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Evaluation of a New EUS Guided Biopsy Needle (SharkCore) Comparing to Standard EUS Needle (ProCore)

Primary Purpose

Mesenchymal Tumor, Autoimmune Pancreatitis, Lymphoma

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EUS-FNB with ProCore needle
EUS-FNB with SharkCore needle
ProCore needle
SharkCore needle
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Mesenchymal Tumor focused on measuring SharkCore, ProCore

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients ≥ 18 years of age referred for EUS

Lesions requiring histologic diagnosis:

  • Mesenchymal tumors
  • Autoimmune pancreatitis
  • Granulomatous disease
  • Indeterminate hepatitis
  • Confirmatory immunochemistry to establish a diagnosis (i.e. pancreatic neuroendocrine tumor)
  • Lymphoma
  • Solid tumors
  • Previously non-diagnostic FNA

Exclusion Criteria:

  • Uncorrectable coagulopathy (INR > 1.5)
  • Uncorrectable thrombocytopenia (platelet < 50,000)
  • Uncooperative patients
  • Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures)
  • Refusal to consent form
  • Cystic lesions
  • Inaccessible lesions to EUS (proximal to sigmoid colon or distal to second duodenum)

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

EUS-FNB with ProCore needle

EUS-FNB with SharkCore needle

Arm Description

General anesthesia or conscious sedation will be started and an upper endoscopic ultrasound will be inserted into the participants mouth and advanced to the site of the lesion. The lesion will be punctured by the ProCore needle, then the stylet is completely removed, and negative suction pressure is applied using a 10 ml syringe for 30 seconds while the needle is stationary with the target. Then, the needle is moved back and forth several times within the target, utilizing the fanning technique. Finally, suction is released by closing the lock of the syringe and the needle is removed.

The procedure will be done in the same manner with same endoscopic technique and method of tissue procurement. The only difference will be using the SharkCore needle to acquire tissue.

Outcomes

Primary Outcome Measures

Diagnostic accuracy of needle as assessed by diagnostic yield of needle and final diagnosis method
The final diagnosis of tissue from needle will be compared to the final diagnosis reached either by surgical removal of mass or other method of biopsy

Secondary Outcome Measures

Number of passes to procure core tissue from needle
The number of passes needed to acquire core tissue as assessed by the pathologist in the room.
Safety of tissue procurement by needle
All complications related to needle used will be recorded with a preset questionnaire to measure the frequency of complications related to needle used.
Procedure time
Time required to acquire tissue using each needle will be recorded from time of needle insertion to time of core tissue procurement as per pathologist.

Full Information

First Posted
May 6, 2016
Last Updated
May 11, 2017
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT02766842
Brief Title
Evaluation of a New EUS Guided Biopsy Needle (SharkCore) Comparing to Standard EUS Needle (ProCore)
Official Title
Evaluation of a New EUS Guided Biopsy Needle (SharkCore) Comparing to Standard EUS Needle (ProCore): A Prospective Randomized, Controlled Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Why Stopped
The reason was the fact that the ProCore needle was removed from clinical use
Study Start Date
April 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Diagnosis of lesions of pancreas, the upper gastrointestinal tract, as well as adjacent structures, such as lymph nodes, is still showing advancements especially with the increased use of endoscopic ultrasound. Endoscopic ultrasound-guided fine needle aspiration and fine needle biopsy (EUS-FNA/FNB) have become mainstay diagnostic techniques for these lesions. The purpose of the study is to compare between the currently used, ProCore needles and the new biopsy needle, SharkCore, for the histological diagnosis and evaluation of lesions.
Detailed Description
Endoscopic ultrasound-guided fine needle aspiration and fine needle biopsy (EUS-FNA/FNB) have become mainstay diagnostic techniques for the diagnosis and evaluation of lesions of the pancreas, the upper gastrointestinal tract, as well as adjacent structures, including lymph nodes. Cytology specimens provided from FNA cannot fully characterize certain neoplasms such as lymphomas or mesenchymal tumors. Core biopsy specimens for histological examinations are needed to provide accurate diagnoses. ProCore needles (ProCore, Wilson-Cook Medical Inc. Winston-Salem, NC) were designed to obtain histological and cytological samples. Studies comparing ProCore needles with standard FNA needles showed no significant difference in diagnostic accuracy, histological core tissue procurement or mean number of passes. To overcome the above mentioned limitations (mainly suboptimal core tissue procurement rates), a new novel SharkCore needle (Beacon Endoscopic, Newton, MA, USA) has been designed and approved for clinical human use by the FDA. The objective of the study is to compare the new EUS guided histology biopsy needle SharkCore to the currently used EUS histology needle, ProCore, for the histological diagnosis and evaluation of lesions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesenchymal Tumor, Autoimmune Pancreatitis, Lymphoma, Solid Tumors
Keywords
SharkCore, ProCore

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EUS-FNB with ProCore needle
Arm Type
Active Comparator
Arm Description
General anesthesia or conscious sedation will be started and an upper endoscopic ultrasound will be inserted into the participants mouth and advanced to the site of the lesion. The lesion will be punctured by the ProCore needle, then the stylet is completely removed, and negative suction pressure is applied using a 10 ml syringe for 30 seconds while the needle is stationary with the target. Then, the needle is moved back and forth several times within the target, utilizing the fanning technique. Finally, suction is released by closing the lock of the syringe and the needle is removed.
Arm Title
EUS-FNB with SharkCore needle
Arm Type
Active Comparator
Arm Description
The procedure will be done in the same manner with same endoscopic technique and method of tissue procurement. The only difference will be using the SharkCore needle to acquire tissue.
Intervention Type
Procedure
Intervention Name(s)
EUS-FNB with ProCore needle
Intervention Description
The use of the standard ProCore needle to acquire diagnostic tissue
Intervention Type
Procedure
Intervention Name(s)
EUS-FNB with SharkCore needle
Intervention Description
The use of new SharkCore needle to acquire diagnostic tissue
Intervention Type
Device
Intervention Name(s)
ProCore needle
Intervention Description
This is the standard needle used currently to procure tissue from lesions under endoscopic ultrasound guidance
Intervention Type
Device
Intervention Name(s)
SharkCore needle
Intervention Description
This is the new FDA approved needle for tissue procurement under endoscopic ultrasound guidance.
Primary Outcome Measure Information:
Title
Diagnostic accuracy of needle as assessed by diagnostic yield of needle and final diagnosis method
Description
The final diagnosis of tissue from needle will be compared to the final diagnosis reached either by surgical removal of mass or other method of biopsy
Time Frame
Up to 1 month
Secondary Outcome Measure Information:
Title
Number of passes to procure core tissue from needle
Description
The number of passes needed to acquire core tissue as assessed by the pathologist in the room.
Time Frame
During procedure
Title
Safety of tissue procurement by needle
Description
All complications related to needle used will be recorded with a preset questionnaire to measure the frequency of complications related to needle used.
Time Frame
Up to 1 year
Title
Procedure time
Description
Time required to acquire tissue using each needle will be recorded from time of needle insertion to time of core tissue procurement as per pathologist.
Time Frame
During procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients ≥ 18 years of age referred for EUS Lesions requiring histologic diagnosis: Mesenchymal tumors Autoimmune pancreatitis Granulomatous disease Indeterminate hepatitis Confirmatory immunochemistry to establish a diagnosis (i.e. pancreatic neuroendocrine tumor) Lymphoma Solid tumors Previously non-diagnostic FNA Exclusion Criteria: Uncorrectable coagulopathy (INR > 1.5) Uncorrectable thrombocytopenia (platelet < 50,000) Uncooperative patients Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures) Refusal to consent form Cystic lesions Inaccessible lesions to EUS (proximal to sigmoid colon or distal to second duodenum)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mouen Khashab, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Evaluation of a New EUS Guided Biopsy Needle (SharkCore) Comparing to Standard EUS Needle (ProCore)

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