FV-EUS Endoscope Versus CLA-EUS for EUS-FNA of Solid Lesions

NCT ID: NCT01673945

Last Updated: 2019-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-01-31

Brief Summary

The intent of this study is to compare the performance of the CLA-EUS versus the FV-EUS in the performance of EUS-FNA of patients with solid lesions of the GI tract and of adjacent organs, with the aim of establishing for which lesions and from which location the capability of the FV-EUS will be superior, equal or, inferior to the CLA-EUS

Detailed Description

Recently, a forward viewing linear echoendoscope (FV-EUS) has been developed with the aim of potentially expanding the therapeutic applications of EUS. This prototype is a modification of the CLA scope and it is characterized primarily by a shifting of the orientation of the endoscopic and US views from oblique to forward. The US transducer is located adjacent to the working channel, at the endoscope tip, to display a forward-viewing image along to a scanning plane that is parallel to the insertion direction with a 90° scanning range. It has a 3.7 mm working channel without elevator, which allows exit of the FNA needle or any other accessory used parallel to the longitudinal axis of the scope.

Preliminary experiences with this scope have reported potential advantages over the conventional linear scope (CLA-EUS) for pseudocysts drainage and for hilar biliary strictures. Moreover, a large experience still unpublished from the Catholic University, Rome, Italy in the use of the FV-EUS for FNA of solid and cystic lesions throughout the GI tract has shown the FV-EUS to be highly effective with a performance that seems at least comparable to that of the CLA-EUS. To date, however, no data comparing the performance of both scopes for FNA of target lesions are available to better clarify the advantages and disadvantages of one scope over the other.

We designed a randomized comparative trial in which patients will be randomized to undergo examination with CLA-EUS or with FV-EUS. In case of failure of: (i) visualization of the presumed lesion; (ii) failure in performing the FNA with the scope used based on randomization, a second attempt will be made using the other scope.

Conditions

Solid Lesions of the GI Tract or of Adjacent Organs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

EUS-FNA with the CLA-EUS

patients examined with the CLA-EUS

Group Type: ACTIVE_COMPARATOR

EUS-guided fine needle aspiration

Intervention Type: DEVICE

Each patient will undergo examination with the CLA-EUS or the FV-EUS, which will be selected based on the randomization process. FV-EUS will be performed using the newly available FV -EUS scope (TGF-Y0001-UC) that is compatible with last generation Aloka alpha 10. First, search of the presumed lesion will be performed and once visualize, its characteristics (size, echogenicity, margins, etc) will be recorded on data collection sheet. Fine needle aspiration will be performed under EUS guidance using a 19- ,22- or a 25-gauge fine needle or procore needles depending on endoscopist's preference

EUS-FNA With the FV-EUS

patients examined with the FV-EUS

Group Type: EXPERIMENTAL

EUS-guided fine needle aspiration

Intervention Type: DEVICE

Each patient will undergo examination with the CLA-EUS or the FV-EUS, which will be selected based on the randomization process. FV-EUS will be performed using the newly available FV -EUS scope (TGF-Y0001-UC) that is compatible with last generation Aloka alpha 10. First, search of the presumed lesion will be performed and once visualize, its characteristics (size, echogenicity, margins, etc) will be recorded on data collection sheet. Fine needle aspiration will be performed under EUS guidance using a 19- ,22- or a 25-gauge fine needle or procore needles depending on endoscopist's preference

Interventions

EUS-guided fine needle aspiration

Each patient will undergo examination with the CLA-EUS or the FV-EUS, which will be selected based on the randomization process. FV-EUS will be performed using the newly available FV -EUS scope (TGF-Y0001-UC) that is compatible with last generation Aloka alpha 10. First, search of the presumed lesion will be performed and once visualize, its characteristics (size, echogenicity, margins, etc) will be recorded on data collection sheet. Fine needle aspiration will be performed under EUS guidance using a 19- ,22- or a 25-gauge fine needle or procore needles depending on endoscopist's preference

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Presence of a solid lesion in the GI tract or in one of the adjacent organs identified at abdominal US, CT, MRI/MRCP that needs to be samples with EUS-FNA because unresectable or because tissue characterization is needed to decide further treatment modalities

2. Age greater than 18.

3. Absence of histological or cytological confirmation of malignancy.

4. Informed consent obtained.

Exclusion Criteria

1. Patients with active coagulopathy that cannot be corrected after administration of plasma.

2. Resectable lesions that does not need tissue characterization to decide treatment modalities.

3. Pregnancy.

4. Patients who cannot give inform consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Amsterdam

OTHER

Sponsor Role: collaborator

Erasme University Hospital

OTHER

Sponsor Role: collaborator

Catholic University of the Sacred Heart

OTHER

Sponsor Role: lead

Responsible Party

Guido Costamagna

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alberto Larghi, MD

Role: PRINCIPAL_INVESTIGATOR

Universita' del Sacro Cuore

Locations

Erasme University Hospital

Brussels, , Belgium

Universita' del Sacro Cuore

Rome, , Italy

University of Amsterdam medical center

Amsterdam, , Netherlands

Countries

Belgium; Italy; Netherlands

References

Larghi A, Ibrahim M, Fuccio L, Lekkerkerker S, Eisendrath P, Frazzoni L, Fockens P, La Marca M, van Hooft JE, Deviere J, Costamagna G. Forward-viewing echoendoscope versus standard echoendoscope for endoscopic ultrasound-guided tissue acquisition of solid lesions: a randomized, multicenter study. Endoscopy. 2019 May;51(5):444-451. doi: 10.1055/a-0790-8342. Epub 2018 Nov 29.

Reference Type: DERIVED

PMID: 30497087 (View on PubMed)

Other Identifiers

P69/CE/2011

Identifier Type: -

Identifier Source: org_study_id