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SpHincterotomy for Acute Recurrent Pancreatitis Randomized Trial: Rationale, Methodology, and Potential Implications
Gregory A Coté1, Valerie L Durkalski-Mauldin2, Jose Serrano3
1From the Department of Medicine.
Pancreas
|August 13, 2019
Summary
The SHARP trial investigates if minor papilla endoscopic sphincterotomy (miES) reduces acute pancreatitis in patients with pancreas divisum. This sham-controlled study aims to determine the effectiveness of miES for recurrent pancreatitis.
Area of Science:
- Gastroenterology
- Endoscopic procedures
- Clinical trials
Background:
- Acute recurrent pancreatitis (ARP) with pancreas divisum often leads to endoscopic retrograde cholangiopancreatography (ERCP) with minor papilla endoscopic sphincterotomy (miES).
- Limited data currently supports the efficacy of miES in managing ARP without other identifiable causes.
Purpose of the Study:
- To describe the rationale and methodology of the SpHincterotomy for Acute Recurrent Pancreatitis (SHARP) trial.
- To test the hypothesis that miES reduces the risk of acute pancreatitis in patients with ARP and pancreas divisum.
Main Methods:
- A multicenter, international, sham-controlled, randomized trial comparing endoscopic ultrasound with miES versus endoscopic ultrasound with sham.
- 234 patients with ARP and pancreas divisum, confirmed by magnetic resonance cholangiopancreatography, will be randomized.
- Follow-up duration ranges from 6 to 48 months.
Main Results:
- The trial is powered to detect a 33% risk reduction in acute pancreatitis frequency.
Conclusions:
- The SHARP trial will ascertain the benefits of ERCP with miES for patients experiencing idiopathic ARP and pancreas divisum.
- Blinded outcome assessment and long-term follow-up are crucial elements of the trial design.
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