From the Department of Medicine.
Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.
Pancreas. 2019 Sep;48(8):1061-1067. doi: 10.1097/MPA.0000000000001370.
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.
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.
The trial is powered to detect a 33% risk reduction of acute pancreatitis frequency.
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.
在急性复发性胰腺炎（ARP）、胰腺分裂且无其他病因的患者中，基于有限的数据，常进行内镜逆行胰胆管造影术（ERCP）伴小乳头内镜下括约肌切开术（miES）以扩大小乳头开口。本研究旨在描述一项假手术对照临床试验的原理和方法，该试验旨在检验 miES 降低急性胰腺炎风险的假设。
SpHincterotomy for Acute Recurrent Pancreatitis（SHARP）试验是一项多中心、国际、假手术对照、随机临床试验，比较超声内镜+ERCP 伴 miES 与超声内镜+假手术治疗 ARP。共有 234 名同意参加的患者，他们有 2 次或以上离散的急性胰腺炎发作、磁共振胰胆管成像证实胰腺分裂，且无其他急性胰腺炎的明确病因，将进行随机分组。两组患者均至少随访 6 个月，最长随访 48 个月。
该试验具有发现急性胰腺炎频率降低 33%的效力。
SHARP 试验将确定 ERCP 伴 miES 是否对特发性 ARP 和胰腺分裂的患者有益。试验计划强调了盲法结局评估者和长期随访的重要性。
