Aspiration of Duodenopancreatic Juice After Secretin Stimulation vs Endoscopic Aspiration for Molecular Analysis of Intraductal Papillary Mucinous Intraductal Neoplasia.
RESCUE
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2023
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2023
CompletedFirst Posted
Study publicly available on registry
June 22, 2023
CompletedStudy Start
First participant enrolled
September 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedSeptember 18, 2023
September 1, 2023
1.3 years
May 4, 2023
September 15, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
In intracystic fluid obtained by EUS-FNA versus pancreatic juice obtained by ADPJ-secr after both techniques.
Through study completion, an average of 30 months
Secondary Outcomes (46)
Proportion of patients with IPMN with Tp53 mutations.
Through study completion, an average of 30 months
DNA concentration expressed in ng/µl
Through study completion, an average of 30 months
Proportion of suitable samples obtained by the two techniques under study (ADPJ-secr and EUS-FNA) for molecular analysis.
Through study completion, an average of 30 months
Proportion of patients undergoing pancreatic resection with a pathological diagnosis of IPMN who have mutations in GNAS and/or KRAS
Through study completion, an average of 30 months
Proportion of patients undergoing pancreatic resection without a pathological diagnosis of IPMN who do not have GNAS and/or KRAS mutations
Through study completion, an average of 30 months
- +41 more secondary outcomes
Study Arms (2)
Duodenopancreatic aspiration after secretin stimulation + EUS-FNA
EXPERIMENTALDuodenopancreatic aspiration after secretin stimulation will be performed followed by endoscopic ultrasound-guided fine needle aspiration (EUS-FNA)
EUS-FNA + duodenopancreatic aspiration after secretin stimulation
EXPERIMENTALEndoscopic ultrasound-guided fine needle aspiration (EUS-FNA) will be performed followed by duodenopancreatic aspiration after secretin stimulation
Interventions
Secretin will be administered intravenous during 1 minute at a dose of 0,2 μg/Kg previous to the endoscopic procedure.
Endoscopic aspiration of duodenopancreatic juice after secretin stimulation
Endoscopic ultrasound-guided fine needle aspiration of intraductal papillary mucinous intraductal neoplasia (IPMN).
Eligibility Criteria
You may qualify if:
- 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 or prognosis of IPMN:
- 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.
- 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.
- IPMN with indication for surgical resection of the lesion.
You may not qualify if:
- 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.
- 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 haematological disorders, autoimmune disease, immunodeficiency, gastrointestinal, psychiatric, renal, hepatic and cardiopulmonary disorders).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2023
First Posted
June 22, 2023
Study Start
September 13, 2023
Primary Completion
January 1, 2025
Study Completion
January 1, 2025
Last Updated
September 18, 2023
Record last verified: 2023-09