A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMayo Clinic
About this trial
The purpose of this study is to collect pancreas fluid from the duodenum using the endoscopic pancreas function collection method in healthy participants after pancreatic stimulation with human secretin.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Males or non-pregnant females
Age 18-80.
Participants must be in good health based on medical history (ASA Class 3 or below)
Participants must be willing and able to provide informed consent
Disqualifiers
History of any form of pancreatitis and/or other pancreatic diseases (e.g. pancreatic cysts, pancreatic masses).
History of inflammatory bowel disease
History of vagotomy.
History of surgically altered upper gastrointestinal anatomy (e.g. gastric bypass, Billroth I/II)
Trial design
Design model
Single group
Treatments tested in this trial
Secretin (human synthetic) - ChiRhoClin
DrugDuring endoscopic ultrasound (EUS), a dose of intravenous secretin (0.2 µg/kg) will be administered over the course of 1 minute to stimulate pancreatic ductal cells to secrete pancreas fluid. Duodenal fluid will be aspirated through the echoendoscope in 5 minute increments (5, 10, 15, and 20 minutes) after the secretin has been administered
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Healthy ParticipantsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pancreatic Fluid Bicarbonate Composition
A primary outcome will be the bicarbonate level (milliequivalent per liter) in the pancreatic fluid collected.
Time frame
5, 10, 15, and 20-minutes post-secretin administration2
Pancreatic Fluid Sodium Composition
A primary outcome will be the sodium level (milliequivalent per liter) in the pancreatic fluid collected.
Time frame
5, 10, 15, and 20-minutes post-secretin administration3
Pancreatic Fluid Potassium Composition
A primary outcome will be the potassium level (milliequivalent per liter) in the pancreatic fluid collected.
Time frame
5, 10, 15, and 20-minutes post-secretin administration4
Pancreatic Fluid Chloride Composition
A primary outcome will be the chloride level (milliequivalent per liter) in the pancreatic fluid collected.
Time frame
5, 10, 15, and 20-minutes post-secretin administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mayo Clinic
Lead sponsor
ChiRhoClin, Inc.
Collaborator
Source ClinicalTrials.gov