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22 Gauge Needle for EUS Guided Tissue Acquisition of Samples for Histologic Examination (EUSFNTA)

Primary Purpose

Abdominal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Fine Needle Tissue Acquisition
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Abdominal Neoplasms focused on measuring EUS-guided biopsy

Eligibility Criteria

10 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age greater than 18 and less than 80.
  • Presence of a solid lesion within or adjacent of the gastrointestinal tract. In the presence of a cystic component, the solid part of the lesion should be more 75% of the total.
  • Absence 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.
  • Informed consent is obtained

Exclusion Criteria:

  • 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.
  • They are unable to understand and/or read the consent form.

Sites / Locations

  • ISMETT
  • Universita cattolica del sacro cuore

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adominal neoplasms patients

Arm Description

Patients in whom EUS-FNTA is performed with a novel type of biopsy neede.

Outcomes

Primary Outcome Measures

- Yield, as defined by the percentage of patients in whom a histologically interpretable specimen will be retrieved by EUS-FNTA.
diagnostic accuracy

Secondary Outcome Measures

rate of complications
- The rate of complications, divided in procedural complication (perforation, bleeding) occurring during the procedure and late complications (delayed bleeding, infection) occurring during the post-procedural observational period.

Full Information

First Posted
January 19, 2015
Last Updated
July 24, 2019
Sponsor
Catholic University of the Sacred Heart
Collaborators
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
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1. Study Identification

Unique Protocol Identification Number
NCT04032951
Brief Title
22 Gauge Needle for EUS Guided Tissue Acquisition of Samples for Histologic Examination
Acronym
EUSFNTA
Official Title
Evaluation of a Newly Designed 22 Gauge Needle for EUS Guided Tissue Acquisition of Samples for Histologic Examination in Patients With Solid Lesions: A Prospective Two Centers Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart
Collaborators
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine the yield of tissue biopsy specimen and the diagnostic accuracy of tissue acquisition using a newly developed 22 gauge needle in patients with solid lesions throughout the GI tract.
Detailed Description
The use of 22 gauge needle to gather tissue samples under EUS guidance has not been associated with an increased risk, and no major complications have been described so far both for the 22 gauge Procore needle and for standard 22 gauge.20, 21 Potential benefits of this new needle are the possibility of increasing the chance of retrieving tissue specimens for histological examination, with the possibility of increasing the diagnostic accuracy of the procedure saving the need and the cost deriving from on-site cytopathology examination. This may reduce the need to repeat EUS procedures or other more invasive sampling procedures, including surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Neoplasms
Keywords
EUS-guided biopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adominal neoplasms patients
Arm Type
Experimental
Arm Description
Patients in whom EUS-FNTA is performed with a novel type of biopsy neede.
Intervention Type
Other
Intervention Name(s)
Fine Needle Tissue Acquisition
Other Intervention Name(s)
FNTA
Intervention Description
diagnostic
Primary Outcome Measure Information:
Title
- Yield, as defined by the percentage of patients in whom a histologically interpretable specimen will be retrieved by EUS-FNTA.
Description
diagnostic accuracy
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
rate of complications
Description
- The rate of complications, divided in procedural complication (perforation, bleeding) occurring during the procedure and late complications (delayed bleeding, infection) occurring during the post-procedural observational period.
Time Frame
perioperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age greater than 18 and less than 80. Presence of a solid lesion within or adjacent of the gastrointestinal tract. In the presence of a cystic component, the solid part of the lesion should be more 75% of the total. Absence 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. Informed consent is obtained Exclusion Criteria: 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. They are unable to understand and/or read the consent form.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GUIDO COSTAMAGNA, PROF
Organizational Affiliation
Catholic University of the Sacred Heart
Official's Role
Study Director
Facility Information:
Facility Name
ISMETT
City
Palermo
Country
Italy
Facility Name
Universita cattolica del sacro cuore
City
Rome
Country
Italy

12. IPD Sharing Statement

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22 Gauge Needle for EUS Guided Tissue Acquisition of Samples for Histologic Examination

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