A Prospective Cohort Study Evaluating PAN-PROMISE, a Patient-Reported Outcome Measure, To Detect and Risk-Stratify Post-ERCP Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- PROM-PEP
研究概览
简要总结
The aim of this study is to use a validated patient-reported outcome measure to evaluate how many patients have symptoms of pancreatitis after ERCP and how it correlates with their quality of life and productivity.
详细描述
This project will measure the impact of a recently validated patient-reported outcome measure for acute pancreatitis, PAN-PROMISE, to detect post-ERCP pancreatitis symptoms and capture its morbidity. The study will compare the change of PAN-PROMISE before and after ERCP to the current standard diagnostic criteria for post-ERCP pancreatitis, the Cotton Consensus Criteria. The main limitations of the Cotton-Consensus Criteria are that it fails to capture outpatient or ambulatory morbidity, uses length of stay to define the severity of pancreatitis without accounting for local or systemic complications for pancreatitis, and it has limited sensitivity in patients with chronic symptoms such as patients with chronic pancreatitis or pancreatic adenocarcinoma. These limitations have impeded the evaluation of potential therapies to prevent post-ERCP pancreatitis. PAN-PROMISE will help capture and quantitate the morbidity related to post-ERCP pancreatitis and thus will enhance our ability to optimize outcomes following ERCP.
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
- •Patients undergoing ERCP
- •Age >= 18 years old
- •Intact major papilla
排除标准
- •Unwillingness or inability to consent for the study
- •Age < 18 years
- •Standard contraindications to ERCP
- •Intrauterine pregnancy
- •Prior hepaticojejunostomy in a patient undergoing ERCP for a bile duct indication
- •Prior pancreaticojejunostomy in a patient undergoing ERCP for a pancreatic duct indication
- •Low probability of completing the follow-up
- •Acute pancreatitis (by the Revised Atlanta criteria) in the seven days prior to ERCP.
- •Patients who do not answer at least 80% of the questions on the baseline and 48-hour follow-up survey.
- •Patients who could not be contacted via a telephone call to assess for post-ERCP complications at 48-72 hours.
- •Patients who speak a language other than English, Spanish, Bulgarian, Mandarin, English, French, German, Greek, Hungarian, Italian, Korean, Polish, Portuguese, Romanian, Russian, Turkish, Ukrainian, or Hindi (as the PAN-PROMISE has only been translated and validated in these languages.
结局指标
主要结局
PROM-PEP
时间窗: 30 days
will capture the work abseentism and loss of productivity using the Work-Productivity and Activity Impairment Questionnaire and will express in in 2021 US Dollars.
Post-ERCP Pancreatitis
时间窗: 7 days after ERCP
will define post-ERCP pancreatitis using the Cotton Consensus Criteria with a 3 physician adjudication committee.
次要结局
- Direct Health Care Costs(30 days)