Diagnostic yield of Endoscopic aspiration of duodenopancreatic juice after secretin stimulation (ADPJ-secr-) vs endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for molecular analysis of intraductal papillary mucinous intraductal neoplasia (IPMN)
This research is looking at two different methods for collecting fluid from the pancreas. One method uses a thin, flexible tube (endoscope) to take fluid directly after a special injection, while the other uses an ultrasound-guided needle. The main goal is to find out which of these two methods is more effective at detecting particular gene changes, called GNAS and KRAS mutations, in people who have a condition called IPMN (Intraductal Papillary Mucinous Neoplasia) in their pancreas. Finding these gene changes can be important for understanding and managing this condition. The study also looks at how easy it is to get good quality samples for testing using each method.
At a glance
What is this study about?
This study is designed to help doctors better understand and diagnose certain conditions in the pancreas. The pancreas is a gland located behind your stomach that helps with digestion and blood sugar control. Sometimes, harmless growths called IPMNs (Intraductal Papillary Mucinous Neoplasia) can form in the pancreas, but some of these can eventually turn into cancer. Early and accurate information about these growths is very important.
Researchers are comparing two ways to collect fluid from the pancreas. One method, called ADPJ-secr, involves stimulating the pancreas with a special medicine called Chirhostim to make it produce fluid, which is then collected using an endoscope (a thin, flexible tube with a camera). The other method, called EUS-FNA, uses an ultrasound to guide a very fine needle to collect fluid. The main aim is to see which of these two methods is better at finding specific small changes in genes, such as GNAS and KRAS mutations, within the fluid samples.
Finding these gene changes can provide important clues about the nature of the IPMN and help doctors decide on the best treatment. The study also looks at how much DNA can be collected and how easily the samples can be used for detailed testing. By comparing these two techniques, doctors hope to improve how they test for and monitor pancreatic conditions, ultimately leading to better care for patients.
Key takeaways
- Researchers are comparing two methods for collecting pancreatic fluid.
- The goal is to find which method better detects specific gene changes linked to IPMN.
- The study could help improve how pancreatic conditions are diagnosed.
- Only people 18 years or older with IPMN can take part.
- Participation involves two fluid collection procedures and possible follow-up after surgery.
Who may be eligible?
To join this study, you must be at least 18 years old. People of any gender can participate.
More specific details about your health condition and any treatments you might be having will be discussed with you by the study team. This helps ensure the study is right for you and safe.
The study is specifically looking for people with a condition called Intraductal Papillary Mucinous Neoplasia (IPMN) in their pancreas.
- Are you 18 years old or older?
- Have you been diagnosed with IPMN (Intraductal Papillary Mucinous Neoplasia) in your pancreas?
- Are you willing to undergo two different procedures to collect fluid samples?
- Are you able to participate in follow-up for up to 12 months, if required?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you will have two different procedures to collect fluid samples from your pancreas. These are the endoscopic aspiration of duodenopancreatic juice after secretin stimulation (ADPJ-secr) and endoscopic ultrasound-guided fine needle aspiration (EUS-FNA). Both are medical procedures that involve collecting fluid. The study will look at the samples collected from both procedures to see if they contain specific gene changes.
Some participants will also have surgery on their pancreas within 12 months of joining the study. This is part of their normal medical care, and the study will use information from these surgeries to learn more. The total time you'll be involved in the study can vary, especially if you have surgery, as follow-up information will be collected for up to 12 months.
Potential risks and benefits
Locations (1)
- —Spain
Common questions
What is IPMN?
IPMN stands for Intraductal Papillary Mucinous Neoplasia. It's a type of growth found in the ducts of the pancreas that can sometimes become cancerous over time.
What are GNAS and KRAS mutations?
These are specific changes in genes that can be found in IPMN and sometimes in pancreatic cancer. Finding them can give doctors more information about the growth.
What does a 'therapeutic confirmatory (Phase III)' study mean?
This refers to the stage of the study. A Phase III study often compares a new treatment or diagnostic method with standard ones, usually involving a larger number of people to confirm its benefits and safety.
Will I receive a new treatment in this study?
This study is focused on improving diagnostic methods, not on testing a new treatment. It's comparing ways to collect samples and analyse them.
What is an endoscope?
An endoscope is a long, thin, flexible tube with a light and camera on the end. It's used by doctors to look inside the body, usually through a natural opening, like the mouth.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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