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

NCT ID: NCT05249075

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2025-12-01

Brief Summary

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.

Detailed Description

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.

Conditions

Pancreatic Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erwin van Geenen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Radboudumc

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

112922

Identifier Type: -

Identifier Source: org_study_id