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Recruiting NCT07285863

A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects

Phase IV Interventional Exocrine Pancreatic Insufficiency Chronic Pancreatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Secretin (human synthetic) - ChiRhoClin.
Who it may be relevant to
Registry conditions: Exocrine Pancreatic Insufficiency, Chronic Pancreatitis. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-Label Study On The Effects Of Human Secretin For Injection (CHIROSTIM) On Pancreatic Fluid Composition In Normal Human Volunteer Participants

Overview

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.

Interventions

  • Drug Secretin (human synthetic) - ChiRhoClin
    During 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

Primary outcome measures

  • Pancreatic Fluid Bicarbonate Composition [Time frame: 5, 10, 15, and 20-minutes post-secretin administration]
  • Pancreatic Fluid Sodium Composition [Time frame: 5, 10, 15, and 20-minutes post-secretin administration]
  • Pancreatic Fluid Potassium Composition [Time frame: 5, 10, 15, and 20-minutes post-secretin administration]
  • Pancreatic Fluid Chloride Composition [Time frame: 5, 10, 15, and 20-minutes post-secretin administration]

Eligibility criteria

Inclusion criteria

  • 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
  • Receiving an endoscopic ultrasound for a non-pancreatic indication

Exclusion criteria

  • 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)
  • History of liver disease
  • Pregnant women or nursing mothers
  • Regular use of anticholinergics
  • > 2 drinks of alcohol daily
  • Smokers (cigarette)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT07285863 · 25-011644

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗