Aspiration of Duodenopancreatic Juice After Secretin Stimulation vs Endoscopic Aspiration for Mol… (NCT05914077) | Clinical Trial Compass
UnknownPhase 3
Aspiration of Duodenopancreatic Juice After Secretin Stimulation vs Endoscopic Aspiration for Molecular Analysis of Intraductal Papillary Mucinous Intraductal Neoplasia.
Spain140 participantsStarted 2023-09-13
Plain-language summary
Study to evaluate aspiration of duodenopancreatic juice after secretin stimulation (ADPJ-secr)versus endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for molecular analysis of intraductal papillary mucinous intraductal neoplasia.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Meet at least one of the following three criteria in relation to the diagnosis or prognosis of IPMN:
.1 Diagnosis of IMPN based on evidence of major criteria or existence of at least 2 minor criteria. Major criterion: Typical findings on MRI and/or EUS (single or multiple cysts with clear ductal communication and/or focal or diffuse dilatation # 5 mm in diameter of the main pancreatic duct without apparent obstructive cause). Minor criteria: a) Mucosecretory cells and/or extracellular mucin on cytological examination of intracystic fluid. b) Clear mucoid or filmy appearance of the intracystic fluid. c) Intracystic fluid CEA concentration \>192 ng/mL or intracystic glucose \< 50 mg/dL.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients with IPMN with GNAS and KRAS mutations in intracystic fluid obtained by EUS-FNA versus pancreatic juice obtained by ADPJ-secr after both techniques.
Timeframe: Through study completion, an average of 30 months
Trial details
NCT IDNCT05914077
SponsorFundacion Clinic per a la Recerca Biomédica
.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.
.3 IPMN with indication for surgical resection of the lesion.
. In case of a woman of childbearing age\*, willing to use highly effective contraception or practice sexual abstinence from the screening visit until one week after undergoing the procedure under study. Highly effective contraceptive methods will include: combined oral, intravaginal or transdermal hormonal contraceptives (containing oestrogens and progestogens) associated with ovulation inhibition; oral, injectable or implantable progestogen-only hormonal contraception associated with ovulation inhibition; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomised partner; and sexual abstinence. 6. If you are a woman of childbearing age, be willing to undergo a urine pregnancy test prior to inclusion in the study.
Exclusion criteria
. History of surgery that prevents endoscopic access to the major duodenal papilla in the case of ADPJ-secr, or to the area of the stomach or intestine from which to perform FNA.
. History of acute pancreatitis during the 30 days prior to inclusion.
. Pregnant women, women who may become pregnant during the month prior to inclusion or women who are breastfeeding.
. 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).