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Aspiration of duodenopancreatic juice after secretin stimulation (ADPJsecr-) vs endoscopic aspiration (EUS-FNA) for molecular analysis of intraductal papillary mucinous intraductal neoplasia (IPMN).
EU CTIS ID: 2024-519972-21-00
What this study is testing
To compare the detection rate of somatic mutations in GNAS and KRAS in liquid samples obtained by the techniques under study (ADPJ-secr and EUS-FNA) in patients with MPIN.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Be a man or woman over 18 years of age.
- 2. Willing to comply with the study procedures described in the protocol.
- 3. Willing and able to give written informed consent.
- 4. Meeting at least one of the following three criteria related to the diagnosis or prognosis of IPMN: 4.1. Diagnosis of IPMN based on evidence of the major criterion or the presence of at least 2 minor criteria. -Major criterion: Characteristic imaging on MRI and/or EUS (single or multiple cysts with clear ductal communication and/or focal or diffuse dilation ≥ 5 mm in diameter of the main pancreatic duct without apparent obstructive cause). -Minor criteria: a) Mucus-secreting cells and/or extracellular mucin in the cytological examination of intracystic fluid. b) Clearly mucoid or filamentous appearance of the intracystic fluid. c) CEA concentration in intracystic fluid >192 ng/mL or intracystic glucose < 50 mg/dL.
- 4.2. IPMN with cysts with a diameter ≥ 10 mm and/or focal or diffuse dilatation of the main pancreatic duct with a diameter ≥ 7 mm requiring EUS-FNA for diagnostic purposes or to assess risk or existence of malignancy following the main clinical practice guidelines.
- 4.3. IPMN with indication for surgical resection of the lesion.
You likely can't join if
- History of surgery that prevents endoscopic access to the ampulla of Vater in the case of AJPD-sec, or to the area of the stomach or intestine from which to perform FNA.
- Acute pancreatitis within the 30 days prior to inclusion.
- Pregnant women, women with the possibility of pregnancy during the month prior to inclusion, or women who are breastfeeding.
- Coagulopathy (PT < 25%, INR > 1.5, platelets < 50,000/mL) preventing FNA.
- Renal failure with GFR < 30 mL/min or patients on dialysis.
- Known hypersensitivity to any component of the ChiRhoStim® (human secretin) formulation.
See the full eligibility criteria
Who can join
- 1. Be a man or woman over 18 years of age.
- 2. Willing to comply with the study procedures described in the protocol.
- 3. Willing and able to give written informed consent.
- 4. Meeting at least one of the following three criteria related to the diagnosis or prognosis of IPMN: 4.1. Diagnosis of IPMN based on evidence of the major criterion or the presence of at least 2 minor criteria. -Major criterion: Characteristic imaging on MRI and/or EUS (single or multiple cysts with clear ductal communication and/or focal or diffuse dilation ≥ 5 mm in diameter of the main pancreatic duct without apparent obstructive cause). -Minor criteria: a) Mucus-secreting cells and/or extracellular mucin in the cytological examination of intracystic fluid. b) Clearly mucoid or filamentous appearance of the intracystic fluid. c) CEA concentration in intracystic fluid >192 ng/mL or intracystic glucose < 50 mg/dL.
- 4.2. IPMN with cysts with a diameter ≥ 10 mm and/or focal or diffuse dilatation of the main pancreatic duct with a diameter ≥ 7 mm requiring EUS-FNA for diagnostic purposes or to assess risk or existence of malignancy following the main clinical practice guidelines.
- 4.3. IPMN with indication for surgical resection of the lesion.
- 5. If the participant is a woman of childbearing potential, she must be willing to use highly effective contraceptive methods or practice sexual abstinence from the screening visit until one week after undergoing the procedure under study. Highly effective contraceptive methods include: combined (containing estrogen and progestogen) oral, intravaginal, or transdermal hormonal contraception associated with ovulation inhibition; progestogen-only oral, injectable, or implantable hormonal contraception associated with ovulation inhibition; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomized partner; and sexual abstinence.
- 6. If the participant is a woman of reproductive age, she must be willing to undergo a urine pregnancy test prior to inclusion in the study.
What rules you out
- History of surgery that prevents endoscopic access to the ampulla of Vater in the case of AJPD-sec, or to the area of the stomach or intestine from which to perform FNA.
- Acute pancreatitis within the 30 days prior to inclusion.
- Pregnant women, women with the possibility of pregnancy during the month prior to inclusion, or women who are breastfeeding.
- Coagulopathy (PT < 25%, INR > 1.5, platelets < 50,000/mL) preventing FNA.
- Renal failure with GFR < 30 mL/min or patients on dialysis.
- Known hypersensitivity to any component of the ChiRhoStim® (human secretin) formulation.
- Any clinically relevant medical condition that, in the opinion of the investigator, makes the patient unfit to participate in the study (underlying haematological disorders, autoimmune disease, immunodeficiency, gastrointestinal, psychiatric, renal, hepatic and cardiopulmonary disorders).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.