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Recruitment Status : Withdrawn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
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Synthetic Human Secretin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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: 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.
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
|Principal Investigator:||Harold Frucht, MD||Columbia University|