Aspiration of Duodenopancreatic Juice After Secretin Stimulation vs Endoscopic Aspiration for Molecular Analysis of Intraductal Papillary Mucinous Intraductal Neoplasia. (RESCUE)

Fundacion Clinic per a la Recerca Biomédica

Status and phase: Enrolling; Phase 3

Conditions: Intraductal Papillary Mucinous Neoplasm of Pancreas

Treatments: Procedure: Endoscopic aspiration; Drug: Secretin; Procedure: Endoscopic ultrasound-guided fine needle aspiration

Study type: Interventional

Funder types: Other

Identifiers

NCT05914077

2022-002764-79

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Duodenopancreatic aspiration after secretin stimulation + EUS-FNA

Experimental group

Description:

Duodenopancreatic aspiration after secretin stimulation will be performed followed by endoscopic ultrasound-guided fine needle aspiration (EUS-FNA)

Treatment:

Drug: Secretin

Procedure: Endoscopic aspiration

Procedure: Endoscopic ultrasound-guided fine needle aspiration

EUS-FNA + duodenopancreatic aspiration after secretin stimulation

Experimental group

Description:

Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) will be performed followed by duodenopancreatic aspiration after secretin stimulation

Treatment:

Drug: Secretin

Procedure: Endoscopic aspiration

Procedure: Endoscopic ultrasound-guided fine needle aspiration