A Study of Synthetic Human Secretin (ChiRhoStim®) Administered Intravenously to Stimulate Exocrine Pancreas Fluid Secretion for Collection Via Endoscope and Laboratory Analysis of DNA Markers

Study Overview
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Brief Summary
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The following are the study hypothesis: Secretin administration compared to placebo will result in a statistically significantly greater percentage of collected fluid samples being predominantly of exocrine pancreas origin when samples are duodenal aspirates. Secretin administration compared to placebo will result in a statistically significantly greater percentage of collected fluid samples meeting the minimum specifications for use in the indicated laboratory test of DNA mutational analysis.

Official Title
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A Placebo Controlled, Double-Blind, Parallel, Multicenter Study of Synthetic Human Secretin (ChiRhoStim®) Administered Intravenously to Stimulate Exocrine Pancreas Fluid Secretion for Collection Via Endoscope and Laboratory Analysis of DNA Markers

Conditions
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Pancreatic Disease

Intervention / Treatment
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* Drug: ChiRhoStim
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented or suspected diagnosis of chronic pancreatitis or suspected diagnosis of pancreatic cancer. Undergoing Endoscopic Procedure. Age ≥ 18 years. Willing and able to sign informed consent, meeting IRB guidelines. Willing and able to meet all study requirements and obligations. Exclusion Criteria: Ongoing, active pancreatitis at the time of the procedure. Known adverse reaction to secretin. Recent (within one month) use of medication that can potentially cause pancreatitis, such as metronidazole, tetracycline, sulfonamides. Use of anticholinergic medication within 7 days of study. Pregnant women, nursing mothers, or women of childbearing potential not employing appropriate contraception. Acceptable methods of birth control are: intrauterine device, implantable progesterone device, progesterone intramuscular injection, oral contraceptive (started at least one month prior to Visit 1 and continuing for the duration of the trial), contraceptive patch, condoms with spermicide or abstinence. Any medical condition which in the judgment of the Principal Investigator makes participation of the patient in the study medically unwarranted. Known complete obstruction of the pancreatic duct. Patients who have received an investigational product/drug or device within 30 days prior to Visit 1.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ChiRhoStim<br>Human Secretin for Injection | Drug: ChiRhoStim<br>* Human Secretin for Injection<br>|
| Placebo Comparator: Placebo<br>Saline for Injection | Drug: Placebo<br>* Saline for Injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic Sample | Is Volume ≥ 3.5 mL Is HCO3 concentration ≥ 40 mEq/L Is DNA mutational analysis (K-ras-2 gene Fluorescence peak height ≥ 50 Relative Florescence Units panel assessable markers informative ≥ 8). (Note- The outcome value is boolean (yes or no) as an answer). | First 5 minutes after treatment administration | 
| Volume of Fluid ≥ 3.5mL (Boolean Expression Evaluated as Yes or no). | Volume of pancreatic fluid. The volume is the number of mL of pancreatic fluid. | First 5 minutes after treatment administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genetic End Marker