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MRCP With Secretin Stimulation for the Evaluation of Pancreatic Endocrine and Exocrine Function Following Surgical Resection for Pancreatic Adenocarcinoma

18 Years
75 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

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

Inclusion Criteria:

- 18 years of age and older.

- Tissue-confirmed diagnosis of pancreatic adenocarcinoma.

- Scheduled for surgical resection of the adenocarcinoma (Whipple or distal

- Able to give informed consent

Exclusion Criteria:

- History of any radiation therapy to the abdomen prior to surgery.

- Any contraindication to MRI, including but not limited to implanted metal devices
(e.g. pacemaker, berry aneurysm clips, neural stimulator, cochlear implants, or metal
in the eye).

- Treatment with an investigational drug within 1 month prior to the day of the study
drug administration.

- Current enrollment in any other interventional study.

- Creatinine greater than 2.0.

- Significant liver disease, liver masses, or evidence of portal hypertension.

- Pregnancy.

- History of sensitivity to secretin.

- Unwilling or unable to sign informed consent.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

S-MRCP and ePFT concordance

Outcome Description:

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).

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Harold Frucht, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University


United States: Food and Drug Administration

Study ID:




Start Date:

January 2012

Completion Date:

April 2012

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic adenocarcinoma
  • Synthetic human secretin
  • Secretin-enhanced MRCP
  • Pancreatic insufficiency
  • Endoscopic Pancreatic Function Test (ePFT)
  • Endocrine pancreatic function test
  • Exocrine pancreatic function test
  • Adenocarcinoma
  • Pancreatic Neoplasms



Columbia University Medical Center New York, New York  10032