Administration of Secretin (RG1068) Increases the Sensitivity of Detection of Duct Abnormalities by Magnetic Resonance Cholangiopancreatography in Patients With Pancreatitis

• Published in: Gastroenterology (New York, N.Y. 1943) Vol. 147; no. 3; pp. 646 - 654.e2
• Main Authors: Sherman, Stuart, Freeman, Martin L, Tarnasky, Paul R, Wilcox, C. Mel, Kulkarni, Abhijit, Aisen, Alex M, Jacoby, David, Kozarek, Richard A
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.09.2014
• Subjects: Acute Disease; Adult; Canada; Cholangiopancreatography, Endoscopic Retrograde; Cholangiopancreatography, Magnetic Resonance; Direct Comparison; Female; Gastroenterology and Hepatology; Humans; Increasing Resolution; Infusions, Intravenous; Male; Middle Aged; Pancreas; Pancreatic Ducts - pathology; Pancreatitis - diagnosis; Pancreatitis - pathology; Peptide Hormone; Predictive Value of Tests; Prognosis; Prospective Studies; Recurrence; Secretin - administration & dosage; United States; Canada; United States; computed tomography; MPD; EUS; magnetic resonance imaging; AE; MRI; Direct Comparison; Increasing Resolution; adverse event; S-MRCP; endoscopic retrograde cholangiopancreatography; main pancreatic duct; CT; endoscopic ultrasonography; MRCP; secretin-stimulated magnetic resonance cholangiopancreatography; SAE; serious adverse event; ERCP; Pancreas; magnetic resonance cholangiopancreatography; Peptide Hormone
• ISSN: 0016-5085; 1528-0012
• DOI: 10.1053/j.gastro.2014.05.035

Background & Aims 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 ).