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

NCT ID: NCT07285863

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2028-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Exocrine Pancreatic Insufficiency Chronic Pancreatitis

Keywords

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pancreatic function test Pancreatic fluid composition

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Healthy Participants

Healthy participants without pancreatic disease who are undergoing an endoscopic ultrasound for a non-pancreatic indication. This arm will be stratified into 3 age groups: 18-35, 35-45, and 46+ years. 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.

Group Type EXPERIMENTAL

Secretin (human synthetic) - ChiRhoClin

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ChiRhoClin, Inc.

INDUSTRY

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Samuel Han

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samuel Han, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Central Contacts

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Liz Lemke

Role: CONTACT

Phone: 507-266-8760

Email: [email protected]

Samuel Han, MD

Role: CONTACT

Email: [email protected]

Related Links

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Other Identifiers

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25-011644

Identifier Type: -

Identifier Source: org_study_id