The Use of a New Core Needle in the Endoscopic Ultrasound Assisted Tissue Sampling for Pancreatic Solid Masses

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) is a reliable, safe, and effective technique for obtaining samples from pancreatic masses. A new core biopsy needle has been developed by Beacon bnx® (Medtronic, Newton, MA) that allows the possibility to achieve a core for histology evaluation and the interchangibility of needle size using the same needle shelter and different needle sizes.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Clinical Trial With a New Needle Device Comparing Two Needles for EUS_FNA of Solid Lesions.

NCT02246322

Pancreatic Cancer Neuroendocrine Tumors Lymphadenopathies +2 more

UNKNOWN NA

Diagnostic Yield of 20-gauge Procore Needle for EUS-guided FNA Biopsy in Solid Pancreatic Lesions

NCT02920944

Pancreatic Neoplasms

COMPLETED NA

Comparing Methods to Biopsy Pancreas Mass

NCT01663493

Pancreas Mass Diagnosis

COMPLETED NA

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

NCT04975620

Pancreatic Neoplasms

COMPLETED NA

EUS-FNB for Solid Pancreatic Lesions: Side-fenestrated Vs Fork-tip Needle

NCT03622229

Biopsy, Fine-needle Pancreatic Neoplasm

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

At every pass, the material will be fixed in formalin. Three passes will be done. Details of the aspirated material will be described at macroscopic evaluation by the endoscopist and then by the pathologist at macroscopic and microscopic evaluation, in order to find an interobserved agreement on the definition of the core.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatic Masses

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Solid pancreatic masses

Consecutive patients with solid pancreatic masses, submitted to FNA with 25 G Beacon needle (Medtronic, Newton, MA, USA)

FNA with 25 G Beacon needle

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FNA with 25 G Beacon needle

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age greater than 18 and less than 90, both genders..
* Presence of a pancreatic solid lesion. In the presence of a cystic component, the solid part of the lesion should be more 75% of the total.
* Absence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma or coagulation factors.
* Informed consent is obtained.

Exclusion Criteria

* Previous biopsy of the lesion with diagnosis of malignancy
* Presence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.
* Pregnancy or breast-feeding.
* Patients unable to understand and/or read the consent form.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No