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

Study Overview

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

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.

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).

Pancreatic Cancer

DRUG: Synthetic Human Secretin

AAAC0218

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-03-25	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-04-03
First Submitted that Met QC Criteria 2010-03-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-04-06
First Posted (ESTIMATED) 2010-03-29	Results First Posted N/A	Last Verified 2015-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Screening

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/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 resona

Participant Group/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 resona

Primary Outcome Measures	Measure Description	Time Frame
Percent of duct volume change of patients with bicarbonate concentration of duodenal fluid aspirate or acid steatocrit	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

Secondary Outcome Measures	Measure Description	Time Frame
Percentage diameter change on S-MRCP of patients with pancreatic insufficiency	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).	12 months
Pancreatic duct mean diameter of patients with high arginine-stimulated hormone levels	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).	12 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Harold Frucht, MD, Columbia University

Publications

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General Publications

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Clinical Trial Record