Macroscopic on Site Evaluation (MOLSE) vs Standard Specimen Acquisition of Solid Lesions During EUS-FNB

NCT ID: NCT04486274

Last Updated: 2020-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 370 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-17
• Study Completion Date: 2021-07-31

Brief 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 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.

Conditions

Endoscopic Ultrasonography With Tissue Acquisition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

non MOSE arm

Three needle passes will be performed for each mass

Group Type: EXPERIMENTAL

MOSE

Intervention Type: OTHER

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.

MOSE arm

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).

Group Type: EXPERIMENTAL

MOSE

Intervention Type: OTHER

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.

Interventions

MOSE

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Inclusion in other study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Humanitas Mater Domini

UNKNOWN

Sponsor Role: collaborator

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gastrointestinal Endoscopy Unit

Castellanza, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 36044915 (View on PubMed)

Other Identifiers

10-2020

Identifier Type: -

Identifier Source: org_study_id