Quality of Life Evaluation of Endoscopic Interventions in Chronic Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Change in Quality of Life using the PANQOLI (PANcreatitis Quality of Life Instrument)
研究概览
简要总结
This study seeks to evaluate the effect of endoscopic interventions on quality of life in patients with chronic pancreatitis. Quality of life will be evaluated using the PANQOLI, a validated quality of life instrument specific to chronic pancreatitis. Endoscopic interventions will include pancreatic duct dilation and stenting, celiac plexus block, lithotripsy and removal of pancreatic duct stones, and pseudocyst drainage.
详细描述
This is a multicenter prospective cohort study assessing the impact of endoscopic interventions on patients with chronic pancreatitis. Patients with chronic pancreatitis referred for endoscopic treatment, including pancreatic duct dilation and stenting, pseudocyst drainage, celiac plexus blocks, and pseudocyst drainage/necrosectomy will be enrolled in this study. They will receive a baseline evaluation using the PANQOLI, a chronic pancreatitis-specific quality of life instrument, in addition to a visual analog scale to measure their pain. Demographic and endoscopic features will be collected in addition to pain medication use. Patients will receive follow-up at 1, 3, and 6 months post-intervention consisting of the PANQOLI, visual analog scale for pain, and pain medication use.
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 with painful chronic pancreatitis, defined as either 1) the presence of pancreatic calcifications on cross-sectional imaging, 2) morphologic changes consistent with the Rosemont criteria on endoscopic ultrasound, or 3) endoscopic pancreatic function test results consistent with decreased pancreatic function.
排除标准
- •Pregnant females
- •Prisoners
- •Patients under the age of 18
- •Patients lacking the capacity to consent
结局指标
主要结局
Change in Quality of Life using the PANQOLI (PANcreatitis Quality of Life Instrument)
时间窗: The outcome will be measured at 1, 3, and 6 months post-intervention.
The primary outcome will be the change in quality of life using the PANQOLI (PANcreatitis Quality of Life Instrument) after endoscopic intervention.
次要结局
- Change in pain level using the Visual Analog Scale (VAS) for pain.(The outcome will be measured at 1, 3, and 6 months post-intervention.)
- Change in pain medication use(The outcome will be measured at 1, 3, and 6 months post-intervention.)