MRCP With Secretin Stimulation for the Evaluation of Pancreatic Endocrine and Exocrine Function Following Surgical Resection for Pancreatic Adenocarcinoma
Surgical resection offers the only hope of cure for pancreatic adenocarcinoma. While
perioperative mortality rates have declined in recent years, pancreatectomy is still
associated with significant postoperative malnutrition, maldigestion, and glucose
intolerance, mostly as a result of pancreatic insufficiency. Quantifying residual pancreatic
function remains a challenge, but is essential in improving the survival and quality of life
of pancreatic cancer patients. Secretin-enhanced magnetic resonance cholangiopancreatography
(S-MRCP)has recently emerged as a widely-accepted noninvasive technique to assess
morphological changes in the pancreatic ducts, as well as functional secretory capacity of
the gland. The aim of our study is to evaluate S-MRCP as a means to assess pancreatic
reserve in patients who will undergoing surgical resection for pancreatic carcinoma. As an
adjunct to S-MRCP, we will also evaluate the concomitant use of dynamic MRI with contrast
enhancement. This will be a prospective study of twelve patients who will undergo S-MRCP/MRI
within 30 days of surgery and then at 3, 6, and 12 months post-operatively. Quantitative
analysis of S-MRCP will include pancreatic duct diameter and volume before and after
secretin administration. MRI will be analyzed for mean T1 signal intensity, total
parenchymal volume, and gadolinium enhancement. These radiological parameters will be
compared to clinical parameters of exocrine function(subjective reporting of steatorrhea and
abdominal pain as well as levels of fecal elastase1 and fat soluble vitamins in stool
samples) as well as endocrine function (fasting blood glucose, hemoglobin A1c, amylin,
glucagon, and somatostatin levels, as well as arginine-stimulated levels of islet cell
hormones).
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
S-MRCP and ePFT concordance
Our primary aim is to compare S-MRCP with either Endoscopic Pancreatic Function Test (ePFT) (in those patients who undergo esophagogastroduodenoscopy [EGD] or endoscopic ultrasound [EUS]) or acid steatocrit. The primary outcome will be the correlation between duodenal filling on SMRCP(expressed as percent of duct volume change from baseline and maximal values following secretin administration) with either 1) maximal bicarbonate concentration of duodenal fluid aspirate or 2) acid steatocrit (a measure of steatorrhea, expressed as volumetric percentage).
12 months
No
Harold Frucht, MD
Principal Investigator
Columbia University
United States: Food and Drug Administration
AAAC0218
NCT01094535
January 2012
April 2012
Name | Location |
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Columbia University Medical Center | New York, New York 10032 |