A Study of Synthetic Human Secretin (ChiRhoStim®) Administered Intravenously to Stimulate Exocrin… (NCT01087801) | Clinical Trial Compass
CompletedPhase 3
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
United States64 participantsStarted 2007-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
âś“. Documented or suspected diagnosis of chronic pancreatitis or suspected diagnosis of pancreatic cancer.
âś“. Undergoing Endoscopic Procedure.
✓. Age ≥ 18 years.
âś“. Willing and able to sign informed consent, meeting IRB guidelines.
âś“. Willing and able to meet all study requirements and obligations.
Exclusion criteria
âś•. Ongoing, active pancreatitis at the time of the procedure.
âś•. Known adverse reaction to secretin.
âś•. Recent (within one month) use of medication that can potentially cause pancreatitis, such as metronidazole, tetracycline, sulfonamides.
âś•. Use of anticholinergic medication within 7 days of study.
âś•. 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.
What they're measuring
1
Endoscopic Sample
Timeframe: First 5 minutes after treatment administration
2
Volume of Fluid ≥ 3.5mL (Boolean Expression Evaluated as Yes or no).
Timeframe: First 5 minutes after treatment administration