Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

These patients will undergo endoscopic ultrasound-guided fine needle biopsy using the Franseen needle (Acquire FNB needle; Boston Scientific): eight back and forth movements within the lesion will be performed with simultaneous minimal negative pressure provided by withdrawing the needle stylet slowly. Four passes of FNB will be made from each mass lesion and the specimens from each pass will be placed in different containers for cell block preparation and histologic evaluation.

These patients will undergo endoscopic ultrasound-guided fine needle biopsy using a multi-blade three-prong tip needle (Trident; Microtech): eight back and forth movements within the lesion will be performed with simultaneous minimal negative pressure provided by withdrawing the needle stylet slowly. Four passes of FNB will be made from each mass lesion and the specimens from each pass will be placed in different containers for cell block preparation and histologic evaluation.

Taking biopsy from solid pancreatobiliary mass lesions with 8 back and forth movement of the needle within the lesion with slow withdrawal of the stylet

Fine needle biopsy

EUS-guided tissue acquisition is an established modality to diagnose malignancies of the pancreas and extrahepatic bile ducts. In the recent years fine needle biopsy (FNB) needles have largely replaced fine needle aspiration (FNA) for EUS-guided tissue acquisition. The Acquire FNB needle is a Franseen needle which has three symmetric cutting edges to obtain core tissue specimens. The Trident FNB needle has been recently introduced to the market for EUS-guided tissue acquisition. It has a multi-blade three-prong tip which one of the tips is longer than the other two.

The aim of this study is to prospectively compare these two types of needle in term of diagnostic accuracy, and safety profile.

Patients with solid mass lesions in the pancreas or extrahepatic biliary system will be randomly assigned to one of two types of FNB needle. Four passes of FNB will be acquired from the mass lesion in each patient. The primary aim is to compare sensitivity of two types of FNB needle to diagnose malignancy. Also, each pass of FNB needle will be assessed separately by two expert pathologists to determine per-pass sensitivity of two types of FNB needles.

The pathologists who assess the FNB specimens are blinded on the needle type

Comparison of Two Types of Biopsy Needles for EUS-FNB in Solid Pancreatobiliary Mass Lesions

Comparison of Two Types of Biopsy Needles for Endoscopic Ultrasound-guided Fine Needle Biopsy (EUS-FNB) in Solid Pancreatobiliary Mass Lesions

Comparison of EUS-FNB sensitivity using two types of FNB needles

Comparing per-pass sensitivity in two types of FNB needles

Comparing the adequacy of specimen for each pass in two types of FNB needles

Comparing the rate of core tissue acquisition for each pass in two types of FNB needles

Comparing specimen cellularity for each pass in two types of FNB needles

Comparing the score of blood content n for each pass in two types of FNB needles. (The blood content is scored from 1 to 3 in which 1 represents minimal presence of blood in the specimen).

University of Tehran

Associate professor of medicine

Immune System Diseases

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Gastrointestinal Stromal Tumors

Neuroendocrine Tumors

Pancreatitis

Autoimmune Pancreatitis

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Pancreatitis, Chronic

Autoimmune Diseases

Chronic Disease

Disease Attributes

Neuroendocrine Tumor

Neuroepithelioma

Chronic Graft Versus Host Disease

FNB needles adpted to acquire lesion tissues according patients' advice and patients' willings.

FNA needles adpted to acquire lesion tissues according patients' advice and patients' willings.

Fine-needle-biopsy (Echotip ProCore Needle)

FNB group

FNA group

Endoscopic ultrasound (EUS)-guided fine needles with side fenestrations are used to collect aspirates for cytology analysis and biopsy samples for histologic analysis. The investigators conducted a large, multicenter study to compare the accuracy of diagnosis via specimens collected with fine-needle biopsy (FNB) versus fine-needle aspiration (FNA) for patients with lesions requiring immunohistochemistry (IHC) pathological diagnosis.

Current guidelines recommend FNA and FNB needles equally for pancreatic and other deep-seated lesions. However, some studies indicate that the sample adequacy for histologic evaluation is higher when using FNB compared with FNA needles. The diagnosis of neuroendocrine tumor (NET), autoimmune pancreatitis (AIP), and other gastrointestinal stromal tumors require high-quality tissue sampling for IHC diagnosis. Whether FNB is superior to FNA in these IHC-required lesions remains unclear.

The investigators performed this at 2 tertiary care centers in China. The study prospectively collected patients undergoing EUS for a solid mass (\>1 cm) in the pancreas, abdomen, mediastinum, or pelvic cavity from December 2014 diagnosed with AIP, NET, mesenchymal tumors, and Lymphoma. Patients accepted FNB or FNA according to doctors' and patients' willingness in a real-world setting. All procedures were performed by experienced endosonographers; cytologists and pathologists were blinded to the sample collection method. Patients were followed for at least 48 weeks, and final diagnoses were obtained after surgery, imaging analysis, or resolution of the lesion. The primary aim was to compare diagnostic yields of EUS-FNA with EUS-FNB for all solid masses, then separately as AIP, NET, mesenchymal tumors, and lymphoma. The secondary endpoint was the quality of the histologic specimen.

A Real-world Comparison of FNB and FNA in IHC-required Lesions.

A Real-world Comparison of FNB and FNA in IHC-required Lesions: A Prospective, Multicenter Study.

Overall dignostic yields of all solid lesions

Specimen adequacy - whether adequate for IHC staining

Peking Union Medical College

Huazhong University of Science and Technology

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Liver Diseases

Hematinics

All Drugs and Chemicals

Liver Extracts

EUS-LB will be performed using a 22 g FNB needle. Specimens obtained from each pass will be placed in a separate biopsy jar. If the third pass does not result in sufficient diagnostic material, a 19 G will be used. A maximum of 3 passes will be made using the alternate needle. The total number of passes with the 22 G needle and the 19 G needle is 6. Data will be collected about the procedure and the performance of the needles for each procedure.

EUS will be performed. Specimens obtained from each pass will be placed in a separate biopsy jar. If the third pass does not result in sufficient diagnostic material, a 19 G will be used. A maximum of 3 passes will be made using the alternate needle. The total number of passes with the 22 G needle and the 19 G needle is 6. Data will be collected about the procedure and the performance of the needles for each procedure.

22 gauge needle liver biopsy

Muhammad Hasan, MD

This is a prospective study to determine the optimal technique for obtaining liver tissue with a smaller caliber (22 gauge) needle and whether a good core biopsy can be obtained without the use of suction and secondly to determine the diagnostic yield and safety of 22 g Fine Needle Biopsy needle for liver biopsy.

Liver biopsy (LB) has historically been performed by percutaneous route without image guidance (blind biopsy). However, in the last several years there has been more reliance on image guidance ultrasound-guided (USG) or computed tomography (CT) to direct the needle into the liver with the hope of limiting complications. Other ways of performing liver biopsy are transjugular fluoroscopy guided approach when percutaneous route is deemed not safe because of coagulopathy or ascites. Surgical LB (either laparoscopic or open) is yet another way of obtaining liver tissue.

Endoscopic ultrasound guided liver biopsy (EUS-LB) is proposed as a newer method that may offer several potential advantages over existing techniques for attaining liver tissue. It can be performed in an outpatient setting and offers the comfort of sedation and analgesia. Endoscopic Ultrasound (EUS) provides high resolution images of left lobe of the liver and a good portion of the right lobe of the liver. This coupled with Doppler capability the biopsy needle can be safely directed into the liver for sampling under real time image guidance. Intervening structures such as pleura, bowel loops and gallbladder can be easily seen by EUS and thus avoided that further decreases the risk of adverse events. It has been recognized that sampling error can lead to diagnostic inaccuracy of a biopsy from a single site. As compared to USG or CT scan the EUS allows easy and safe biopsy of both left and right lobes of the liver during same setting, potentially addressing concerns about sampling error.

The cost of the endoscopic procedure is the main expense of EUS-LB. Thus this approach is best used for patients requiring EUS for evaluation of elevated liver tests. If no obstructive lesion is identified by EUS that will require endoscopic retrograde cholangiopancreatography (ERCP) then it would cost-effective to perform EUS-LB during the same setting without much additional time and risks. This approach can spare the patient the additional discomfort and expense of a second dedicated LB procedure by any of the other available techniques (percutaneous, transjugular etc.). In such setting the equipment costs for the EUS-LB will mainly include only the Fine Needle Biopsy (FNB) needle, which is similar in expense to the cost of needles for the transjugular or percutaneous approach.

The traditionally used transcutaneous LB needle is 16 gauge (G) while largest EUS biopsy needle is 19 G. The smaller size of the needle is expected to decrease the complications rate (mainly pain and bleeding) even further. Many studies using a 19 G Tru-cut biopsy or Fine Needle Aspiration (FNA) needle to acquire liver tissue have obtained specimens adequate for histologic diagnosis but there has been a wide range of specimen adequacy (19-100%). The 19 G Tru-cut biopsy needle has been associated with several technical difficulties that could reflect negatively on tissue adequacy.

While it is easy and straight forward to biopsy the left lobe of the liver with any EUS needle. The 19 G needle is a large bore needle for EUS use and it is sometimes difficult to attain an adequate position for biopsy specially in duodenum where scope is torqued and this is the only area of access to right lobe.

In this study the investigators will use a 22 G needle. Smaller caliber of the needle would not only make it technically easier to access right lobe of the liver through the duodenum, it is also expected to decrease the risks further due to smaller size. Also, the 22 G EUS-FNB needle has three cutting points at the cutting edge of the needle that provide stability at puncture while the high quality, fully formed heels are designed to maximize tissue capture and minimize fragmentation, that would result in attaining a good histological specimen, a main stay for liver biopsy.

Endoscopic Ultrasound Guided Liver Biopsy

Endoscopic Ultrasound Guided Liver Biopsy Using a 22 Gauge Fine Needle Biopsy Needle.

There is no plan to share the individual participant data with other researchers.

Determine the diagnostic adequacy of the liver biopsy specimen by obtaining a histological specimen using a smaller (22 G) caliber needle. Diagnostic adequacy is defined as a sample that provides definitive pathological diagnosis (yes, no).

The sample will have a visible core (yes/no).

Sample was obtained using suction (yes/no).

Assessing the median number of passes required to obtain diagnostically adequate histological samples histological samples

Assessing subjects for post-procedural complications via follow up phone calls. Bleeding (yes/no).

Assessing subjects for post-procedural complications via follow up phone calls. Pain (yes/no).

Assessing subjects for post-procedural complications via follow up phone calls. Infection (yes/no).

AdventHealth

ProControl, MediGlobe

TopGain, Medi-Globe

Bojan Kovacevic

Bojan Kovacevic, MD

The aim of this study is to compare tissue quality and molecular yield between a novel crown-cut biopsy needle (FNB) and a standard aspiration needle (FNA) for EUS-guided diagnosis of solid pancreatic lesions.

Novel Crown-cut Biopsy Needle (FNB) vs Standard Aspiration Needle (FNA) for EUS-guided Diagnosis of SPLs

Randomized Comparison of Tissue Quality and Molecular Yield Between a Novel Crown-cut Biopsy Needle (FNB) and a Standard Aspiration Needle (FNA) for EUS Guided Diagnosis of Solid Pancreatic Lesions

Comparison of median number of tissue micro-fragments

Comparison of total diagnostic tissue area in um2

Comparison of total total tissue area in um2

diagnostic yield - defined by percentage of diagnostic samples in each group

Sensitivity and specificity, where final diagnosis is either established by subsequent histopathological confirmation or other evidence (clinical, radiological) of malignant disease at a minimum of 12 months of follow-up

Comparison of proportions of patients experiencing AE in each group as defined by ASGE's lexicon on adverse events in endoscopy

Percentage of samples where NGS analysis was successful

Gastro Unit, Endoscopy Section, Hvidovre Hospital, Denmark

Department of Gastroenterology, Ponderas Academic Hospital Bucharest, Romania

Endoscopy Unit, Odense Hospital, Denmark

Peter Vilmann MD, DSc, HC, FASGE

Professor

Blood and Lymph Conditions

Lymphoma

Lymphosarcoma

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.

University of Alberta

Assistant Professor

Lymphadenopathy

Lymphatic Diseases

Fine needle aspiration

Srinadh Komanduri

Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has traditionally been done with fine needle aspirate where a needle is inserted into the tumor and potentially malignant cells are extracted for microscopic analysis. More recently, a needle that allows a tissue biopsy for histologic analysis has been FDA approved.

The Echotip Procore (Cook Medical) core biopsy needle (ETP), has been demonstrated to provide excellent efficacy for core biopsy samples. Final diagnostic yield using this needle ranges from 80-90% and appears to be significantly greater than EUS-FNA for lesions requiring histology for diagnosis. However, there is currently only limited data from prospective studies comparing EUS-FNA to EUS-FNB with the ETP needle. The investigators propose a randomized, prospective, cross-over study comparing diagnostic accuracy of EUS-FNA to EUS-FNB.

Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has traditionally been done with fine needle aspirate where a needle is inserted into the tumor and potentially malignant cells are extracted for microscopic analysis. More recently, a needle that allows a tissue biopsy for histologic analysis has been FDA approved.

We will compare tissue samples obtained by standard FNA to FNB with a sample size of 140 patients with the primary outcome being diagnostic yield. Each patient will be randomized to FNA or FNA. If after 3 passes the on-site evaluation remains inadequate, the endoscopist will crossover to the other arm.

Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle

Randomized Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle

The investigators' primary outcome measure will assess the diagnostic yield (percentage of patients with a diagnosis) of EUS-FNB (fine-needle biopsy) to provide a final diagnosis of the lesion being sampled. This will be expressed as a percentage.

The investigators' secondary outcome will assess the ability to obtain an adequate specimen for in room cytologic evaluation as determined by our cytopathologist. This will be defined as a sample that is representative (not necessarily diagnostic) of the lesion in question. This will be expressed as a percentage and compared between FNA and FNB

As above. Crossover to FNA or FNB occurs after 3 passes without adequate material

Northwestern University

Associate Professor of Medicine

Fine needle aspiration: Fine needle aspiration

Fine Needle Aspiration

Fine needle biopsy

Fine needle biopsy: FNB

Fine Needle Biopsy

fine needle aspiration

Fine needle aspiration: Fine needle aspiration

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Diagnostic Yield of EUS-FNB and EUS-FNA

Patients with pancreatic and non-pancreatic lesions receiving EUS-FNA and EUS-FNB.

Specimen Adequacy as Assessed by Rapid-onsite Evaluation of FNA and FNB

fine needle aspiration to fine needle biopsy

EUS-FNA to EUS-FNB

Fine Needle Aspiration to Fine Needle Biopsy

Fine needle biopsy to fine needle aspiration

EUS-FNB to EUS-FNA

Fine Needle Biopsy to Fine Needle Aspiration

Participants receiving alternative tissue acquisition method when initial three passes with either EUS-FNA or EUS-FNB failed to provide an adequate specimen.

Percentage of Patients in Whom a Diagnosis is Achieved After Crossover (%)

fine needle aspiration

Fine needle aspiration: Fine needle aspiration using endoscopic ultrasound-FNA needles. This was the standard of care arm

Fine Needle Aspiration (FNA)

Fine Needle biopsy

Fine Needle biopsy: FNB, test arm for core biopsies, endoscopic ultrasound-FNB

Fine Needle Biopsy (FNB)

Overall Study

Gastrointestinal Agents

Pancrelipase

Pancreatin

Patients with tumors of the pancreas, submucosal tumors or lymphnode disease of the upper gastrointestinal tract, which have to undergo EUS guided FNB.

Endoultrasound guided FNB

Ulrike Denzer, PD. Dr. med.

Alexander Waldthaler, Dr.med.

Ulrike Denzer, PD.Dr.med.

The present study investigates the efficacy of a new Endoultrasound guided fine needle biopsy (EUS-FNB) device (AquireTM Boston Scientific= AQUIRE®) for obtaining histological tissue cylinders in the diagnosis of solid pancreatic tumors, submucosal tumors of the upper gastrointestinal tract (esophagus, stomach, duodenum) and lymph node disease..

The AquireTM FNB device uses a triple point tip that is designed to maximize tissue capture and minimize fragmentation.

The efficiency of the 22 Gauge needle is evaluated in a prospective single arm study. The material obtained will be collected for formalin fixation and analyzed by a pathologist blinded for the type of needle device.

Prospective Evaluation of the Diagnostic Efficacy of a EUS Guided FNB Needle (AQUIRE®)

Prospective Evaluation of the Diagnostic Efficacy of a EUS Guided FNB Needle (AQUIRE®) in Tumors of the Pancreas, Submucosal Tumors and Lymph Node Disease of the Upper GI Tract

The primary outcome of the present study is to analyze the percentage in which a representative histological sample can be obtained by EUS-FNB (quality score 3 as defined by Payne et al.).

Philipps University Marburg Medical Center

Prof. Dr. med. Ulrike Denzer, Head of the department of endoscopy

All patients will undergo sampling of pancreatic masses using the Acquire EUS Biopsy Device. Both needles will be used, but the needle to be used first will be based on randomization. A minimum of at least one pass and a maximum of 8 passes will be performed using both needle types.

All patients will undergo sampling of pancreatic masses using the SharkCore Biopsy System. Both needles will be used, but the needle to be used first will be based on randomization. A minimum of at least one pass and a maximum of 8 passes will be performed using both needle types.

At EUS, once the pancreatic mass is identified, patients will be randomized to undergo sampling using the 22G Acquire EUS Biopsy Device or SharkCore Biopsy System.

Acquire EUS Biopsy Device

SharkCore Biopsy System

Shyam Varadarajulu, MD

This is a randomized prospective clinical study comparing the Acquire Biopsy Device to SharkCore Biopsy Device.

At EUS, once the pancreatic mass is identified, patients will be randomized to undergo sampling using one of the two FNB needle. All patients will undergo sampling of pancreatic masses using both needles but the needle to be used first will be based on randomization. Subsequent passes will be performed by alternate needles and once onsite diagnosis is established using either needle type, more passes will not be performed for onsite diagnostic adequacy. However, a minimum of at least one pass and a maximum of 8 passes will be performed using both needle types. The number of passes needed to achieve diagnostic adequacy using both needles will documented.

Four dedicated passes will then be performed using the initial randomization sequence for cell block. Two passes will be performed using each needle type and the specimen will be preserved in formalin and sent for cell block processing.

If the doctor cannot obtain enough tissue with the study needles, another needle with a different gauge (19 or 25) will be used. This will also be a maximum of 8 passes. Information about the number of needles used, how many passes were performed, any problems with the needles will be collected. If there is not enough tissue available from these passes to establish a diagnosis, the subject will be asked to come back at another time for a repeat procedure.

Comparison of Two Fine Needle Biopsy Needles for Solid Pancreatic Masses

Randomized Trial Comparing Two Fine Needle Biopsy Needles for Endoscopic Ultrasound-guided Sampling of Solid Pancreatic Masses.

The primary objective of this study is to compare the total area of procured tissue between the two FNB needles in patients undergoing EUS-guided sampling of pancreatic masses.

Pancreatic masses sampled using the Acquire Endoscopic Ultrasound Fine Needle Biopsy Device needle should yield a tissue volume greater than the SharkCore Fine Needle Biopsy System needle because the serrated design of the FNB needle tip is expected to procure greater volume of tissue. This will be measured using a specialized digital image analysis software.

This hypothesis will be tested by comparing the total tissue volume, tumor volume within the tissue, stroma volume within the tissue, tumor vs. stroma ratio and the macroscopic length of the procured tissue measured in millimeters. When evaluated together, the above measurement provide the total area of tissue procured.

The secondary objective of this study is to compare the diagnostic adequacy between the two FNB needles in patients undergoing EUS-guided sampling of pancreatic masses.

Pancreatic masses sampled using the Acquire Endoscopic Ultrasound Fine Needle Biopsy Device needle should yield diagnostic adequacy with fewer passes as they are expected to procure a greater area tissue than the SharkCore Fine Needle Biopsy System needle.

This hypothesis will be tested by comparing the number of passes required to establish a onsite diagnosis using both needle types in individual patients.

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

Patients in this arm will undergo the modified wet-suction technique. Details in the study description section. After sufficient sampling of the lesion, the needle will be removed and the specimen will be collected.

Patients in this arm will undergo the Capillary "slow pull" technique which will include moving the needle to-and-fro into the lesion. Subsequently the needle will be removed and the specimen will be collected.

Normal saline will be present in this needle, and once in the lesion of interest the suction will be re-established and the needle will be moved in a to-and-fro motion to collect the sample of interest. Then the sample will be collected.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Two Types of Biopsy Needles for EUS-FNB in Solid Pancreatobiliary Mass Lesions	NCT04975620	Pancreatic Neop...	Fine needle bio...	18 Years -	University of Tehran
A Real-world Comparison of FNB and FNA in IHC-required Lesions.	NCT05565066	Neuroendocrine ... Autoimmune Panc... Gastrointestina...	FNB group FNA group	18 Years -	Huazhong University of Science and Technology
Endoscopic Ultrasound Guided Liver Biopsy	NCT03307811	Hepatic Cancer Hepatic Neoplas... Hepatic Carcino...	22 gauge needle...	19 Years -	AdventHealth
Novel Crown-cut Biopsy Needle (FNB) vs Standard Aspiration Needle (FNA) for EUS-guided Diagnosis of SPLs	NCT04687410	Pancreas Neopla... Pancreas Cancer	ProControl, Med... TopGain, Medi-G...	18 Years -	Herlev Hospital
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
Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle	NCT01769248	Pancreatic Canc... Lymphadenopathy Gastrointestina...	Fine needle asp... Fine needle bio...	18 Years - 90 Years	Northwestern University
Prospective Evaluation of the Diagnostic Efficacy of a EUS Guided FNB Needle (AQUIRE®)	NCT03621852	Tumors of the P... Submucosal Tumo... Lymph Node Dise...	Endoultrasound ...	18 Years - 85 Years	Philipps University Marburg Medical Center
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
Comparison of Two Fine Needle Biopsy Needles for Solid Pancreatic Masses	NCT02910960	Pancreatic Neop...	Acquire EUS Bio... SharkCore Biops...	18 Years -	AdventHealth
Modified Wet Suction Versus Capillary Techniques for EUS Guided Fine Needle Aspiration and Biopsy of Solid Lesions	NCT02919553	Pancreatic Canc... Stomach Neoplas...	modified wet-su... Capillary "slow...	18 Years -	Loma Linda University
Comparing Biopsy Needles for Endoscopic Ultrasound Guided Samples for Pancreatic Masses	NCT02911974	Pancreatic Neop...	Acquire EUS Bio... Expect EUS Aspi...	18 Years -	AdventHealth

Spots Global Cancer Trial Database for fine needle biopsy