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Study Comparing Secretin Synthetic Human and Endoscopic Aspiration Techniques for Analyzing Pancreatic Cancer in Patients with Intraductal Papillary Mucinous Neoplasia

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying two conditions related to the pancreas: pancreatic cancer and intraductal papillary mucinous neoplasia (IPMN). The study will use a treatment called Chirhostim, which contains a substance known as secretin synthetic human. Secretin is a protein that helps stimulate the pancreas, and in this study, it will be used to help collect samples from the pancreas for analysis.

The purpose of the study is to compare two methods of collecting samples from the pancreas to detect specific genetic changes, known as mutations, in the genes GNAS and KRAS. These mutations can be important in understanding the nature of pancreatic conditions. The two methods being compared are called ADPJ-secr and EUS-FNA. ADPJ-secr involves collecting pancreatic juice after stimulating the pancreas with secretin, while EUS-FNA involves using a needle to collect samples directly from the pancreas with the help of an ultrasound.

Participants in the study will undergo both procedures to see which method is more effective at detecting these mutations. The study will also look at other factors, such as the concentration of DNA in the samples and the presence of other mutations like Tp53. The study aims to provide valuable information that could improve the diagnosis and treatment of pancreatic conditions. Participants will be monitored for any side effects from the procedures, and the study will continue until the end of 2026.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, willingness to comply with study procedures, and ability to provide informed consent.
For women of childbearing potential, a urine pregnancy test is required. Additionally, they must agree to use effective contraceptive methods or practice abstinence during the study period.
Step 2
Preparation for procedure
Participants are prepared for the procedure involving the collection of samples from the pancreas. This preparation includes understanding the procedure and any necessary pre-procedure instructions.
Step 3
Administration of medication
The medication Chirhostim, containing secretin synthetic human, is administered through an intravenous infusion. This medication is used to stimulate the pancreas for the collection of pancreatic juice.
Step 4
Sample collection
Two techniques are used to collect samples: ADPJ-secr (aspiration of duodenopancreatic juice after secretin stimulation) and EUS-FNA (endoscopic ultrasound-guided fine needle aspiration).
These samples are analyzed for the presence of specific mutations, such as GNAS and KRAS, which are important for understanding the condition.
Step 5
Post-procedure monitoring
Participants are monitored for any adverse effects following the procedures. This monitoring occurs at 24 hours and 7 days post-procedure to ensure safety and address any complications.
Step 6
Follow-up and analysis
The collected samples are analyzed for molecular characteristics. The results contribute to understanding the effectiveness of the techniques in detecting mutations.
Participants may undergo further follow-up if they are scheduled for pancreatic resection within 12 months, to compare findings with surgical outcomes.

Who can join the trial?

9 criteria

Be a man or woman over 18 years of age.
Willing to follow the study procedures as described in the study plan.
Willing and able to provide written consent after being informed about the study.
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Meet at least one of the following criteria related to the diagnosis or outlook of **IPMN** (a type of pancreatic condition):
- Diagnosis of **IPMN** based on specific imaging findings on **MRI** (Magnetic Resonance Imaging) or **EUS** (Endoscopic Ultrasound), such as single or multiple cysts with clear ductal communication or dilation of the main pancreatic duct.
- Presence of mucus-secreting cells or extracellular mucin in the fluid from the cyst, a mucoid or filamentous appearance of the fluid, or specific levels of **CEA** (Carcinoembryonic Antigen) or glucose in the fluid.
- **IPMN** with cysts that are 10 mm or larger, or dilation of the main pancreatic duct that is 7 mm or larger, requiring **EUS-FNA** (Endoscopic Ultrasound-Guided Fine Needle Aspiration) for diagnosis or to assess cancer risk.
- **IPMN** that requires surgical removal of the lesion.
- If the participant is a woman who can become pregnant, she must agree to use highly effective birth control methods or practice sexual abstinence from the start of the study until one week after the procedure. Effective birth control methods include hormonal contraception, intrauterine devices, or having a partner who has had a vasectomy.
- If the participant is a woman of reproductive age, she must agree to take a urine pregnancy test before joining the study.

Who cannot join the trial?

4 criteria

Patients who are not diagnosed with **pancreatic cancer** or **intraductal papillary mucinous neoplasia** cannot participate.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who do not belong to the specified clinical trial groups cannot participate. The specific group is not detailed here, but it is a requirement for eligibility.
Patients who are not able to provide consent or are considered part of a vulnerable population may not be eligible. A vulnerable population includes individuals who may have limited ability to make informed decisions.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Hospital Clinic De Barcelona
Barcelona, Spain
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Hospital De La Santa Creu I Sant Pau
Barcelona, Spain
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Parc Tauli Hospital Universitari
Sabadell, Spain

Trial locations

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Investigated drugs

Secretin
is a hormone used in this trial to stimulate the pancreas. It helps in the collection of pancreatic juice, which is then analyzed for specific genetic mutations. This process is part of the diagnostic procedure to understand certain pancreatic conditions better.
Endoscopic Ultrasound-Guided Fine Needle Aspiration (EUS-FNA)
is a technique used to collect tissue samples from the pancreas. In this trial, it is used to obtain samples for molecular analysis, helping to detect specific mutations that may be present in pancreatic lesions.

SECRETIN SYNTHETIC HUMAN

What is already known about the treatment

Secretin – Secretin is administered through an injection, typically given intravenously. It is currently used in medical practice and literature primarily for diagnostic purposes, particularly in pancreatic function tests. The main therapeutic indication for secretin is to stimulate the pancreas to release its digestive juices, which can help in diagnosing pancreatic disorders. At the molecular level, secretin works by binding to its receptor on pancreatic duct cells, leading to the secretion of bicarbonate-rich fluid. It is classified pharmacologically as a gastrointestinal agent.

Investigated diseases

Pancreatic Cancer
This is a disease where cells in the pancreas grow uncontrollably, forming a mass or tumor. It often begins in the ducts that carry digestive enzymes out of the pancreas. As it progresses, it can invade nearby tissues and spread to other parts of the body. Symptoms may not appear until the disease is advanced, making early detection challenging. It can cause abdominal pain, weight loss, and jaundice as it progresses. The disease can affect the body's ability to digest food and regulate blood sugar.
Intraductal Papillary Mucinous Neoplasia (IPMN)
This condition involves the growth of cystic tumors in the pancreatic ducts, which can produce thick fluid. These growths can be benign but have the potential to become cancerous over time. IPMN is characterized by the production of mucin, a thick, sticky substance, which can lead to ductal obstruction. As the condition progresses, it may cause symptoms like abdominal pain or pancreatitis. Monitoring is essential as some IPMNs can develop into invasive cancer. The condition is often discovered incidentally during imaging for other issues.