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.
Study Type
OBSERVATIONAL
Enrollment
138
Radboudumc
Nijmegen, Gelderland, Netherlands
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.
Time frame: 2 years
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
Time frame: 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.
Time frame: 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.
Time frame: 2 years
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