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

Lymphoma Clinical Trial

Official title:

Evaluation of a New EUS Guided Biopsy Needle (SharkCore) Comparing to Standard EUS Needle (ProCore): A Prospective Randomized, Controlled Multicenter Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02766842
• Other study ID #: IRB00095614
• Status: Withdrawn
• Phase: Phase 2
• First received: May 6, 2016
• Last updated: May 11, 2017
• Start date: April 2016
• Est. completion date: February 2017

Study information

• Verified date: May 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Autoimmune Pancreatitis
• Lymphoma
• Mesenchymal Tumor
• Pancreatitis
• Solid Tumors

Intervention

Procedure:
• EUS-FNB with ProCore needle
The use of the standard ProCore needle to acquire diagnostic tissue
• EUS-FNB with SharkCore needle
The use of new SharkCore needle to acquire diagnostic tissue

Device:
• ProCore needle
This is the standard needle used currently to procure tissue from lesions under endoscopic ultrasound guidance
• SharkCore needle
This is the new FDA approved needle for tissue procurement under endoscopic ultrasound guidance.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 1 month
Secondary	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.	During procedure
Secondary	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.	Up to 1 year
Secondary	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.	During procedure