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

NCT01094535 | Withdrawn DMC

• 1 other identifier: AAAC0218
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage diameter change on S-MRCP of patients with pancreatic insufficiency

  12 months

• Pancreatic duct mean diameter of patients with high arginine-stimulated hormone levels

  12 months

Study Arms (1)

Secretin

EXPERIMENTAL

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

Drug: Synthetic Human Secretin

Interventions

Synthetic Human Secretin 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.

Also known as: RG1068

Secretin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Exocrine Pancreatic Insufficiency

Interventions

Secretin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Harold Frucht, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2010
• First Posted: March 29, 2010
• Study Start: September 1, 2007
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 6, 2015

Record last verified: 2015-04

Locations

US (1)