Table of contents
- Trial overview
- Who is being studied
- What is being compared
- Study phase and size
- Main endpoint
- What this means for patients
Trial overview
This clinical trial is an interventional study, which means the researchers are testing a procedure and comparing it with another method.[1] The trial is listed as Authorised and is in Phase 3.[1]
The study uses SECRETIN SYNTHETIC HUMAN as part of a secretin-stimulation procedure called Chirhostim in the trial record.[1] The trial title says it is looking at aspiration of duodenopancreatic juice after secretin stimulation versus endoscopic aspiration for molecular analysis of intraductal papillary mucinous intraductal neoplasia, also called IPMN.[1]
Who is being studied
The conditions listed in the trial are pancreatic cancer and intraductal papillary mucinous intraductal neoplasia (IPMN).[1] IPMN is a pancreatic growth that can make mucus and may need closer testing to understand it better.
The source data do not give the full participation rules, but they show that the study is focused on patients with these pancreatic conditions.[1]
What is being compared
The study compares two ways of getting liquid samples for testing: ADPJsecr, which means aspiration of duodenopancreatic juice after secretin stimulation, and EUS-FNA, which means endoscopic ultrasound-guided fine needle aspiration.[1]
In simple terms, one method collects pancreatic juice after secretin stimulation, and the other method collects fluid with a needle guided by endoscopic ultrasound.[1] The goal is to see which method better detects gene changes in the sample.[1]
Study phase and size
The trial is in Phase 3, which usually means a later study stage with more participants than early testing phases.[1] The planned enrollment is 140 people.[1]
Because it is a larger study, the researchers are likely trying to confirm how well the sampling method works in the target patient group.[1]
Main endpoint
The main outcome is the proportion of patients with GNAS and KRAS mutations found in the samples from each technique.[1] A proportion means the number of patients with a result divided by the total number of patients tested.
These mutations are being checked in intracystic fluid from EUS-FNA and in pancreatic juice from ADPJsecr after both techniques are used.[1] The brief summary says the study aims to compare the detection rate of somatic mutations in GNAS and KRAS in liquid samples obtained by the two methods.[1]
What this means for patients
For patients, this trial is about finding the best way to collect fluid for molecular testing in pancreatic disease.[1] Molecular testing looks for gene changes that may help doctors understand the lesion or tumor better.
The study does not focus on symptom relief or drug treatment results in the source data.[1] Instead, it focuses on whether one sample-collection method finds important mutations more often than the other.[1]
