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: 9495849
• 负责人: Gregory A Cote
• 金额: $ 129.33万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9495849
• 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; 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; Ultrasonography; acute pancreatitis; base; biobank; burden of illness; chronic pancreatitis; clinical care; cohort; data warehouse; disability; disease natural history; 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. !

项目总结 急性胰腺炎是美国住院治疗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 是进展为慢性胰腺炎的强烈危险因素，这是一种不可逆转的纤维炎性疾病，在很大程度上 影响生活质量，也是胰腺癌的危险因素。导管内压升高是一种 引发急性胰腺炎的公认原因。胰腺分裂，见于7%-10%的 一般人群，当背侧和腹侧胰管融合不完全或不存在时发生 在早期胚胎发育过程中。根据这一原理，内窥镜医生经常进行内窥镜逆行手术 特发性乳头括约肌小切开术的胰胆管造影术 RAP(IRAP)和胰腺分裂，目的是减少后续攻击(S)。这种做法仍然非常普遍 有争议的是，由于可用数据的主要限制，这些数据几乎完全来自小的， 具有不一致和主观结果的回溯性队列研究。这是风险最高的迹象之一。 ERCP术后胰腺炎发生率为10-20%。全面、精心设计的临床试验，有足够的 显然需要随访和盲法治疗分配来经验性地评估MIES在 IRAP和胰腺分裂的设定，包括量化这种干预对疾病的累积益处 并研究其与自然历史的关系。 乳头括约肌切开术治疗急性复发性胰腺炎(SHARP)试验是一项假对照单盲试验 用盲法结果评估，随机试验评估MIES对人类自然历史的影响 胰腺分裂患者的IRAP治疗。主要结果是降低了随后发生急性胰腺炎的风险 胰腺炎(事件发生时间)，次要结果指标是发作发生率的变化， 以患者为中心的结果，并进展为慢性胰腺炎。通过拥有足够的样本量来 衡量ERCP的益处，我们将能够明确确定ERCP在患者中的治疗作用 使用iRAP和胰腺分裂。将建立一个生物库，用于未来对新风险的探索性研究 RAP、进展为慢性胰腺炎及其后遗症的因素，以及与反应相关的因素 密斯。符合入选标准但拒绝参加随机试验的患者将被纳入 观察队列。无论结果如何，这项研究都将对患者护理产生立竿见影的影响 肯定或否定ERCP在iRAP合并胰腺分裂患者中的治疗作用。 好了！