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 study about?

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.

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.

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.

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.

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.

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.

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 Study?

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.
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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Hospital Clinic De Barcelona	Barcelona	Spain
Ptek Twlac Hawhnaev Uasmcadcjqhx	Sabadell	Spain
Hpfhjlnl Df Lp Sdawh Cyqb I Sonh Pws	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	13.09.2023

Trial locations

Investigated drugs:

SECRETIN SYNTHETIC HUMAN

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.

Investigated diseases:

Intraductal papillary mucinous neoplasm

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.

Trial ID:

2024-519972-21-00

Protocol code:

RESCUE

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

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