Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Rare Diseases

Lymphoma

Pancreatitis

Autoimmune Pancreatitis

Pancreatic Diseases

Gastrointestinal Diseases

Pancreatitis, Chronic

Autoimmune Diseases

Chronic Disease

Disease Attributes

Lymphosarcoma

Chronic Graft Versus Host Disease

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

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.

The use of the standard ProCore needle to acquire diagnostic tissue

EUS-FNB with ProCore needle

The use of new SharkCore needle to acquire diagnostic tissue

EUS-FNB with SharkCore needle

This is the standard needle used currently to procure tissue from lesions under endoscopic ultrasound guidance

ProCore needle

This is the new FDA approved needle for tissue procurement under endoscopic ultrasound guidance.

SharkCore needle

Mouen Khashab, MD

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.

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.

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

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

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

The number of passes needed to acquire core tissue as assessed by the pathologist in the room.

All complications related to needle used will be recorded with a preset questionnaire to measure the frequency of complications related to needle used.

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.

Johns Hopkins University

Associate professor

Gland and Hormone Related Diseases

Skin and Connective Tissue Diseases

Adenocarcinoma

Gastrointestinal Stromal Tumors

Pancreatic Neoplasms

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Endocrine System Diseases

Pancreatic Cancer

Fine needle aspiration using conventional FNA for cytology

Fine needle biopsy using ProCore needle for histology.

EUS-guided biopsy of each solid lesion using the EchoTip® ProCore™ ultrasound FNB needle for histology.

EUS-guided biopsy of each solid lesion using the EchoTip® Ultra™ FNA needle for cytology.

Christopher W Teshima, MD,FRCPC

Endoscopic ultrasound (EUS) is a well-established tool for the diagnosis and staging of many gastrointestinal conditions, including but not limited to, malignant and pre-malignant neoplasms of the pancreas, esophagus, rectum, and submucosal tumors developing along the gastrointestinal tract. EUS is the most sensitive test for the detection of focal lesions within the pancreas and is the most accurate method for diagnosing pancreas cancer. A biopsy method for tissue sampling via EUS called fine needle aspiration (FNA) was developed that enables a small needle to be passed into the lesion of interest under ultrasound guidance, obtaining cellular material for cytology. EUS-FNA is currently recommended for the diagnosis of cystic and solid mass lesions within and adjacent to the gastrointestinal tract. Yet in certain clinical circumstances, it is more desirable and sometimes necessary to obtain a core tissue biopsy for histology rather than the cellular material for cytology obtained with EUS-FNA. Furthermore, histology may generally increase the diagnostic yield of EUS-FNA compared to cytology. It is with these aims in mind that a new type of needle, the fine needle biopsy (EUS-FNB) device was developed to enable core tissue sampling. Since a comparison of these to methods has yet to be made, the aim of this study is to perform a direct comparison of the sampling adequacy and diagnostic yield of the new EUS-FNB needle with the conventional EUS-FNA needle.

Background:

Endoscopic ultrasound (EUS) is a well-established tool for the diagnosis and staging of many gastrointestinal conditions, including but not limited to, malignant and pre-malignant neoplasms of the pancreas, esophagus, rectum, and submucosal tumors developing along the gastrointestinal tract. EUS provides endoscopic video imaging within the lumen of the gastrointestinal tract combined with ultrasound images via a transducer positioned at the tip of the endoscope. This diagnostic ability is enhanced by a biopsy method called fine needle aspiration (FNA). FNA via EUS (EUS-FNA) enables a small needle to be passed into a lesion of interest under ultrasound guidance, obtaining cellular material for cytology analysis. EUS-FNA is currently recommended for the confirmation of locally advanced pancreas adenocarcinoma, for the diagnosis of pancreatic cystic neoplasms and neuroendocrine tumors as well as autoimmune pancreatitis, for the characterization of submucosal tumors of the GI tract, and for the determination of malignant lymph node status in the staging of various cancers.

While EUS-FNA has an impressive technical success rate between 90-95%, the diagnostic accuracy is less robust for mass lesions, and in particular for pancreatic masses, for which the sensitivity and specificity is 75% and 100% respectively, translating into a negative predictive value of only 72%. And in the setting of chronic pancreatitis, a condition that is itself a major risk factor for the development of cancer and in which focal, non-malignant nodules often develop that may mimic tumors, the sensitivity of EUS-FNA may only be 54-74%. The diagnostic accuracy of EUS-FNA is of particular importance for pancreas adenocarcinoma and pancreatic neuroendocrine tumors because the 5-year survival rates are only 5% and 32% respectively. Thus, it is crucial that patients found to have a focal mass lesion have a reliable test that effectively excludes malignancy. Currently, EUS-FNA does not have the necessary negative predictive value in order to do so because the sensitivity of the test is too low. This means that a positive result on FNA confirms malignancy but that a negative result is unable to exclude it with confidence. This conundrum tends to leave the patient in the unfortunate position of having to often return for multiple investigations to perform repeat EUS-FNA when the clinical suspicion for a mass lesion remains high but the cytology result is thought to be falsely negative.

In order to overcome the current limitations of EUS-FNA cytology, the new EchoTip® ProCore™ fine needle biopsy (FNB) needle was developed in order obtain core tissue samples for both histology and cytology. This is important because histology is expected to increase the diagnostic yield of EUS-guided biopsy compared to cytology. In addition, in certain clinical circumstances it is more desirable and sometimes necessary to obtain a core tissue biopsy for histology rather than cellular material for cytology obtained with EUS-FNA.

In addition to the assessment of mass lesions in the pancreas, there are several other clinical areas in which the acquisition of core tissue samples for histology may prove superior to cytology from conventional EUS-FNA. For instance, EUS is part of the standard-of-care for the staging of esophageal cancer and histology may improve the sensitivity of EUS-biopsies for the determination of lymph node metastases. Also, although EUS is the preferred method for the work-up of submucosal lesions in the gastrointestinal tract, the value of EUS-FNA for differentiating the various subtypes of lesions is often limited, typically because FNA provides insufficient cellular material to reliably do so. Finally, it is clear that cytology from EUS-FNA is inadequate for the diagnosis of autoimmune pancreatitis and that a core biopsy sample for histology is needed. We expect the new EchoTip® ProCore™ FNB needle to potentially prove superior to FNA in all of these areas.

Study Objectives The purpose of this study is to determine if the new EchoTip® ProCore™ needle (FNB for histology) is superior to the current standard EchoTip® Ultra™ needle (FNA for cytology) for the diagnosis of focal, solid lesions for which biopsy sampling during EUS is clinically indicated. In particular, the objective is to compare the sampling adequacy of FNB with that of FNA for solid mass lesions within the pancreas, for submucosal lesions in the gastrointestinal tract and for the malignant status of lymph nodes as part of esophageal cancer staging. The sampling adequacy will be determined according to the ability of the pathologist to provide a definitive diagnostic interpretation based on the sample provided.

Study Design This is a prospective, comparative trial examining the use of the new EchoTip® ProCore™ FNB needle with the existing EchoTip® Ultra™ FNA needle stratified by lesion type (solid pancreas lesion, intra-abdominal mass, submucosal tumor, suspected metastatic lymph node). Both the FNB and FNA needle will be used in each lesion with randomization to needle type for first pass, alternating subsequent passes; thus each lesion will serve as its own internal control.

Methods Consecutive patients referred for EUS assessment of a solid lesion requiring FNA will be approached regarding study enrollment. Only those patients for whom EUS-FNA is clinically necessary will be selected. Consenting patients will undergo the standard EUS examination as indicated based on their lesion subtype, which will not differ from the EUS exam they would receive if they choose to not participate. Participating patients who have a lesion visualized during EUS that is technically amenable to FNA will then have their lesion biopsied by both FNB and FNA needles. The choice of needle size (19g or 22g) will be left to the clinical discretion of the endoscopist. However, the same needle size must be used for both the FNB and FNA needles.

Patients will be randomized to the type of needle used for the first pass into the lesion, with subsequent passes alternating between needle types. For the EchoTip® ProCore™ FNB needle, if a good sample is obtained (as assessed by the endoscopist performing the EUS examination) with the first pass, no further passes will be made. If the sample obtained with the first pass is considered likely insufficient or if no tissue was acquired, a second pass will then be performed. Regardless of what is obtained after the second needle pass, no additional passes will be made using the FNB. The core tissue obtained by the FNB needle will be placed in formalin and sent for histology analysis.

For the conventional EchoTip® Ultra™ FNA needle, a minimum of 2 passes will be performed. In cases in which a cytotechnologist is present, no feedback will be given to the endoscopist until after the 2nd pass. In cases where no cytotechnologist is present, up to 4 separate passes will be made, or fewer if the endoscopist is satisfied with the sample obtained. The sample obtained with the FNA needle will be placed on slides and also in cytology media (according to our standard clinical protocols).

The histology and cytology specimens will be sent to the pathology department at each site where the interpretation of samples will be done in the usual fashion as per standard clinical care. The pathologist will first describe the biopsy specimen in terms of the "adequacy of the sample for pathologist interpretation" - i.e. the ability of the pathologist to provide a definitive diagnostic interpretation based on the sample provided. Next, the pathologist will provide the diagnostic interpretation itself.

EUS-guided Fine Needle Biopsy With a New Core Histology Needle Versus Conventional Fine Needle Aspiration

Endoscopic Ultrasound Guided Fine Needle Biopsy With a New Core Histology Needle Versus Conventional Fine Needle Aspiration.

The ability of the pathologist to provide a definitive diagnostic interpretation (definitely positive, definitely negative or indeterminate reading) based on the tissue provided for a given lesion of interest.

The sampling adequacy as defined in the primary outcome measure stratified by lesion subtype (pancreas, other intra-abdominal mass, liver mass, submucosal tumor, lymph node)

The diagnosis obtained by FNA or FNB needle compared to the final diagnosis made by either FNA or FNB needle, subsequent surgery, or expert consensus at the end of the data collection period

The diagnosis obtained by the FNA or FNB needle compared to the final diagnosis obtained by either FNA or FNB needle, subsequent surgery or expert consensus regarding clinical diagnosis at the end of the data collection period.

The measure of agreement between diagnoses obtained by FNA and FNB needles for assessment of metastatic lymph nodes

Any adverse events including bleeding, fever, infection, pancreatitis, EUS-induced perforation, and sedation related complications occurring after both FNA and FNB biopsies.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of a New EUS Guided Biopsy Needle (SharkCore) Comparing to Standard EUS Needle (ProCore)	NCT02766842	Mesenchymal Tum... Autoimmune Panc... Lymphoma Solid Tumors	EUS-FNB with Pr... EUS-FNB with Sh... ProCore needle SharkCore needl...	18 Years - 100 Years	Johns Hopkins University
EUS-guided Fine Needle Biopsy With a New Core Histology Needle Versus Conventional Fine Needle Aspiration	NCT01774162	Pancreas Adenoc... Pancreas Neopla... Gastrointestina... Lymphoma	Fine needle bio... Fine needle asp...	18 Years -	University of Alberta
EUS-guided Fine Needle Biopsy With a New Core Histology Needle Versus Conventional Fine Needle Aspiration	NCT01774162	Pancreas Adenoc... Pancreas Neopla... Gastrointestina... Lymphoma	Fine needle bio... Fine needle asp...	18 Years -	University of Alberta

Spots Global Cancer Trial Database for procore

Every month we try and update this database with for procore cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for procore

Every month we try and update this database with for procore cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for procore cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.