SpHincterotomy for Acute Recurrent Pancreatitis

乳头括约肌切开术治疗急性复发性胰腺炎

• 批准号: 10469267
• 负责人: Gregory A Cote
• 金额: $ 196.01万
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-03 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10469267
• 关键词: Achievement; Acute; Address; Aftercare; Anatomy; Biological; Blinded; Canada; Clinical Trials Data Monitoring Committees; Clinical Trials Design; Data; Development; Diabetes Mellitus; Disease; Dorsal; Drainage procedure; Early Intervention; Endoscopic Retrograde Cholangiopancreatography; Endoscopic Sphincterotomy; Endoscopic Ultrasonography; Enrollment; Etiology; Event; Feedback; Frequencies; Future; General Population; Goals; Grant; Hospitalization; Impairment; Incidence; Intervention; Laboratories; MRI Scans; Magnetic Resonance; Magnetic Resonance Imaging; Malignant neoplasm of pancreas; Measures; Minor; Morphology; Mutation; Natural History; Netherlands; Obstruction; Outcome; Outcome Assessment; Outcome Measure; Outcome Study; Pain; Pancreas; Pancreatic duct; Pancreatitis; Pathogenicity; Patient Care; Patient-Focused Outcomes; Patients; Peer Review; Perceived quality of life; Persons; Predisposition; Principal Investigator; Procedures; Protocols documentation; Quality of life; Radiology Specialty; Randomized; Recurrence; Retrospective cohort study; Risk; Risk Factors; Role; Sample Size; Sampling; Secretin; Single-Blind Study; Stenosis; Testing; Therapeutic; Time; acute pancreatitis; base; biobank; burden of illness; chronic pancreatitis; clinical care; cohort; data repository; disability; disease natural history; efficacy evaluation; follow-up; gastrointestinal; genetic analysis; high risk; high risk population; imaging study; impression; improved; instrument; novel; pressure; primary outcome; randomized trial; response; secondary outcome; sham-controlled study; tongue papilla; treatment arm; treatment group

Project summary Acute pancreatitis is among the most common gastrointestinal causes for hospitalization in the U.S. Roughly one in five patients with acute pancreatitis will have recurrent bouts. Recurrent acute pancreatitis (RAP) is a strong risk factor for progression to chronic pancreatitis, an irreversible fibroinflammatory disease that greatly impacts quality of life, and is also a risk factor for pancreatic cancer. Increased intraductal pressure is an accepted cause for precipitating an episode of acute pancreatitis. Pancreas divisum, seen in 7-10% of the general population, occurs when the dorsal and ventral pancreatic ducts have incomplete or nonexistent fusion during early embryologic development. Using this rationale, endoscopists often perform endoscopic retrograde cholangiopancreatography (ERCP) with minor papilla sphincterotomy (miES) in patients who have idiopathic RAP (iRAP) and pancreas divisum with a goal to reduce subsequent attack(s). This practice remains highly controversial, due to major limitations in the available data which are derived almost exclusively from small, retrospective cohort studies with inconsistent and subjective outcomes. This is one of the highest risk indications for ERCP, having post-ERCP pancreatitis rates of 10-20%. A full scale, well-designed clinical trial with adequate follow-up and blinded treatment allocation is clearly needed to empirically evaluate the efficacy of miES in the setting of iRAP and pancreas divisum, including quantifying the cumulative benefit of this intervention on disease burden and to study its relationship with its natural history. The SpHincterotomy for Acute Recurrent Pancreatitis (SHARP) trial is a sham-controlled, single blind with a blinded outcome assessment, randomized trial evaluating the impact of miES on the natural history of iRAP in patients with pancreas divisum. The primary outcome is reducing the risk of subsequent acute pancreatitis (time-to-event), with secondary outcome measures being the change in incidence rate of attacks, patient-centered outcomes, and progression to chronic pancreatitis. By having an adequate sample size to measure the benefit of ERCP, we will be able to definitively establish the therapeutic role of ERCP in patients with iRAP and pancreas divisum. A biorepository will be established for future exploratory studies of novel risk factors for RAP, progression to chronic pancreatitis and its sequelae, and factors associated with response to miES. Patients fulfilling the entry criteria but refusing enrollment into the randomized trial will be enrolled into an observational cohort. Irrespective of the outcome, this study will have an immediate impact on patient care by confirming or refuting the therapeutic role of ERCP in patients with iRAP and pancreas divisum. !

项目概要 急性胰腺炎是美国住院最常见的胃肠道原因之一。 大约五分之一的急性胰腺炎患者会反复发作。复发性急性胰腺炎（RAP） 是进展为慢性胰腺炎的一个强烈危险因素，慢性胰腺炎是一种不可逆的纤维炎症性疾病， 影响生活质量，也是胰腺癌的危险因素。导管内压力增加是 公认的诱发急性胰腺炎发作的原因。胰腺分裂，见于 7-10% 一般人群，当背侧和腹侧胰管融合不完全或不存在时发生 在早期胚胎发育期间。利用这一原理，内窥镜医师经常进行内窥镜逆行手术 特发性胆胰管造影 (ERCP) 联合小乳头括约肌切开术 (mES) RAP (iRAP) 和胰腺分裂，目标是减少后续攻击。这种做法至今仍被高度重视 由于可用数据的主要局限性，这些数据几乎完全来自小规模、 回顾性队列研究的结果不一致且主观。这是风险最高的迹象之一 对于 ERCP，ERCP 后胰腺炎的发生率为 10-20%。一项全面、精心设计的临床试验，具有足够的 显然需要随访和盲法治疗分配来凭经验评估 miES 在 iRAP 和胰腺分裂的设置，包括量化这种干预措施对疾病的累积效益 负担并研究其与其自然历史的关系。 括约肌切开术治疗急性复发性胰腺炎 (SHARP) 试验是一项假手术对照、单盲试验 通过盲法结果评估，随机试验评估 miES 对自然史的影响 胰腺分裂患者的 iRAP。主要结果是降低随后急性发作的风险 胰腺炎（事件发生时间），次要结果指标是发作率的变化， 以患者为中心的结果以及慢性胰腺炎的进展。通过拥有足够的样本量 衡量 ERCP 的益处，我们将能够明确确定 ERCP 对患者的治疗作用 与 iRAP 和胰腺分裂。将建立一个生物样本库，用于未来新风险的探索性研究 RAP 的影响因素、进展为慢性胰腺炎及其后遗症以及与治疗反应相关的因素 米ES。符合入选标准但拒绝参加随机试验的患者将被纳入随机试验 观察队列。无论结果如何，这项研究都将对患者护理产生直接影响 证实或反驳 ERCP 对 iRAP 和胰腺分裂患者的治疗作用。 ！