In short
There is currently 1 ongoing clinical trial investigating diagnostic techniques for intraductal papillary mucinous neoplasm (IPMN). This trial is comparing different methods of collecting and analyzing pancreatic samples to detect genetic changes that may help understand the risk of progression to pancreatic cancer. (Also known as: IPMN)
Clinical trial locations
Study Comparing Secretin Synthetic Human and Endoscopic Aspiration Techniques for Analyzing Pancreatic Cancer in Patients with Intraductal Papillary Mucinous Neoplasia
This trial is being conducted in Spain and focuses on improving the diagnosis and monitoring of IPMN, a condition where cystic tumors grow in the pancreatic ducts. These growths can sometimes develop into pancreatic cancer over time, so detecting genetic changes early is important for patient care.
Main focus of the trial: The study compares two different techniques for collecting samples from the pancreas to detect specific genetic mutations in the GNAS and KRAS genes. These mutations can provide important information about the nature and risk of the condition. The two methods being tested are ADPJ-secr, which collects pancreatic juice after stimulating the pancreas with a medication called Chirhostim (containing secretin), and EUS-FNA, which uses a needle guided by ultrasound to take samples directly from the pancreas.
Investigational approach: The trial uses secretin synthetic human (contained in Chirhostim), which is a hormone that stimulates the pancreas to produce digestive juices. This medication is given through an intravenous infusion to help collect pancreatic fluid for analysis. Additionally, the endoscopic ultrasound-guided fine needle aspiration technique is used to obtain tissue samples for molecular testing.
Who can participate: The trial is open to men and women over 18 years of age who have been diagnosed with IPMN based on imaging findings from MRI or endoscopic ultrasound. Participants should have cysts that are 10 mm or larger, or dilation of the main pancreatic duct of 7 mm or larger. Those requiring surgical removal of their lesion may also be eligible. Women of childbearing potential must agree to use effective contraception and take a pregnancy test before joining the study. Participants must be willing to follow study procedures and provide written informed consent.
Who cannot participate: Patients without a confirmed diagnosis of IPMN or pancreatic cancer are not eligible. Those who cannot provide informed consent or belong to vulnerable populations may also be excluded from the study.
What happens during the trial: Participants undergo both collection methods in sequence. First, they receive an infusion of Chirhostim to stimulate pancreatic juice production, which is then collected. Next, they undergo the ultrasound-guided needle aspiration procedure. The collected samples are analyzed for genetic mutations and other molecular characteristics. Participants are monitored for any side effects at 24 hours and 7 days after the procedures. If scheduled for pancreatic surgery within 12 months, their findings may be compared with surgical outcomes.
Summary
Currently, there is one active clinical trial for intraductal papillary mucinous neoplasm, located in Spain. This trial focuses on improving diagnostic techniques rather than testing new treatments. The study is particularly interested in comparing sample collection methods to better detect genetic mutations that may indicate cancer risk. The use of secretin to stimulate the pancreas represents an established diagnostic approach being compared with direct tissue sampling methods. This research may help doctors better identify which patients with IPMN are at higher risk of developing pancreatic cancer and require closer monitoring or intervention.
