No registrations found.
ID
Source
Brief title
Health condition
Pancreatic Cancer
Periampullary Cancer
Pancreas kanker
Periampullaire kanker
Sponsors and support
Department of Surgery and department of Pathology
Intervention
Outcome measures
Primary outcome
Diagnostic accuracy of NGS
Secondary outcome
- Contribution of NGS to the diagnostic process.
- Percentage of change of treatment type
- Sensitivity and specificity
Background summary
Determination of the added value of Targeted Next-Generation Sequencing in the diagnostic process of patients with a suspect lesion in or around the pancreas, whose morphological assessment of the preoperative cytology sample is benign or inconclusive.
Study objective
Targeted Next Generation Sequencing (NGS) can distinguish benign pancreatic diseases, such as pancreatitis, from pancreatic malignancies during the diagnostic proces of patients with an uncertain diagnosis and treatment plan.
Study design
After patient inclusion is complete
Intervention
The cytology material, obtained during fine-needle aspiration or brush, is analyzed with NGS, the molecular findings are integrated during the diagnostic process.
Inclusion criteria
• Patient with suspect pancreatic or periampullary lesion (papil; duodenum; distal bile duct); or patients with suspect cysts
• Sufficient radiological images; assessed by specialized radiologist
• Sufficient clinical assessment; including bilirubine levels and CA19.9 levels
• Cytology sample available for pathological assessment; either obtained with FNA, brush or punction from cystic wall
Exclusion criteria
none
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6819 |
| NTR-old | NTR7006 |
| Other | Protocolnummer METC : P17.213 |
Summary results
https://www.ncbi.nlm.nih.gov/pubmed/28775172