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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Catholic University of the Sacred Heart.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
VU University of Amsterdam
Erasme University Hospital
Information provided by (Responsible Party):
Guido Costamagna, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01673945
First received: July 12, 2012
Last updated: August 24, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention
Solid Lesions of the GI Tract or of Adjacent Organs
Device: EUS-guided fine needle aspiration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
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

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • Technical performance of the CLA-EUS versus FV-EUS for EUS-FNA [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    (i)Successful lesion identification. (ii)Successful execution of EUS-FNA proved by EUS image confirming the needle into the lesion.


Secondary Outcome Measures:
  • Diagnostic performance of the CLA-EUS versus FV-EUS for EUS-FNA [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

  • Ease of procedure [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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?

  • Rate of complications [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 124
Study Start Date: June 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EUS-FNA with the CLA-EUS Device: 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
Experimental: EUS-FNA With the FV-EUS Device: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673945

Locations
Belgium
Erasme University Hospital Recruiting
Brussels, Belgium
Contact: Pierre Eisendrath       Pierre.Eisendrath@erasme.ulb.ac.be   
Italy
Universita' del Sacro Cuore Recruiting
Rome, Italy, 00136
Contact: Alberto Larghi, MD    +390630156580    albertolargho@yahoo.it   
Netherlands
University of Amsterdam medical center Recruiting
Amsterdam, Netherlands
Contact: Jeanin van Hooft, MD       j.e.vanHooft@amc.uva.nl   
Sponsors and Collaborators
Catholic University of the Sacred Heart
VU University of Amsterdam
Erasme University Hospital
  More Information

No publications provided

Responsible Party: Guido Costamagna, Professor of Surgery, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01673945     History of Changes
Other Study ID Numbers: P69/CE/2011
Study First Received: July 12, 2012
Last Updated: August 24, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Catholic University of the Sacred Heart:
EUS-FNA, Forward viewing EUS scope, accuracy, Curvilinear EUS scope

ClinicalTrials.gov processed this record on November 20, 2014