Micro-Tech FNB Needle To Obtain Tissue Specimens Of Pancreas Malignancy For Personalized Based Chemotherapy

Study Overview

Micro-Tech FNB Needle to Obtain Tissue Specimens of Pancreas Malignancy for Personalized Based Chemotherapy

Systemic chemotherapy can improve disease-related symptoms and/or prolong survival in patients with pancreatic cancer. Before the start of chemotherapy, the diagnosis pancreatic carcinoma must be confirmed by tumor tissue samples, which are often obtained during endoscopic ultrasound (EUS) by fine needle aspiration (FNA) or fine needle biopsy (FNB). Obtaining core biopsies by FNB has several potential benefits, such as making a more reliable diagnosis, performing immunohistochemistry for diagnostic reasons and in the future obtaining enough malignant cells to deliver personalized based chemotherapy regimen based on mutations detected by next generation sequencing. Obtaining high quality and sufficient tumor material is essential for genomic profiling with a preference of FNB over FNA. Up to now, no specific FNB needle has been found to be superior in diagnostic accuracy and in obtaining tissue for genomic profiling. In this study, we aim to evaluate the diagnostic accuracy of a new FNB needle (Micro-Tech Europe GmbH, Düsseldorf, Germany) and we study the adequacy of the obtained tissue samples for performing genetic sequencing.

This study is an international multicenter prospective cohort study. The study will be performed in collaboration with the disciplines of Gastroenterology and Pathology of the participating hospitals.

Pancreatic Cancer

112922

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-02-10	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-08-15
First Submitted that Met QC Criteria 2022-02-10	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-08-21
First Posted (ACTUAL) 2022-02-21	Results First Posted N/A	Last Verified 2025-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Diagnostic accuracy of the Micro-Tech FNB needle in obtaining pancreatic malignancy	Pathologist scores the obtained specimen according the Bethesda system. Diagnostic accuracy will be quantified by the sensitivity and specificity and expressed as frequency of pancreatic malignancy as confirmed by histological evaluation.	2 years

Secondary Outcome Measures	Measure Description	Time Frame
Ability to perform genetic sequencing on the sample	Pathologist will analyze the obtained specimen and determines the size and tumor cellularity. The specimen is deemed sufficient for performing genetic sequencing when tumor cellularity is >20% and the surface is >5mm2. At this stage, no genetic sequencing will be performed	2 years
Puncture success rate	Puncture is successful if the pathologist is able to make a diagnosis on the obtained specimen. By putting each biopsy in a different formalin jar, we can count how many biopsies are needed to be taken to obtain a representative biopsy for diagnosis.	2 years
User experience	User experience of performing FNB with this needle scored with a questionnaire filled in by each participating gastroenterologist after performing all procedures.	2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

18 years and older
Clinical suspicion of pancreatic adenocarcinoma
Indication for obtaining EUS-guided histology of a suspected pancreatic lesion
Written informed consent

Contra-indications to undergoing an EUS (e.g., oropharyngeal abnormalities)
Altered anatomy (e.g., after previous Whipple-operation, Roux-and-Y gastrojejunostomy)
Contra-indications to the administration of benzodiazepines, propophol or opioids
Pregnancy
Insufficient knowledge of the Dutch language to be able to understand the patient information

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Erwin van Geenen, MD, PhD, Radboud University Medical Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record