Pancreatic Disease
Conditions
Keywords
Genetic End Marker
Brief summary
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.
Interventions
DRUGChiRhoStim
Human Secretin for Injection
DRUGPlacebo
Saline for Injection
Sponsors
ChiRhoClin, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Documented or suspected diagnosis of chronic pancreatitis or suspected diagnosis of pancreatic cancer. 2. Undergoing Endoscopic Procedure. 3. Age ≥ 18 years. 4. Willing and able to sign informed consent, meeting IRB guidelines. 5. Willing and able to meet all study requirements and obligations.
Exclusion criteria
1. Ongoing, active pancreatitis at the time of the procedure. 2. Known adverse reaction to secretin. 3. Recent (within one month) use of medication that can potentially cause pancreatitis, such as metronidazole, tetracycline, sulfonamides. 4. Use of anticholinergic medication within 7 days of study. 5. 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. 6. Any medical condition which in the judgment of the Principal Investigator makes participation of the patient in the study medically unwarranted. 7. Known complete obstruction of the pancreatic duct. 8. Patients who have received an investigational product/drug or device within 30 days prior to Visit 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic Sample | First 5 minutes after treatment administration | 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). |
| Volume of Fluid ≥ 3.5mL (Boolean Expression Evaluated as Yes or no). | First 5 minutes after treatment administration | Volume of pancreatic fluid. The volume is the number of mL of pancreatic fluid. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ChiRhoStim Human Secretin for Injection 0.1 mL/kg IV | 26 |
| Placebo Saline for Injection 0.1 mL/kg IV | 29 |
| Total | 55 |
Baseline characteristics
| Characteristic | Placebo | ChiRhoStim | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 23 Participants | 50 Participants |
| Age Continuous | 47.2 years STANDARD_DEVIATION 12.3 | 49.6 years STANDARD_DEVIATION 15.5 | 48.3 years STANDARD_DEVIATION 13.7 |
| Region of Enrollment United States | 29 participants | 26 participants | 55 participants |
| Sex: Female, Male Female | 16 Participants | 18 Participants | 34 Participants |
| Sex: Female, Male Male | 13 Participants | 8 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 34 |
| serious Total, serious adverse events | 0 / 30 | 0 / 34 |
Outcome results
Primary
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).
Time frame: First 5 minutes after treatment administration
Primary
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.
Time frame: First 5 minutes after treatment administration
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ChiRhoStim | Volume of Fluid ≥ 3.5mL (Boolean Expression Evaluated as Yes or no). | Yes | 25 Participants |
| ChiRhoStim | Volume of Fluid ≥ 3.5mL (Boolean Expression Evaluated as Yes or no). | No | 1 Participants |
| Placebo | Volume of Fluid ≥ 3.5mL (Boolean Expression Evaluated as Yes or no). | Yes | 2 Participants |
| Placebo | Volume of Fluid ≥ 3.5mL (Boolean Expression Evaluated as Yes or no). | No | 27 Participants |