Registry of Endoscopic Ultrasound (EUS) Evaluation and Management of Pancreatic Fluid Collections and Pancreatic Cysts
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- AdventHealth
- 试验地点
- 1
- 主要终点
- Treatment success in patients with pancreatic fluid collections following endoscopic interventions
研究概览
简要总结
This registry aims to assess the outcomes of patients undergoing EUS-guided interventions of pancreatic fluid collections and EUS examination of pancreatic cyst lesions.
详细描述
For pancreatic fluid collections, data included in this registry are 292 variables on patient demographics (age, gender, race), symptoms at presentation, severity of disease prior to intervention, indications for undergoing endoscopic intervention, details of the pancreatic fluid collections on cross-sectional imaging and EUS, review of laboratory results, review of imaging, details of interventions performed for pancreatic fluid collections, clinical details following intervention, adverse events from interventions and pancreatitis/pancreatic fluid collections, interventions for any adverse events, response to treatment of pancreatic fluid collections including any hospital readmissions, recurrence of pancreatic fluid collections, need for repeat interventions for pancreatic fluid collections, details of pancreatic duct integrity such as the presence of disconnected pancreatic duct syndrome, and clinical status at follow-up.
For pancreatic cysts, data included in this registry are 60 variables on patient demographics (age, gender, race), symptoms at presentation, imaging modality performed to detect the cyst, features of the cyst on EUS, features of the main pancreatic duct on EUS, technical details of EUS-guided sampling of the cystic fluid, results of cyst fluid analysis including cytology, tumor markers, amylase levels, molecular markers, final diagnosis of the cyst on follow-up, details of any follow up evaluation performed, details of repeat examinations performed and details of any treatment performed for the pancreatic cyst.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients aged 18 years or over, who are undergoing EUS evaluation of a pancreatic cyst lesion or endoscopy-based (EUS-guided) interventions for pancreatic fluid collection at the Center for Interventional Endoscopy will be included in this registry.
- •Exclusion Criteria
- •Age less than 18 years
- •No pancreatic cyst on EUS examination or no pancreatic fluid collection amenable to endoscopic drainage on EUS examination
排除标准
- 未提供
结局指标
主要结局
Treatment success in patients with pancreatic fluid collections following endoscopic interventions
时间窗: 6 months (minimum)
The treatment success of a structured, algorithmic approach to the management of pancreatic fluid collections will be evaluated. Structured approach involves management strategies based on the type (pseudocyst vs. necrosis), size, number, location of the pancreatic fluid collection, degree of necrosis, need for adjunctive percutaneous drain placement, and presence of disconnected pancreatic duct syndrome.
Natural history and disease progression in pancreatic cysts
时间窗: 6 months (minimum) to 5 years
The relationship between patient characteristics, clinical symptoms, cyst and pancreatic duct characteristics on cross-sectional imaging and on EUS examination, results of cyst sampling (including cytology, tumor markers, amylase, molecular markers) and final diagnosis on follow-up with be determined.
次要结局
- Number of interventions required for treatment success in patients with pancreatic fluid collections(6 months (minimum))
- Treatment failure in patients with pancreatic fluid collections(6 months (minimum) to 5 years)
- Adverse events in patients undergoing EUS-guided drainage of pancreatic fluid collections(6 months (minimum) to 5 years)
- Impact of disconnected pancreatic duct syndrome in patients undergoing EUS-guided drainage of pancreatic fluid collections(6 months (minimum) to 5 years)
- Impact of placement of long-term plastic transmural stents in patients with pancreatic fluid collections and disconnected pancreatic duct syndrome(6 months (minimum) to 5 years)
- Treatment success in patients with pancreatic fluid collections undergoing a structured approach to endoscopic necrosectomy following EUS-guided drainage of pancreatic fluid collections(6 months (minimum) to 5 years)
- Recurrence of pancreatic fluid collections in patients undergoing EUS-guided drainage of pancreatic fluid collections(6 months (minimum) to 5 years)
- Hospital admissions and reinterventions in patients undergoing EUS-guided drainage of pancreatic fluid collections(6 months (minimum) to 5 years)
- Evaluate the role of plastic stents in patients undergoing EUS-guided drainage of pancreatic fluid collections.(6 months (minimum) to 5 years)