Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

A Clinical Trial With a New Needle Device Comparing Two Needles for EUS_FNA of Solid Lesions. (EUS-FNA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02246322
Recruitment Status : Unknown
Verified September 2014 by Michele Tedeschi, Istituto Clinico Humanitas.
Recruitment status was:  Recruiting
First Posted : September 22, 2014
Last Update Posted : September 22, 2014
Sponsor:
Information provided by (Responsible Party):
Michele Tedeschi, Istituto Clinico Humanitas

Brief Summary:

Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) is a reliable, safe, and effective technique for obtaining samples from the GI wall lesions and from organs adjacent to the GI tract (pancreas, nodes...).Needles available for EUS-FNA include 25G, 22G and 19G. Some studies have suggested that the 25G needle could be equal or even better than the 22G needle.

The BXN system and neddles are is a newly developed for EUS-FNA. This trial is developed for testing the accuracy of the new neddle system for EUS-FNA and for comparing the two needles types, 25G and 22G.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Neuroendocrine Tumors Lymphadenopathies GIST Gastric Wall Tumor Device: 25G needle Device: 22G needle Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Randomized Clinical Trial With a New Needle Device Comparing 25G and 22G Needle in Endoscopic Ultrasound Fine-needle Aspiration of Solid Lesions.
Study Start Date : August 2013
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : November 2014


Arm Intervention/treatment
Experimental: 25G needle
All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).
Device: 25G needle
All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).

Experimental: 22G needle
All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).
Device: 22G needle
All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).




Primary Outcome Measures :
  1. Clinical performance of 22G and 25G needles [ Time Frame: 18 months ]
    Evaluation of whether enough material for adequate cytological/histological analysis can obtained with equal efficacy with the 25G and the 22G needles. The percentages of adequate samples obtained.


Secondary Outcome Measures :
  1. Ease of needle pass [ Time Frame: 18 months ]
    The subjective evaluation of the operator (easy or hard)

  2. Needle malfunction [ Time Frame: 18 months ]
    Needles do not come out of the cover; kinking; needles do not puncture the tissue (presence or absence of malfunction, and registering of the specific malfunction)

  3. Number of passes [ Time Frame: 18 months ]
    The total number of passes needed to obtain adequate material for each lesion (absolute number).

  4. Number of crossovers [ Time Frame: 18 months ]
    The times when the need for passage from the 22G to the 25G needle, or vice versa, registered as percentages of the total procedures.

  5. Major complications [ Time Frame: 18 months ]
    Bleeding (minor: visible at EUS but without clinical significance or less than 2 g/dl; major: dropping of more than 2 g/dl in Hb levels and clinically significant), perforation (presence/absence), infection (need for hospitalization).



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • endosonographic appearance of a solid lesions
  • age >18 years
  • informed consent.

Exclusion Criteria:

  • alteration of the coagulation (INR >1.5, PLT <50 x 103 /µL)
  • inability to express consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246322


Contacts
Layout table for location contacts
Contact: Silvia Carrara, MD +390282247288 silvia.carrara@humanitas.it

Locations
Layout table for location information
Italy
Humanitas Research Hospital Recruiting
Rozzano, Milan, Italy, 20089
Contact: Alessandro Repici, MD    +390282247493    alessadro.repici@humanitas.it   
Principal Investigator: Silvia Carrara, MD         
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
Layout table for investigator information
Principal Investigator: Silvia Carrara, MD Humanitas Research Hospital

Publications:
Layout table for additonal information
Responsible Party: Michele Tedeschi, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT02246322    
Other Study ID Numbers: BNX-1
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: September 22, 2014
Last Verified: September 2014
Keywords provided by Michele Tedeschi, Istituto Clinico Humanitas:
Pancreatic cancer
Neuroendocrine tumors
Lymphadenopathies
GIST
Gastrointestinal wall neoplasia
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Neuroendocrine Tumors
Lymphadenopathy
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Lymphatic Diseases