Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Blood and Lymph Conditions

Symptoms and General Pathology

Rare Diseases

Pancreatic Neoplasms

Adenoma

Lymphadenopathy

Cysts

Pancreatic Cyst

Adenoma, Islet Cell

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Lymphatic Diseases

Pancreatic Cancer

Pancreatic Neuroendocrine Tumor

Pancreatic Adenoma

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

Patient indicated for a first endoscopic ultrasound fine needle aspiration (EUS-FNA) for a pancreatic cyst,

Device: nCLE needle-based Confocal Laser Endomicroscopy

Endoscopic ultrasound fine needle aspiration

Divyesh V Sejpal, MD

This study focuses on four different lesions: pancreatic cysts, lymph nodes near the gastrointestinal tract, pancreatic masses and GIST tumors.

On one hand, the results obtained during previous studies are more advanced for the assessment of the diagnostic performance of Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system for Pancreatic cysts. Safety and technical feasibility have already been performed, and an interpretation criteria classification exists. On the other hand, results for pancreatic masses, Lymph nodes and GIST are less developed.

the objectives of the study are to

* Assess the diagnostic performance of the Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system in diagnosing masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract
* Define/Validate descriptive criteria of nCLE sequences in masses and cystic tu-mors of the pancreas, lymph nodes, submucosal lesions of the GI tract

The principle of needle-based Confocal Laser Endomicroscopy (nCLE) is to image organs within or adjacent to the GI or respiratory tracts by means of a miniprobe inserted through an endoscopic needle. The fundamental technology, as well as the principle of operation of nCLE, is substantially similar to pCLE.

endoscopic fine needles are used during EUS-FNA procedures to puncture solid organs such as the pancreas, in order to get tissue or fluid for diagnostic purposes. There are different calibers of endoscopic nee-dles used. The most commonly used calibers for EUS-FNA procedures are 22G, 19G, and 25G needles. The nCLE Confocal Miniprobe is compatible with the 19G-type needle only. It is expected to help to differentiate the different types of lesions, especially for cysts, leading to better patient management. Microscopic tissue information in real-time in vivo during an EUS-FNA procedure may allow better differentiation between mucinous and non-mucinous cysts for instance.

Clinical Registry of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract

Registry Trial for Clinical Evaluation of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract

* Assess the diagnostic performance of the Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system in diagnosing masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract (accuracy evaluation)
* Define/Validate descriptive criteria for nCLE sequences in the characterization of masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract (image interpretation criteria definition

* Evaluate the feasibility and safety of nCLE for the characterization of masses and cystic tumors of the pan-creas, lymph nodes, submucosal lesions of the GI tract (IE. number of patients with complications, number of adverse events)
* Build an atlas of images of nCLE sequences of masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract

Mauna Kea Technologies

EUSFNA using needle without sideport (NA-220H-8022)

EUSFNA using needle with sideport (NA-230H-8020)

Needle with sideport (NA-230H-8020)

Needle without sideport (NA-220H-8022)

Tiing Leong Ang, MD

Background: EUS-guided fine needle aspiration (EUSFNA) is a well established technique for tissue acquisition and diagnosis with excellent safety profile. The overall diagnostic yield of EUSFNA exceeds 80%, with higher rates in EUSFNA of lymph nodes, where rates of \>90% may be expected, as compared to pancreatic masses, where lower diagnostic rates were reported. To maximize the diagnostic yield, at least 3 needle passes are required for lymph nodes and at least 4 passes for pancreatic masses. Olympus has recently made commercially available a new 22 gauge FNA needle (EZ Shot 2 with side port) with a side port at the needle tip. The theoretical basis for introduction of the side port is to increase the diagnostic yield. Preliminary unpublished retrospective data suggested the yield might be raised. However, there are no prospective multicenter randomized controlled studies to ascertain the validity of the assumption.

Aim: To determine whether there is a difference in diagnostic yield between EZ-Shot 2 and EZ-Shot 2 with side port in patients with pancreatic masses for evaluation.

Methods: Patients with pancreatic masses referred for EUSFNA will be recruited prospectively and randomized to either EZ-Shot 2 or EZ Shot 2 with sideport for the first puncture, and then the alternative needle will be used for repeated punctured. The cytological and diagnostic yield at first pass for both needles will be compared.

Clinical significance: This will determine whether the new needle design can further improve the diagnostic yield of EUSFNA of pancreatic masses.

Background Endoscopic ultrasound (EUS) and EUS-guided fine needle aspiration (EUSFNA) are well established techniques in clinical practice. In routine gastrointestinal endoscopy such as gastroscopy, only the mucosal layer of the digestive tract is visualized. In the case of EUS, an ultrasonic transducer located at the tip of the echoendoscope allows the endoscopist to visualize the wall of gastrointestinal tract as a series of definable layers corresponding to histology, rather than as a single entity, and also enables detailed images of areas outside of the digestive tract, such as intra-abdominal lymph nodes, and solid organs such as liver, pancreas to be seen. EUS has a significant clinical impact because it allows assessment of submucosal GI lesions, loco-regional staging of gastrointestinal malignancy, tissue diagnosis by EUSFNA and staging of pancreaticobiliary lesions, non-small-cell lung carcinoma, and mediastinal disease. EUSFNA is a minimally invasive technique of tissue acquisition under EUS guidance. A FNA needle is inserted through the accessory channel of a curvilinear echoendoscope. Both the target lesion and the needle tip are visualized under real time ultrasound guidance, and any potential intervening vessels can be excluded by turning on the Doppler mode prior to needle puncture. The lesion is then punctured under real-time ultrasonic guidance and material aspirated by the needle for cytological assessment.

In prospective trials, EUSFNA has been clearly established to be an important diagnostic tool, with excellent safety profile. The overall diagnostic yield of EUSFNA should exceed 80%, with higher rates in EUSFNA of lymph nodes, where rates of \>90% may be expected, as compared to pancreatic masses, where lower diagnostic rates were reported. The somewhat lower rates for solid pancreatic lesions compared to lymph nodes could be due to the underlying desmoplastic changes associated with pancreatic malignancies.

EUSFNA may be performed with rapid on site cytopathological assessment (ROSE) of the aspirated material to guide the number of needle passes being performed. In most practices, rapid on site cytopathological assessment is not feasible and it has been recommended that in such situation, in order to maximize the diagnostic yield, at least 3 needle passes should be performed for lymph nodes and at least 4 passes should be performed for pancreatic masses. Even without onsite cytopathological assessment, excellent results with greater than 90% diagnostic yield have been reported by expert centers.

Needles for EUSFNA are available from four manufacturers, namely Cook Endoscopy, Boston Scientific, Olympus Corporation and Mediglobe. The available needle diameters are 25, 22 and 19 gauge. These needles have a sharp tip for puncturing and a hollow core for aspiration after the puncture. The hollow needle core is covered by a stylet which is withdrawn after the puncture to facilitate aspiration. Aspiration is usually facilitated by application of suction using a syringe which is attached to the entry port of the hollow core of the needle, after the stylet has been withdrawn, although it must also be acknowledged that there are endoscopists who prefer to apply no suction in order to reduce the possibility of bloody aspirates. Olympus has recently made commercially available a new 22 gauge FNA needle with a side port at the needle tip. The theoretical basis for introduction of the side port is to facilitate the process of fine needle aspiration, and to increase the diagnostic yield. There have been preliminary unpublished retrospective data that suggested the yield might be raised. However, there are no prospective multicenter randomized controlled studies to ascertain the validity of the assumption. Currently two needles with similar designs, apart from absence and presence of side port, are available from Olympus Corporation. These are the EZ-Shot 2 (model: NA-220H-8022) and EZ-Shot 2 with side port (NA-230H-8022)

Aim The aim of this prospective randomized study is to determine whether there is a difference in diagnostic yield between EZ-Shot 2 (model: NA-220H-8022) and EZ-Shot 2 with side port (NA-230H-8022) in patients with pancreatic masses for evaluation.

Materials and methods

1. Setting and trial design:

   Setting: International; multicenter. Trial design: Randomized prospective comparative study.
2. Subjects:

   Inclusion criteria: 1) all patients referred for EUSFNA of pancreatic masses; 2) informed consent is obtained for performance of EUSFNA.

   Exclusion criteria: 1) presence of active gastrointestinal bleeding; 2) presence of coagulopathy as defined by platelet count \<50000/mm3 or/ and international normalized ratio \>1.5; 3) the current use of thienopyridines (e. g. clopidogrel) in patents requiring anti-platelet therapy; 4) absence of procedural informed consent.
3. Informed Consent:

   The protocol will be approved by local Institutional Review Board. Patients will be giving informed consent for the procedure.
4. Interventions:

   Randomization: Randomization of the needle used for initial puncture will be carried in blocks of 5 with equal assignment to the EZ-Shot 2 (model: NA-220H-8022) and EZ-Shot 2 with side port (NA-230H-8022) needles. Once the first 2 punctures have been performed, the alternative needle will be used to obtain the subsequent needle passes.

   EUS and EUSFNA technique: EUS and EUS will be performed using a curvilinear echoendoscope according to standard techniques9 by a credentialed endoscopist or under the direct supervision of a credentialed endoscopist in the case of procedures performed by trainees. The patient will either undergo the procedure without sedation, under sedation or under general anesthesia as clinically indicated. As per standard technique, the lesion is visualized using EUS, and then the 22gauge EUSFNA needle (depending on randomization either NA-220H-8022 or NA-230H-8022) is introduced into the accessory channel of the echoendoscope and the lesion is punctured under real time ultrasonic guidance. After withdrawal of the stylet and application of suction by attachment of a syringe with negative pressure, the needle is moved to and fro within the lesion for approximately 30 seconds, and then the needle is withdrawn and the material aspirated is expressed onto glass slides by reinsertion of the stylet and direct smears are made either by the endoscopist or cytotechnician. This process is repeated once using the first needle. The alternative needle is then used to make 2 further punctures..

   Preparation of aspirated material and definition of cellular adequacy and diagnostic yield10,11: The material aspirated is expressed onto glass slides by reinsertion of the stylet and direct smears are made either by the endoscopist or cytotechnician. After expressing the cellular material onto glass slides, half the slides will be air-dried and half will be alcohol fixed (95% ethanol) for subsequent cytological assessment. When no further material can be expressed, the residual contents of the needle are flushed with 5 to 10 mL of sterile saline solution into a balanced salt solution. After flushing the needle, the outside of the needle and the stylet are vigorously wiped with saline solution-soaked sterile gauze to reduce cross contamination between passes.

   An adequate specimen is defined as the clear presence of target organ cells. In the case for the pancreas there must be at least 4 clusters of pancreatic acinar cells with or without the presence of malignant-appearing cells. A cytopathologist blinded to the needle used for FNA, will characterized each individual needle pass for assessment of adequate cellularity (0 \[inadequate\] or 1 \[adequate\]) and a diagnosis of malignancy (insufficient, normal, "suspicious," malignant). . The diagnosis arrived at for each needle pass will be compared with the final diagnosis which will be based on composite of cytology, histology and clinical course. The EUSFNA findings will be classified as 1) inadequate for diagnosis; 2) true positive for malignancy; 3) true negative for malignancy; 4) false positive for malignancy; 5) false negative for malignancy.
5. Statistics Sample size: As this is an exploratory study, a sequential trial design will be used to determine the ideal sample size. For the initial assessment, a total of 30 pancreatic masses will be targeted. Dependent on the outcome and trend, this may be further increased to 100 cases.

   Outcome variables:

   Primary 1. Compare 1st pass cellular adequacy rate each needle: 2. Compare the overall cellular adequacy rate each needle 3. Compare the overall diagnostic accuracy rate between both needles 4. Compare 1st pass diagnostic accuracy adequacy rate of each needle
6. Timetable of work Complete study within 6 months, but may extend to 24 months

RCT: Difference in Diagnostic Yield Between EUSFNA Needles With and Without a Side Port in Pancreatic Masses

A Prospective Multi-center Randomized Study of the Difference in Diagnostic Yield Between EUSFNA Needles With and Without a Side Port in Pancreatic Masses

Compare the overall diagnostic accuracy rate between both needles

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clinical Registry of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract	NCT01770405	Pancreatic Cyst Pancreatic Neop... Pancreatic Aden... Pancreatic Canc... Pancreatic Isle... Lymph Node Mass Lymphadenopathy GIST	Endoscopic ultr...	18 Years -	Mauna Kea Technologies
RCT: Difference in Diagnostic Yield Between EUSFNA Needles With and Without a Side Port in Pancreatic Masses	NCT02092519	Pancreatic Neop... Pancreatic Dise...	Needle with sid... Needle without ...	21 Years -	Changi General Hospital

Spots Global Cancer Trial Database for eusfna

Every month we try and update this database with for eusfna 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 eusfna

Every month we try and update this database with for eusfna 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 eusfna 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.