Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Pancreatic Cancer

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

In an endoscopic ultrasound-guided procedure, Shark Core Fine Needle Biopsy (FNB) will be performed first, followed by Fine Needle Aspiration (FNA).

In an endoscopic ultrasound-guided procedure, Fine Needle Aspiration (FNA) will be performed first, followed by Shark Core Fine Needle Biopsy (FNB).

The Shark Core FNB is an FDA approved device for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses. FNB will be performed by 22 gauge for pancreas head and by 19 gauge for all the other sites.

Fine Needle Biopsy (FNB)

Fine needle aspiration is a type of biopsy procedure. In fine needle aspiration, a thin needle is inserted into an area of abnormal-appearing tissue or body fluid, and histological material is obtained. FNA will be performed with a standard 25g needle in the usual fashion using back and forth passes for 30 seconds.

Fine Needle Aspiration (FNA)

Michael B. Wallace, MD, MPH

This is a clinical trial to compare two needles used in biopsy techniques to acquire tissue from pancreatic cancer. The hypothesis is that the tissue yield, as measured by tumor DNA and cellular material is superior for Flexible Needle Biopsy (FNB) compared with conventional Fine Needle Aspiration (FNA). Specifically, FNB will increase the proportion of cases in which sufficient DNA is obtained to allow genomic profiling and whole exome sequencing.

This is a single-blinded randomized controlled trial with paired evaluation of conventional FNA needle versus FNB needle stratified by lesion location (pancreas head tumor versus pancreas body/tail). A minimum of 4 passes ( 2 with each needle) will be performed from all the lesions. After each pass of needle, the on-site cytopathologists will evaluate the adequacy and the degree of the pathological changes in the obtained material. Based on the information provided by the onsite cytopathologists, the endosonographer will repeat the FNA until enough histological material is obtained to confirm a diagnosis. Patients will be assessed immediately after procedure and during the first 30 days with a follow-up.

Endoscopic Ultrasound Guided Fine Needle Biopsy (EUS-FNB-SC) Using a Novel Fork Needle

Pilot-Feasibility Trial of EUS Guided Pancreas Fine Needle Core Biopsy for Whole Exome Sequencing and Genomic Profiling

Total quantity of DNA obtained from first needle pass of adenocarcinoma, measured in ng/µL.

The total number of passes required to obtain adequate tissue sample for cytology/histology processing and interpretation.

The length of the tissue core sample acquired, on the first needle pass, measured in centimeters.

The concentration of the DNA from the adenocarcinoma on the first needle pass, measured in micrograms per microliter.

Percent of tumor cellularity with first pass of adenocarcinoma

The total number of subjects whose first-pass biopsy contained adequate material for cytologic interpretation, as determined by a cytopathologist.

The number of subjects whose first pass biopsy contained adequate material for high quality histologic interpretation, as determined by a cytopathologist. High quality is defined as being greater than 10 power field in length.

Medtronic

Mayo Clinic

M.D, MPH, Professor of Medicine

Fine Needle Biopsy (FNB): The Shark Core FNB is an FDA approved device for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses. FNB will be performed by 22 gauge for pancreas head and by 19 gauge for all the other sites.

Fine Needle Aspiration (FNA): Fine needle aspiration is a type of biopsy procedure. In fine needle aspiration, a thin needle is inserted into an area of abnormal-appearing tissue or body fluid, and histological material is obtained. FNA will be performed with a standard 25g needle in the usual fashion using back and forth passes for 30 seconds.

In an endoscopic ultrasound-guided procedure, Shark Core Fine Needle Biopsy (FNB) will be performed first, followed by Fine Needle Aspiration (FNA).

Fine Needle Biopsy (FNB): The Shark Core FNB is an FDA approved device for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses. FNB will be performed by 22 gauge for pancreas head and by 19 gauge for all the other sites.

Fine Needle Aspiration (FNA): Fine needle aspiration is a type of biopsy procedure. In fine needle aspiration, a thin needle is inserted into an area of abnormal-appearing tissue or body fluid, and histological material is obtained. FNA will be performed with a standard 25g needle in the usual fashion using back and forth passes for 30 seconds.

FNB First, Then FNA

In an endoscopic ultrasound-guided procedure, Fine Needle Aspiration (FNA) will be performed first, followed by Shark Core Fine Needle Biopsy (FNB).

Fine Needle Biopsy (FNB): The Shark Core FNB is an FDA approved device for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses. FNB will be performed by 22 gauge for pancreas head and by 19 gauge for all the other sites.

Fine Needle Aspiration (FNA): Fine needle aspiration is a type of biopsy procedure. In fine needle aspiration, a thin needle is inserted into an area of abnormal-appearing tissue or body fluid, and histological material is obtained. FNA will be performed with a standard 25g needle in the usual fashion using back and forth passes for 30 seconds.

FNA First, Then FNB

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Michael B. Wallace

Total DNA Yield of Adenocarcinoma

Total Number of Passes Needed to Obtain Adequate Tissue Sample for Cytology/Histology Diagnosis

Core Tissue Length

Concentration of DNA Yield of Adenocarcinoma

Percentage of Tumor Cellularity

Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for Cytologic Interpretation

Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for High Quality Histologic Interpretation

First Intervention

Second Intervention

Symptoms and General Pathology

Blood and Lymph Conditions

Immune System Diseases

Neoplasm Metastasis

Carcinoma

Carcinoma, Hepatocellular

Lymphoma

Adenocarcinoma

Cholangiocarcinoma

Neuroendocrine Tumors

Pancreatitis

Pancreatitis, Chronic

Autoimmune Pancreatitis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Diseases

Pancreatic Diseases

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Chronic Disease

Disease Attributes

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Autoimmune Diseases

Chronic Graft Versus Host Disease

Lymphosarcoma

Bile Duct Cancer

Neuroendocrine Tumor

Neuroepithelioma

Patients with use of AcuCore 22 gauge FNB to collect specimens from GI tract

Using endoscopic ultrasound guided needle to collect biopsies

EchoTip AcuCore

Shelley Farrester

The purpose of collecting this data is to continue to learn more about the EchoTip AcuCore and the device's ability to produce the desired favorable effect and if there are any undesired outcomes that may be related to the EchoTip AcuCore.

EchoTip AcuCore Post-Market Clinical Study

The ability to obtain a sample without failure of the needle system necessitating the use of a new needle to complete the procedure

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Endoscopic Ultrasound Guided Fine Needle Biopsy (EUS-FNB-SC) Using a Novel Fork Needle	NCT02678442	Pancreatic Canc...	Fine Needle Bio... Fine Needle Asp...	18 Years - 100 Years	Mayo Clinic
Endoscopic Ultrasound Guided Fine Needle Biopsy (EUS-FNB-SC) Using a Novel Fork Needle	NCT02678442	Pancreatic Canc...	Fine Needle Bio... Fine Needle Asp...	18 Years - 100 Years	Mayo Clinic
EchoTip AcuCore Post-Market Clinical Study	NCT06358001	Adenocarcinoma Neuroendocrine ... Hepatocellular ... Cholangiocarcin... Malignant Lymph... Metastasis Chronic Pancrea... Autoimmune Panc...	EchoTip AcuCore	18 Years -	Cook Group Incorporated
EchoTip AcuCore Post-Market Clinical Study	NCT06358001	Adenocarcinoma Neuroendocrine ... Hepatocellular ... Cholangiocarcin... Malignant Lymph... Metastasis Chronic Pancrea... Autoimmune Panc...	EchoTip AcuCore	18 Years -	Cook Group Incorporated

Spots Global Cancer Trial Database for fine needle biopsy (fnb)