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

Purpose

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.

Conditions

  • Exocrine Pancreatic Insufficiency
  • Chronic Pancreatitis

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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)

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Healthy Participants 		Healthy participants without pancreatic disease who are undergoing an endoscopic ultrasound for a non-pancreatic indication. Participants will be given a standard dose of intravenous human secretin (0.2 mcg/kg) during the endoscopic ultrasound. During this time, pancreatic fluid will be collected at 5 minutes, 10 minutes, 15 minutes, and 20 minutes after secretin administration.
  • 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

Recruiting Locations

Mayo Clinic in Rochester
Rochester, Minnesota 55905
Contact:
Liz Lemke
507-266-3317

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Liz Lemke
507-266-3317
Lemke.Elizabeth@mayo.edu