Comparison of Secretin-enhanced Magnetic Resonance Cholangiopancreatography (S-MRCP) to Endoscopic Pancreatic Function Test (ePFT) in Diagnosing Pancreatic Exocrine Insufficiency

NCT01094600 | Withdrawn DMC

• 1 other identifier: AAAC7911
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of our study is to evaluate S-MRCP, in comparison to direct pancreatic function, to measure pancreatic exocrine function in patients who have symptoms suspicious for insufficiency. We hypothesize that S-MRCP imaging parameters will correlate well with the direct pancreatic exocrine functioning.

Conditions

Pancreatic Cancer

Keywords

Pancreatic cancer; Pancreatic resection; Synthetic human secretin; Secretin-enhanced MRCP; Endoscopic pancreatic function test; Pancreatic exocrine insufficiency

Outcome Measures

Primary Outcomes (1)

• Primary outcome: correlation between S-MRCP with ePFT

  The primary outcome that we will be measuring will be correlation between duodenal filling on S-MRCP (expressed as percent of duct volume change from baseline and maximal values following secretin administration) with maximal bicarbonate concentration from ePFT.

  30 days

Study Arms (1)

Secretin

EXPERIMENTAL

Single arm (open label).

Drug: Synthetic Human Secretin

Interventions

Synthetic Human Secretin DRUG

Twelve patients will undergo S-MRCP, at a dose of 0.2 ucg/kg per exam. 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
• Undergone surgical resection for adenocarcinoma no less than 3 months prior to enrollment
• Report significant abdominal pain/bloating or steatorrhea \>3x/week or demonstrate weight loss corresponding to \>10% of pre-surgery BMI.
• Scheduled for EGD/EUS to investigate the above clinical indicators.

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)
• Presence of pancreatic duct stent
• 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

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: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• 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: June 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 2, 2012

Record last verified: 2012-06