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

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ClinicalTrials.gov Identifier: NCT01094600
Recruitment Status : Withdrawn
First Posted : March 29, 2010
Last Update Posted : July 2, 2012
Sponsor:
Information provided by (Responsible Party):
Columbia University

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.

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, pancreatic resection is still associated with significant postoperative malnutrition, maldigestion, and glucose intolerance, mostly as a result of pancreatic insufficiency. Quantifying individual 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 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 evaluate for pancreatic exocrine insufficiency. This will be a prospective study of twelve patients who have undergone pancreatic resection and who have symptoms of abdominal pain, steatorrhea or weight loss. We will be comparing quantitative parameters of S-MRCP (maximal change in pancreatic duct diameter and volume before and after secretin administration) with endoscopic pancreatic function testing (maximal bicarbonate concentration in duodenal aspirate after secretin administration).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Secretin Enhanced MRCP to Endoscopic Pancreatic Function Testing in Diagnosing Exocrine Insufficiency in Patients Who Have Undergone Pancreas Cancer Resection
Study Start Date : June 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

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Arm Intervention/treatment
Experimental: Secretin
Single arm (open label).
Drug: Synthetic Human Secretin
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.
Other Name: RG1068




Primary Outcome Measures :
  1. Primary outcome: correlation between S-MRCP with ePFT [ Time Frame: 30 days ]
    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.



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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
  • 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.

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)
  • 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

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): NCT01094600


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: NCT01094600     History of Changes
Other Study ID Numbers: AAAC7911
First Posted: March 29, 2010    Key Record Dates
Last Update Posted: July 2, 2012
Last Verified: June 2012

Keywords provided by Columbia University:
Pancreatic cancer
Pancreatic resection
Synthetic human secretin
Secretin-enhanced MRCP
Endoscopic pancreatic function test
Pancreatic exocrine insufficiency

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Exocrine Pancreatic Insufficiency
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