SpHincterotomy for Acute Recurrent Pancreatitis Randomized Trial

Abstract

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 shamcontrolled 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 vs. endoscopic ultrasound + sham for the management of ARP. A total of 234 consented patients having two 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 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.

Pancreatitis in Children

“…Children with PD undergo multiple endoscopic procedures, pancreatic sphincterotomy, or minor papillotomy, but endoscopic retrograde cholangiopancreatography (ERCP) has been found helpful only when pancreatic ductal stones are present. 37 Similar to the newly launched Sphincterotomy for Acute Recurrent Pancreatitis trial in adults, 40 it will be important to examine in a randomized fashion whether children with ARP and pancreas divisum truly benefit from the intervention of minor sphincterotomy. Other pancreas anomalies associated with pancreatitis are pancreaticobiliary malunion, choledochal cyst, and annular pancreas.…”

Rationale and Design for the Diabetes RElated to Acute Pancreatitis and Its Mechanisms Study

“…This manual will be updated on an as-needed basis to address common questions or recurring situations where clarifying information is needed. We sought guidance from T1DAPC investigators and the NIH representatives participating in recent and ongoing studies in pancreatitis to refine, and when possible harmonize, study definitions, data elements, case report forms, and research methodology 21–25 . Lastly, we have convened a recruitment and retention committee concurrently with study planning to provide guidance and feedback regarding implications of decisions on participant burden 26 .…”

“…We sought guidance from T1DAPC investigators and the NIH representatives participating in recent and ongoing studies in pancreatitis to refine, and when possible harmonize, study definitions, data elements, case report forms, and research methodology. [21][22][23][24][25] Lastly, we have convened a recruitment and retention committee concurrently with study planning to provide guidance and feedback regarding implications of decisions on participant burden. 26 There is not a precedent in the United States for a prospective cohort study in AP of this scale, so we will prospectively monitor recruitment and retention rates, completion of study assessments, and collaboratively discuss any needs to alter the sample size, number, and/or frequency of study assessments to maintain feasibility.…”

Recruitment and Retention Strategies for the Diabetes RElated to Acute Pancreatitis and Its Mechanisms Study

“…5 Most previous clinical studies in AP were designed to assess inpatient and short interval outpatient outcomes such as organ failure, infected pancreatic necrosis, or mortality. 8,9 To date, few prospective cohort studies in pancreatitis have been designed with comprehensive long-term assessments, protocol-mandated evaluations, and rigorous biological sample collections, [10][11][12][13][14][15] but most were endoscopically driven with short-term follow-up, and only one reported retention rate of 77% at 12-month follow-up. Participation of many T1DAPC investigators in the design and execu-tion of prior studies offers important "lessons learned" from struggles with recruitment and/or retention.…”