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SpHincterotomy for Acute Recurrent Pancreatitis Randomized Trial: Rationale, Methodology, and Potential Implications
- Source :
- Pancreas, Pancreas, 48, 8, pp. 1061-1067, Pancreas, 48, 1061-1067
- Publication Year :
- 2019
-
Abstract
- Contains fulltext : 215317.pdf (Publisher’s version ) (Closed access) OBJECTIVES: In patients with acute recurrent pancreatitis (ARP), pancreas divisum, and no other etiologic factors, endoscopic retrograde cholangiopancreatography (ERCP) with minor papilla endoscopic sphincterotomy (miES) is often performed to enlarge the minor papillary orifice, based on limited data. The aims of this study are to describe the rationale and methodology of a sham-controlled clinical trial designed to test the hypothesis that miES reduces the risk of acute pancreatitis. METHODS: The SpHincterotomy for Acute Recurrent Pancreatitis (SHARP) trial is a multicenter, international, sham-controlled, randomized trial comparing endoscopic ultrasound + ERCP with miES versus endoscopic ultrasound + sham for the management of ARP. A total of 234 consented patients having 2 or more discrete episodes of acute pancreatitis, pancreas divisum confirmed by magnetic resonance cholangiopancreatography, and no other clear etiology for acute pancreatitis will be randomized. Both cohorts will be followed for a minimum of 6 months and a maximum of 48 months. RESULTS: The trial is powered to detect a 33% risk reduction of acute pancreatitis frequency. CONCLUSIONS: The SHARP trial will determine whether ERCP with miES benefits patients with idiopathic ARP and pancreas divisum. Trial planning has informed the importance of blinded outcome assessors and long-term follow-up.
- Subjects :
- Endoscopic ultrasound
Adult
Male
medicine.medical_specialty
Internationality
Cholangiopancreatography, Magnetic Resonance
Endocrinology, Diabetes and Metabolism
Other Research Radboud Institute for Molecular Life Sciences [Radboudumc 0]
Article
law.invention
Endosonography
Cohort Studies
03 medical and health sciences
Sphincterotomy, Endoscopic
0302 clinical medicine
Endocrinology
Randomized controlled trial
law
Recurrence
Risk Factors
Outcome Assessment, Health Care
Internal Medicine
medicine
Secondary Prevention
Humans
Pancreas
Cholangiopancreatography, Endoscopic Retrograde
Magnetic resonance cholangiopancreatography
Pancreas divisum
Endoscopic retrograde cholangiopancreatography
Hepatology
medicine.diagnostic_test
business.industry
medicine.disease
Surgery
Clinical trial
Pancreatitis
030220 oncology & carcinogenesis
Acute pancreatitis
030211 gastroenterology & hepatology
Female
business
Cohort study
Subjects
Details
- Language :
- English
- ISSN :
- 08853177
- Database :
- OpenAIRE
- Journal :
- Pancreas, Pancreas, 48, 8, pp. 1061-1067, Pancreas, 48, 1061-1067
- Accession number :
- edsair.doi.dedup.....ea13577890cd695eb60656551f096158