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Trial Title:
Aspiration of Duodenopancreatic Juice After Secretin Stimulation vs Endoscopic Aspiration for Molecular Analysis of Intraductal Papillary Mucinous Intraductal Neoplasia.
NCT ID:
NCT05914077
Condition:
Intraductal Papillary Mucinous Neoplasm of Pancreas
Conditions: Official terms:
Neoplasms, Cystic, Mucinous, and Serous
Pancreatic Neoplasms
Secretin
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Secretin
Description:
Secretin will be administered intravenous during 1 minute at a dose of 0,2 μg/Kg previous
to the endoscopic procedure.
Arm group label:
Duodenopancreatic aspiration after secretin stimulation + EUS-FNA
Arm group label:
EUS-FNA + duodenopancreatic aspiration after secretin stimulation
Intervention type:
Procedure
Intervention name:
Endoscopic aspiration
Description:
Endoscopic aspiration of duodenopancreatic juice after secretin stimulation
Arm group label:
Duodenopancreatic aspiration after secretin stimulation + EUS-FNA
Arm group label:
EUS-FNA + duodenopancreatic aspiration after secretin stimulation
Intervention type:
Procedure
Intervention name:
Endoscopic ultrasound-guided fine needle aspiration
Description:
Endoscopic ultrasound-guided fine needle aspiration of intraductal papillary mucinous
intraductal neoplasia (IPMN).
Arm group label:
Duodenopancreatic aspiration after secretin stimulation + EUS-FNA
Arm group label:
EUS-FNA + duodenopancreatic aspiration after secretin stimulation
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
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. Meet at least one of the following three criteria in relation to the diagnosis or
prognosis of IPMN:
4.1 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.
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. 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:
1. 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.
2. History of acute pancreatitis during the 30 days prior to inclusion.
3. Pregnant women, women who may become pregnant during the month prior to inclusion or
women who are breastfeeding.
4. Coagulopathy (PT < 25%, INR > 1.5, platelets < 50,000/mL) preventing FNA.
5. Renal failure with GFR < 30 mL/min or patients on dialysis.
6. Known hypersensitivity to any component of the ChiRhoStim® (human secretin)
formulation.
7. 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Clínic de Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Àngels Ginès, MD
Investigator:
Last name:
Àngels Ginès, MD
Email:
Principal Investigator
Start date:
September 13, 2023
Completion date:
January 2025
Lead sponsor:
Agency:
Fundacion Clinic per a la Recerca Biomédica
Agency class:
Other
Source:
Fundacion Clinic per a la Recerca Biomédica
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05914077
