Clinical trial NCT05914077: Aspiration of Duodenopancreatic Juice After Secretin Stimulation vs Endoscopic Aspiration for Molecular Analysis of Intraductal Papillary Mucinous Intraductal Neoplasia.
Official title: Aspiration of Duodenopancreatic Juice After Secretin Stimulation (ADPJ-secr-) vs Endoscopic Aspiration (EUS-FNA) for Molecular Analysis of Intraductal Papillary Mucinous Intraductal Neoplasia (IPMN).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Intraductal Papillary Mucinous Neoplasm of Pancreas
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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.


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).

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Proportion of patients with IPMN with Tp53 mutations.
timeFrame: Through study completion, an average of 30 months
measure: DNA concentration expressed in ng/µl
timeFrame: Through study completion, an average of 30 months
measure: Proportion of suitable samples obtained by the two techniques under study (ADPJ-secr and EUS-FNA) for molecular analysis.
timeFrame: Through study completion, an average of 30 months
measure: Proportion of patients undergoing pancreatic resection with a pathological diagnosis of IPMN who have mutations in GNAS and/or KRAS
timeFrame: Through study completion, an average of 30 months
measure: Proportion of patients undergoing pancreatic resection without a pathological diagnosis of IPMN who do not have GNAS and/or KRAS mutations
timeFrame: Through study completion, an average of 30 months
measure: Proportion of patients undergoing pancreatic resection with Tp53 mutations
timeFrame: Through study completion, an average of 30 months
measure: Proportion of patients undergoing pancreatic resection without Tp53 mutations.
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (diameter of the largest cystic lesion) obtained by EUS.
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (maximum diameter of the main pancreatic duct) obtained by EUS.
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (type of main pancreatic duct dilatation) obtained by EUS.
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (location of the lesion) obtained by EUS.
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (presence > 1 cystic lesion) obtained by EUS.
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (mural nodules) obtained by EUS.
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (signs of chronic pancreatitis) obtained by EUS.
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (intraductal calcifications) obtained by EUS.
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (pancreatic atrophy) obtained by EUS.
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to age
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to sex
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to smoking
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to chronic alcohol consumption
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to hypertension
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to type 2 diabetes mellitus
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to heart failure
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to chronic liver disease.
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to chronic kidney disease.
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to neoplasms.
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to history of acute pancreatitis
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to previous diagnosis of chronic pancreatitis
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to family history (1st degree) of pancreatic cancer
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to time since diagnosis of IPMN
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to morphological type of IPMN
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of amylase
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of lipase
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of creatinine
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of total bilirrubin
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of AST
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of ALT (U/L)
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of GGT (U/L)
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of alkaline phosphatase (U/L)
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of hemoglobin (g/L)
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of platelets (U/L)
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of CA 19.9 (u/L)
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of CEA (U/l)
timeFrame: Through study completion, an average of 30 months
measure: To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of glycated hemoglobin.(%).
timeFrame: Through study completion, an average of 30 months
measure: To assess whether mutational status predicts the occurrence of adverse effects associated with the techniques under study at 24 hours and 7 days following the performance of the techniques under study.
timeFrame: Through study completion, an average of 30 months
measure: Proportion of patients with Serious Adverse Events
timeFrame: At 24 hours and 7 days after the techniques under study.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
References: