A physician or institution planning to perform secretin stimulation testing as an aid to the diagnosis of pancreatic disease should begin by assessing enough normal subjects (> 5) to develop proficiency in proper techniques and to generate normal response ranges for the commonly assessed parameters for pancreatic exocrine response to ChiRhoStim®.

In three crossover studies (CRC 98-1, CRC 98-2, and CRC 99-9) evaluating 21 different patients with a documented history of chronic pancreatitis, synthetic human secretin (sHS) was compared to synthetic porcine secretin (sPS) and biologically derived secretin (bPS). All of the patients treated with these drugs had peak bicarbonate concentrations of < 80 mEq/L.

Pancreatic secretory response to intravenous synthetic human secretin in 35 normal healthy subjects demonstrated a mean peak bicarbonate concentration of 100 mEq/L and a mean total volume over one hour of 260.7 mL. All 35 subjects had peak bicarbonate concentrations ≥ 80 mEq/L.

Stimulation of gastrin secretion to aid in the diagnosis of gastrinoma

ChiRhoStim® administered intravenously stimulates gastrin release in patients with gastrinoma (Zollinger-Ellison Syndrome), whereas no or only small changes in serum gastrin concentrations occur in normal subjects and in patients with duodenal ulcer disease. Deveney, et al. established the high sensitivity and specificity of the secretin stimulation test to aid in the diagnosis of gastrinoma and found using discriminant analysis that an increase from baseline of ≥ 110 pg/mL was the optimal point separating positive and negative tests.⁽⁸⁾ This gastrin response is the basis for the use of synthetic human secretin as a provocative test in the evaluation of patients in whom gastrinoma is a diagnostic consideration.

In a three way crossover study of 6 patients with tissue diagnosed gastrinoma, there was agreement among synthetic human secretin (ChiRhoStim®), synthetic porcine secretin and biologically derived porcine secretin regarding gastrin levels. Serum gastrin levels were reported to be > 110 pg/mL for all secretin products tested after stimulation with 0.4 mcg/kg secretin. Testing of ChiRhoStim® in 12 healthy volunteers demonstrated completely negative results for gastrinoma.

Facilitation of identification of the ampulla of Vater and the accessory papilla during endoscopic retrograde cholangiopancreatography (ERCP) to assist in cannulation of the pancreatic ducts

In a randomized, placebo controlled crossover study in 24 patients with pancreas divisum undergoing ERCP, synthetic human secretin administration at a dose of 0.2 mcg/kg resulted in 16 of 24 successful cannulations of the minor duct compared to 2 of 24 for placebo.

REFERENCES

5.    Jorpes, E. and Mutt V. On the biological assay of secretin. The reference standard. Acta Physiol Scand. 1966 Mar;66(3):316-25.

6.    Chey WY, Chang T-M, Secretin. In: Kasin AJ. Editor. Handbook of Biologically Active Peptides. Elsevier, Amsterdam. 2006;1115-1122.

7.    Whitcomb DC. Neurohormonal Control of the Exocrine Pancreas. In:Greeley JR G, editor. Endocrinology of the Gastrointestinal System. Totowa NJ:Humana Press. 1998;239-258.

8.    Deveney, C.W., et al. Use of Calcium and Secretin in the Diagnosis of Gastrinoma (Zollinger-Ellison Syndrome). Ann Intern Med. 1977 Dec;87(6):680-6.

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