Clinical trial NCT01094535: Secretin-enhanced Magnetic Resonance Cholangiopancreatography (S-MRCP) and Pancreatic Function Following Surgery
Official title: MRCP With Secretin Stimulation for the Evaluation of Pancreatic Endocrine and Exocrine Function Following Surgical Resection for Pancreatic Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pancreatic Cancer
Keywords: Pancreatic adenocarcinoma
Synthetic human secretin
Secretin-enhanced MRCP
Pancreatic insufficiency
Endoscopic Pancreatic Function Test (ePFT)
Endocrine pancreatic function test
Exocrine pancreatic function test
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2010-03-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The aim of this study will be to determine whether secretin-enhanced MRCP (S-MRCP) as well as traditional magnetic resonance imaging (MRI) of the pancreas will allow the investigators to quantify the pancreas' ability to secrete hormones as well as digestive enzymes, both before and after surgery. The investigators hypothesize that S-MRCP will provide a novel non-invasive measure of pancreatic function.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older.
* Tissue-confirmed diagnosis of pancreatic adenocarcinoma.
* Scheduled for surgical resection of the adenocarcinoma (Whipple or distal pancreatectomy).
* 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.

Primary outcomes:
measure: Percent of duct volume change of patients with bicarbonate concentration of duodenal fluid aspirate or acid steatocrit
timeFrame: 12 months
Secondary outcomes:
measure: Percentage diameter change on S-MRCP of patients with pancreatic insufficiency
timeFrame: 12 months
measure: Pancreatic duct mean diameter of patients with high arginine-stimulated hormone levels
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Harold Frucht, MD
role: PRINCIPAL_INVESTIGATOR
References: