NCT07285863

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
22mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Mar 2026Mar 2028

First Submitted

Initial submission to the registry

December 11, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 16, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

March 11, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

December 11, 2025

Last Update Submit

April 27, 2026

Conditions

Exocrine Pancreatic InsufficiencyChronic Pancreatitis

Keywords

pancreatic function testPancreatic fluid composition

Outcome Measures

Primary Outcomes (4)

  • Pancreatic Fluid Bicarbonate Composition

    A primary outcome will be the bicarbonate level (milliequivalent per liter) in the pancreatic fluid collected.

    5, 10, 15, and 20-minutes post-secretin administration

  • Pancreatic Fluid Sodium Composition

    A primary outcome will be the sodium level (milliequivalent per liter) in the pancreatic fluid collected.

    5, 10, 15, and 20-minutes post-secretin administration

  • Pancreatic Fluid Potassium Composition

    A primary outcome will be the potassium level (milliequivalent per liter) in the pancreatic fluid collected.

    5, 10, 15, and 20-minutes post-secretin administration

  • Pancreatic Fluid Chloride Composition

    A primary outcome will be the chloride level (milliequivalent per liter) in the pancreatic fluid collected.

    5, 10, 15, and 20-minutes post-secretin administration

Study Arms (1)

Healthy Participants

EXPERIMENTAL

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.

Drug: Secretin (human synthetic) - ChiRhoClin

Interventions

Secretin (human synthetic) - ChiRhoClinDRUG

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

Healthy Participants

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Exocrine Pancreatic InsufficiencyPancreatitis, Chronic

Interventions

Secretin

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesPancreatitisChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptide HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Samuel Han, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liz Lemke

CONTACT

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

Samuel Han, MD

CONTACT

han.samuel@mayo.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 11, 2025

First Posted

December 16, 2025

Study Start

March 11, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)