Clinical trial NCT05249075: Micro-Tech FNB Needle to Obtain Tissue Specimens of Pancreas Malignancy for Personalized Based Chemotherapy
Official title: Micro-Tech FNB Needle to Obtain Tissue Specimens of Pancreas Malignancy for Personalized Based Chemotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Cancer
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Each patient with clinical suspicion of pancreatic cancer, based on imaging, will be discussed in the multidisciplinary team consultation. When an EUS-FNB is indicated, patients are included if they meet all the inclusion and none of the exclusion criteria.

The population will consist of elderly patients, as pancreatic cancer is rarely diagnosed before the age of 55.

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.

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

Primary outcomes:
measure: Diagnostic accuracy of the Micro-Tech FNB needle in obtaining pancreatic malignancy
timeFrame: 2 years
Secondary outcomes:
measure: Ability to perform genetic sequencing on the sample
timeFrame: 2 years
measure: Puncture success rate
timeFrame: 2 years
measure: User experience
timeFrame: 2 years
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Erwin van Geenen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: