24906040
OBJECTIVE	Administration of secretin improves noninvasive imaging of the pancreatic duct with magnetic resonance cholangiopancreatography ( MRCP ) .
OBJECTIVE	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 .
METHODS	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 .
METHODS	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 .
METHODS	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 .
RESULTS	Pancreatic duct abnormalities were observed in 60.2 % of ERCP images .
RESULTS	All radiologists identified duct abnormalities in RG1068-cin MRCP image sets with significantly higher levels of sensitivity ( P < .0001 ) than in images from MRCP , with minimal loss of specificity .
RESULTS	Adverse events were reported in 38.0 % of patients after MRCP and 68.1 % after ERCP .
RESULTS	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 .
RESULTS	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 .
CONCLUSIONS	RG1068-enhanced MRCP might also better identify patients in need of therapeutic ERCP ( ClinicalTrials.gov , Number : NCT00660335 ) .

