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Gastroenterology. 2014 Sep;147(3):646-654.e2. doi: 10.1053/j.gastro.2014.05.035. Epub 2014 Jun 4.

Administration of secretin (RG1068) increases the sensitivity of detection of duct abnormalities by magnetic resonance cholangiopancreatography in patients with pancreatitis.

Author information

1
Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana. Electronic address: ssherman@iupui.edu.
2
Department of Medicine, University of Minnesota, Minneapolis, Minnesota.
3
Department of Medicine, Methodist Medical Center, Dallas, Texas.
4
Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.
5
Department of Medicine, Allegheny Center for Digestive Health, Pittsburgh, Pennsylvania.
6
Department of Radiology, Indiana University School of Medicine, Indianapolis, Indiana.
7
Repligen Corp, Waltham, Massachusetts.
8
Department of Medicine, Virginia Mason Medical Center, Seattle, Washington.

Abstract

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).

KEYWORDS:

Direct Comparison; Increasing Resolution; Pancreas; Peptide Hormone

PMID:
24906040
DOI:
10.1053/j.gastro.2014.05.035
[Indexed for MEDLINE]

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