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Secretin-enhanced Magnetic Resonance Cholangiopancreatography (S-MRCP) and Pancreatic Function Following Surgery

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ClinicalTrials.gov Identifier: NCT01094535
Recruitment Status : Withdrawn (Poor enrollment)
First Posted : March 29, 2010
Last Update Posted : April 6, 2015
Sponsor:
Information provided by (Responsible Party):
Columbia University

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Synthetic Human Secretin Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: MRCP With Secretin Stimulation for the Evaluation of Pancreatic Endocrine and Exocrine Function Following Surgical Resection for Pancreatic Adenocarcinoma
Study Start Date : September 2007
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Secretin
One-arm (open label): Synthetic Human Secretin. Patients will undergo four Secretin-enhanced magnetic resonance cholangiopancreatography (S-MRCP) evaluations.
Drug: Synthetic Human Secretin
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. Twelve patients will each undergo four Secretin-enhanced magnetic resonance cholangiopancreatography (S-MRCP) evaluations, at a dose of 0.2 ucg/kg per exam, each S-MRCP will require 16-32 ucg of secretin (12 vials). Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg.
Other Name: RG1068




Primary Outcome Measures :
  1. Percent of duct volume change of patients with bicarbonate concentration of duodenal fluid aspirate or acid steatocrit [ Time Frame: 12 months ]
    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).


Secondary Outcome Measures :
  1. Percentage diameter change on S-MRCP of patients with pancreatic insufficiency [ Time Frame: 12 months ]
    In those patients who are undergoing endocrine pancreatic testing, our secondary aim is to investigate the relationship between other radiological parameters, including percentage diameter change on S-MRCP, with other clinical markers of pancreatic insufficiency, including fecal elastase-1 and vitamin levels, patients' grading of abdominal symptoms, quality-of-life questionnaire scores, and body mass index (BMI).

  2. Pancreatic duct mean diameter of patients with high arginine-stimulated hormone levels [ Time Frame: 12 months ]
    Another secondary aim will be to evaluate MRI imaging parameters (primarily maximal gadolinium signal enhancement, but also non-enhancement measures such as total volume and mean T1 signal) with arginine-stimulated hormone levels (primarily arginine-stimulated insulin levels, but we will also be examining glucagon, amylin, somatostatin and Cpeptide levels).



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094535


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Harold Frucht, MD Columbia University

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Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT01094535     History of Changes
Other Study ID Numbers: AAAC0218
First Posted: March 29, 2010    Key Record Dates
Last Update Posted: April 6, 2015
Last Verified: April 2015

Keywords provided by Columbia University:
Pancreatic adenocarcinoma
Synthetic human secretin
Secretin-enhanced MRCP
Pancreatic insufficiency
Endoscopic Pancreatic Function Test (ePFT)
Endocrine pancreatic function test
Exocrine pancreatic function test

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Secretin
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs