A Pilot Study in Endoscopic Therapy on Quality of Life and Pain in Chronic Pancreatitis: The EQuiPP Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Chronic Pancreatitis-Specific Quality of Life
研究概览
简要总结
This study is a prospective study designed to assess the effect of pancreatic endotherapy on quality of life, pain levels, pancreatic exocrine function, and endocrine function.
详细描述
Pancreatic endotherapy represents a potential treatment modality for patients with painful chronic pancreatitis. While pancreatic endotherapy is commonly performed, the effect of chronic pancreatitis on patient-centered outcomes remains poorly studied. Furthermore, the effect of endotherapy on pancreatic endocrine and exocrine are largely unknown. This study therefore aims to prospective observe patients with chronic pancreatitis after endotherapy is performed to better understand how it affects patient-centered outcomes such as pain and quality of life and pancreatic function. In doing so, the study also hopes to be able to predict which patients with chronic pancreatitis will benefit from pancreatic endotherapy.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic Pancreatitis (as defined by the American Pancreatic Association Guidelines)
- •Presence of Pain
- •Referred for pancreatic endotherapy
排除标准
- •Prior pancreatic endotherapy
- •Prior pancreatic surgery
- •Pregnant females
- •Subjects unable to consent
- •Imprisoned individuals
结局指标
主要结局
Chronic Pancreatitis-Specific Quality of Life
时间窗: 12 months post-completion of endotherapy
Quality of life will be primarily assessed using the PANcreatitis Quality of Life Instrument (PANQOLI). Quality of life will be assessed before and after endotherapy (1, 3, 6, and 12 months). This instrument is based on a 0-87 scale with higher scores representing improved quality of life.
Feasibility of Micro-Longitudinal Daily Pain Assessment
时间窗: 30-day post-procedure period
Pain will be assessed using daily pain diaries with the Brief Pain Inventory (BPI). These will be utilized to create short-term pain trajectories for subjects at baseline and post-procedure. This pain inventory includes 9 pain items graded on 0-10 scale with 10 being the worst pain.
次要结局
- Change in Self-Efficacy(12 months post-completion of endotherapy)
- Overall Quality of Life(12 months post-completion of endotherapy)
- Change in Nociceptive Pain(12 months post-completion of endotherapy)
- Change in Pain Catastrophizing(12 months post-completion of endotherapy)
- Pancreatic Endocrine Function via HbA1c(12 months post-completion of endotherapy)
- Insulin Sensitivity(12 months post-completion of endotherapy)
- Change in Chronic Pancreatitis-specific Pain(12 months post-completion of endotherapy)
- Change in Neuropathic Pain(12 months post-completion of endotherapy)
- Quantitative Sensory Testing(The quantitative sensory testing will be assessed only once during the subject's baseline enrollment.)
- Pancreatic Exocrine Function(12 months post-completion of endotherapy)
- Insulin Resistance(12 months post-completion of endotherapy)
研究者
Mitchell Ramsey
Assistant Professor
Ohio State University