title: Administration of secretin (RG1068) increases the sensitivity of detection of duct abnormalities by magnetic resonance cholangiopancreatography in patients with pancreatitis.
abstract: OBJECTIVE
  Administration of secretin improves noninvasive imaging of the pancreatic duct with magnetic resonance cholangiopancreatography (MRCP). We performed a large prospective study to investigate whether synthetic human secretin (RG1068)-stimulated MRCP detects pancreatic duct abnormalities with higher levels of sensitivity than MRCP.
  
  
  METHODS
  We performed a phase 3, multicenter, baseline-controlled study of patients with acute or acute recurrent pancreatitis who were scheduled to undergo endoscopic retrograde cholangiopancreatography (ERCP) between March 26, 2008, and October 28, 2009. Patients underwent a baseline MRCP that was immediately followed by administration of RG1068 and repeat MRCP and then underwent ERCP within 30 days; they were followed up for 30 days. MRCP and ERCP images were read centrally by 3 radiologists and 2 endoscopists, respectively, who were all independent and blinded; pancreatic duct abnormalities were evaluated. The accuracy of MRCP was evaluated using ERCP as the standard.
  
  
  RESULTS
  In total, 258 patients were enrolled in the study; 251 MRCP image sets were assessed, and 236 patients had evaluable ERCPs. Pancreatic duct abnormalities were observed in 60.2% of ERCP images. All radiologists identified duct abnormalities in RG1068-ciné MRCP image sets with significantly higher levels of sensitivity (P < .0001) than in images from MRCP, with minimal loss of specificity. Adverse events were reported in 38.0% of patients after MRCP and 68.1% after ERCP. Of the 55 patients who experienced a serious adverse event, 3 (1.2%) and 52 (20.5%) of the events were reported to be temporally associated with MRCP and ERCP, respectively. The adverse events most frequently considered related to RG1068 were nausea, abdominal pain, and flushing; most were mild.
  
  
  CONCLUSIONS
  Compared with images from MRCP, those from RG1068-stimulated MRCP are improved in many aspects and could aid in diagnosis and clinical decision making for patients with acute, acute recurrent, or chronic pancreatitis. RG1068-enhanced MRCP might also better identify patients in need of therapeutic ERCP (ClinicalTrials.gov, Number: NCT00660335).
authors.affiliation: Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana. Electronic address: ssherman@iupui.edu.
authors.forename: Stuart
authors.initials: S
authors.lastname: Sherman
authors.affiliation: Department of Medicine, University of Minnesota, Minneapolis, Minnesota.
authors.forename: Martin L
authors.initials: ML
authors.lastname: Freeman
authors.affiliation: Department of Medicine, Methodist Medical Center, Dallas, Texas.
authors.forename: Paul R
authors.initials: PR
authors.lastname: Tarnasky
authors.affiliation: Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.
authors.forename: C Mel
authors.initials: CM
authors.lastname: Wilcox
authors.affiliation: Department of Medicine, Allegheny Center for Digestive Health, Pittsburgh, Pennsylvania.
authors.forename: Abhijit
authors.initials: A
authors.lastname: Kulkarni
authors.affiliation: Department of Radiology, Indiana University School of Medicine, Indianapolis, Indiana.
authors.forename: Alex M
authors.initials: AM
authors.lastname: Aisen
authors.affiliation: Repligen Corp, Waltham, Massachusetts.
authors.forename: David
authors.initials: D
authors.lastname: Jacoby
authors.affiliation: Department of Medicine, Virginia Mason Medical Center, Seattle, Washington.
authors.forename: Richard A
authors.initials: RA
authors.lastname: Kozarek
mesh_terms: D000208:Acute Disease; D000328:Adult; D002170:Canada; D002760:Cholangiopancreatography, Endoscopic Retrograde; D049448:Cholangiopancreatography, Magnetic Resonance; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D010183:Pancreatic Ducts / Q000473:pathology*; D010195:Pancreatitis / Q000175:diagnosis* / Q000473:pathology; D011237:Predictive Value of Tests; D011379:Prognosis; D011446:Prospective Studies; D012008:Recurrence; D012633:Secretin / Q000008:administration & dosage; D014481:United States
chemical_list: D012633:Secretin
keywords: Direct Comparison; Increasing Resolution; Pancreas; Peptide Hormone