Solid Lesions of the GI Tract or of Adjacent OrgansNCT01673945
FV-EUS Endoscope Versus CLA-EUS for EUS-FNA of Solid Lesions
A study testing EUS-guided fine needle aspiration in people with Solid Lesions of the GI Tract or of Adjacent Organs, run by Catholic University of the Sacred Heart at 3 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Lesions of the GI Tract or of Adjacent Organs
- What is being tested?
- EUS-guided fine needle aspiration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jun 2012to Jan 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Age greater than 18.
- Absence of histological or cytological confirmation of malignancy.
- Informed consent obtained.
Who cannot join
- Patients with active coagulopathy that cannot be corrected after administration of plasma.
- Resectable lesions that does not need tissue characterization to decide treatment modalities.
- Pregnancy.
- Patients who cannot give inform consent.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Forward Viewing US Endoscope Versus Standard Viewing US Endoscope in the Performance of EUS-guided Fine Needle Aspiration of Solid Lesions of the Gastrointestinal Tract and of Adjacent Organs: A Prospective Randomized Controlled Study
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
Read the 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.
- Being tested
- EUS-guided fine needle aspiration
- Keywords
- EUS-FNA, Forward viewing EUS scope, Curvilinear EUS scope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided fine needle aspirationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| EUS-FNA with the CLA-EUS | Active comparator | patients examined with the CLA-EUS Receives: Device: EUS-guided fine needle aspiration |
| EUS-FNA With the FV-EUS | Experimental | patients examined with the FV-EUS Receives: Device: EUS-guided fine needle aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical performance of the CLA-EUS versus FV-EUS for EUS-FNA
(i)Successful lesion identification. (ii)Successful execution of EUS-FNA proved by EUS image confirming the needle into the lesion.
Measured: 6 months
Secondary outcomes (3)
Diagnostic performance of the CLA-EUS versus FV-EUS for EUS-FNA
sensitivity, specificity, and diagnostic accuracy of EUS-FNA performed with the two different EUS scopes in the evaluation of solid lesions will be determined and compared
Measured: 6 months
Ease of procedure
Ease of the procedure will be graded on a analog 5 point score as listed in the table below.
Physician will be asked to answer the following questions:
- Ease of visualization?
- Ease of puncturing?
- Ease of moving back and forth inside the lesion?
- Ease of overall procedure?
Measured: 6 months
Rate of complications
Rate of bleeding, pancreatitis, infection and perforation for each procedure will be measured by observation of the patient in the recovery area soonafter and one hour after completion of the procedure. The rate of pancreatitis and infection rate will be also assessed at 24 hours by visiting or calling the patients if discharged
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2014
- Study completionJan 2015
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 Solid Lesions of the GI Tract or of Adjacent OrgansStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Collaborators
- University of Amsterdam, Erasme University Hospital
- Responsible party
- Principal investigator, Guido Costamagna, Catholic University of the Sacred Heart
- Investigators
- Alberto Larghi, MD, Principal investigator, Universita' del Sacro Cuore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673945
- Sponsor's protocol ID
- P69/CE/2011
- Status last verified
- Jul 2019
- First submitted
- 12 Jul 2012
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30497087
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forward Viewing US Endoscope Versus Standard Viewing US Endoscope in the Performance of EUS-guided Fine Needle Aspiration of Solid Lesions of the Gastrointestinal Tract and of Adjacent Organs: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01673945
- Acronym / sponsor ID
- P69/CE/2011
- Keywords
- EUS-FNA, Forward viewing EUS scope, Curvilinear EUS scope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- University of Amsterdam, Erasme University Hospital
- Study start
- Jun 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 28 Aug 2012 (estimated)
- 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS-FNA with the CLA-EUS | Active comparator | Device: EUS-guided fine needle aspirationpatients examined with the CLA-EUS |
| EUS-FNA With the FV-EUS | Experimental | Device: EUS-guided fine needle aspirationpatients examined with the FV-EUS |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- Age greater than 18.
- Absence of histological or cytological confirmation of malignancy.
- Informed consent obtained.
Key exclusion criteria (4 listed)
- Patients with active coagulopathy that cannot be corrected after administration of plasma.
- Resectable lesions that does not need tissue characterization to decide treatment modalities.
- Pregnancy.
- Patients who cannot give inform consent.
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 |
|---|---|---|
| EUS-guided fine needle aspirationEach 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 | Device | EUS-FNA With the FV-EUS, EUS-FNA with the CLA-EUS |
Primary outcome
Technical performance of the CLA-EUS versus FV-EUS for EUS-FNA
Time frame: 6 months
(i)Successful lesion identification. (ii)Successful execution of EUS-FNA proved by EUS image confirming the needle into the lesion.
3 secondary outcomes
Diagnostic performance of the CLA-EUS versus FV-EUS for EUS-FNA
Time frame: 6 months
Ease of procedure
Time frame: 6 months
Rate of complications
Time frame: 1 month
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 26 Jul 2019.
- Derived from this study: PubMed 30497087Larghi 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.
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.
Alberto Larghi, MD principal investigator
Universita' del Sacro Cuore
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-guided fine needle aspiration in people with Solid Lesions of the GI Tract or of Adjacent Organs, run by Catholic University of the Sacred Heart at 3 sites in 3 countries.
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 4 inclusion and 4 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 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Italy, Netherlands. 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?
Technical performance of the CLA-EUS versus FV-EUS for EUS-FNA (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 NCT01673945, 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 26 Jul 2019.