Aspiration of duodenopancreatic juice after secretin stimulation (ADPJsecr-) vs endoscopic aspiration (EUS-FNA) for molecular analysis of intraductal papillary mucinous intraductal neoplasia (IPMN).
Key facts
- Where
- Barcelona és Sabadell, SpanyolországSee the 3 sites
- Phase
- 3. fázis
Where in Spanyolország
- Hospital Clinic de BarcelonaBarcelona, SpanyolországToborzás még nem indult
- Hospital de la Santa Creu i Sant PauBarcelona, SpanyolországToborzás még nem indult
- Parc Tauli Hospital UniversitariSabadell, SpanyolországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Trial code
- EU 2024-519972-21-00
- Record updated
- 2025. január 14.
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: Be a man or woman over 18 years of age; Willing to comply with the study procedures described in the protocol; Willing and able to give written informed consent; 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; 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; 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.
Exclusion: 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; 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; 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); Coagulopathy (PT < 25%, INR > 1.5, platelets < 50,000/mL) preventing FNA; Renal failure with GFR < 30 mL/min or patients on dialysis.