Last updated: September 15, 2023
Sponsor: Fundacion Clinic per a la Recerca Biomédica
Overall Status: Active - Recruiting
Phase
3
Condition
Digestive System Neoplasms
Treatment
Endoscopic ultrasound-guided fine needle aspiration
Secretin
Endoscopic aspiration
Clinical Study ID
NCT05914077
2022-002764-79
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 orprognosis of IPMN: 4.1 Diagnosis of IMPN based on evidence of major criteria or existence of at least 2minor criteria. Major criterion: Typical findings on MRI and/or EUS (single ormultiple cysts with clear ductal communication and/or focal or diffuse dilatation # 5mm in diameter of the main pancreatic duct without apparent obstructive cause). Minorcriteria: a) Mucosecretory cells and/or extracellular mucin on cytological examinationof 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 themain pancreatic duct with a diameter # 7 mm requiring EUS-FNA for diagnostic purposesor to assess risk or existence of malignancy following the main clinical practiceguidelines. 4.3 IPMN with indication for surgical resection of the lesion.
- In case of a woman of childbearing age*, willing to use highly effective contraceptionor practice sexual abstinence from the screening visit until one week after undergoingthe procedure under study. Highly effective contraceptive methods will include:combined oral, intravaginal or transdermal hormonal contraceptives (containingoestrogens and progestogens) associated with ovulation inhibition; oral, injectable orimplantable progestogen-only hormonal contraception associated with ovulationinhibition; intrauterine device; intrauterine hormone-releasing system; bilateraltubal occlusion; vasectomised partner; and sexual abstinence. 6. If you are a woman ofchildbearing age, be willing to undergo a urine pregnancy test prior to inclusion inthe study.
Exclusion
Exclusion Criteria:
- History of surgery that prevents endoscopic access to the major duodenal papilla inthe case of ADPJ-secr, or to the area of the stomach or intestine from which toperform 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 orwomen 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 haematologicaldisorders, autoimmune disease, immunodeficiency, gastrointestinal, psychiatric, renal,hepatic and cardiopulmonary disorders).
Study Design
Total Participants: 140
Treatment Group(s): 3
Primary Treatment: Endoscopic ultrasound-guided fine needle aspiration
Phase: 3
Study Start date:
September 13, 2023
Estimated Completion Date:
January 31, 2025
Connect with a study center
Hospital Clínic de Barcelona
Barcelona, 08036
SpainActive - Recruiting
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