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

NCT ID: NCT01094535

Last Updated: 2015-04-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2012-09-30

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).

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Secretin

One-arm (open label): Synthetic Human Secretin. Patients will undergo four Secretin-enhanced magnetic resonance cholangiopancreatography (S-MRCP) evaluations.

Group Type: EXPERIMENTAL

Synthetic Human Secretin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

RG1068

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harold Frucht, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAC0218

Identifier Type: -

Identifier Source: org_study_id