Aspiration of Duodenopancreatic Juice After Secretin Stimulation vs Endoscopic Aspiration for Molecular Analysis of Intraductal Papillary Mucinous Intraductal Neoplasia.
NCT ID: NCT05914077
Last Updated: 2023-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
140 participants
INTERVENTIONAL
2023-09-13
2025-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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Duodenopancreatic aspiration after secretin stimulation + EUS-FNA
Duodenopancreatic aspiration after secretin stimulation will be performed followed by endoscopic ultrasound-guided fine needle aspiration (EUS-FNA)
Secretin
Secretin will be administered intravenous during 1 minute at a dose of 0,2 μg/Kg previous to the endoscopic procedure.
Endoscopic aspiration
Endoscopic aspiration of duodenopancreatic juice after secretin stimulation
Endoscopic ultrasound-guided fine needle aspiration
Endoscopic ultrasound-guided fine needle aspiration of intraductal papillary mucinous intraductal neoplasia (IPMN).
EUS-FNA + duodenopancreatic aspiration after secretin stimulation
Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) will be performed followed by duodenopancreatic aspiration after secretin stimulation
Secretin
Secretin will be administered intravenous during 1 minute at a dose of 0,2 μg/Kg previous to the endoscopic procedure.
Endoscopic aspiration
Endoscopic aspiration of duodenopancreatic juice after secretin stimulation
Endoscopic ultrasound-guided fine needle aspiration
Endoscopic ultrasound-guided fine needle aspiration of intraductal papillary mucinous intraductal neoplasia (IPMN).
Interventions
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Secretin
Secretin will be administered intravenous during 1 minute at a dose of 0,2 μg/Kg previous to the endoscopic procedure.
Endoscopic aspiration
Endoscopic aspiration of duodenopancreatic juice after secretin stimulation
Endoscopic ultrasound-guided fine needle aspiration
Endoscopic ultrasound-guided fine needle aspiration of intraductal papillary mucinous intraductal neoplasia (IPMN).
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
ALL
No
Sponsors
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Fundacion Clinic per a la Recerca Biomédica
OTHER
Responsible Party
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Locations
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Hospital Clínic de Barcelona
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Àngels Ginès, MD
Role: primary
Other Identifiers
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2022-002764-79
Identifier Type: -
Identifier Source: org_study_id
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