESGE guidelines, will be placed in a second container (Container B). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than 18, both genders.
- Both in-patient and out-patients.
- Presence of a solid lesion. In the presence of a cystic component, the solid part of the lesion should be more 75% of the total.
- FNB performed by a 22G needle Acquire® (Boston Scientific).
- Tissue acquisition with fanning technique.
Key exclusion criteria (6 listed)
- Patients underwent EUS-FNA with or without ROSE
- Patients underwent EUS-FNB plus ROSE.
- Previous biopsy of the lesion with diagnosis of malignancy
- Presence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.
- Pregnancy or breast-feeding.
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 |
|---|---|---|
| MOSEAfter each pass, the stylet will be introduced into the needle, the material will be released onto a smear slide, and a macroscopic on-site quality evaluation (MOSE) of the specimen will be performed by the endoscopist. | Other | MOSE arm, non MOSE arm |
Primary outcome
To assess the diagnostic accuracy of EUS-FNB with MOSE vs EUS-FNB alone.
Time frame: 12 Months
Diagnostic accuracy will be measure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Derived from this study: PubMed 36044915Mangiavillano B, Crino SF, Facciorusso A, Di Matteo F, Barbera C, Larghi A, Rizzatti G, Carrara S, Spadaccini M, Auriemma F, Fabbri C, Binda C, Coluccio C, Marocchi G, Staiano T, Conti Bellocchi MC, Bernardoni L, Eusebi LH, Cirota GG, De Nucci G, Stigliano S, Manes G, Bonanno G, Ofosu A, Lamonaca L, Paduano D, Spatola F, Repici A. Endoscopic ultrasound-guided fine-needle biopsy with or without macroscopic on-site evaluation: a randomized controlled noninferiority trial. Endoscopy. 2023 Feb;55(2):129-137. doi: 10.1055/a-1915-5263. Epub 2022 Aug 31.
- Individual participant dataSharing planned: No
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 MOSE in people with Endoscopic Ultrasonography With Tissue Acquisition, run by Istituto Clinico Humanitas 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 Jul 2020. 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?
Results are not available in the source record.
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?
To assess the diagnostic accuracy of EUS-FNB with MOSE vs EUS-FNB alone. (time frame: 12 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 NCT04486274, 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 24 Jul 2020; AzTrials last refreshed its copy on 1 Nov 2026.