Advancing Treatment for Pancreatitis: A Prospective Observational Study of TPIAT (POST)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 433
- 试验地点
- 12
- 主要终点
- Quality of Life
研究概览
简要总结
Multi-center, prospective, observational cohort study of patients undergoing total pancreatectomy with islet autotransplantation (TPIAT)
详细描述
Patients who are undergoing TPIAT at one of the participating center are invited to participate in this observational study, with 450 participants anticipated. The aims of the study are:
Aim 1: To determine (1a) whether patient and disease characteristics are associated with favorable pain and health-related quality-of-life outcomes (HRQOL) after TPIAT; (1b) the optimal timing of the TPIAT intervention to resolve pain and improve HRQOL; and (1c) in a subset of patients, the impact of central sensitization on pain resolution.
Aim 2: To determine (2a) whether patient and disease characteristics are associated with favorable glycemic outcomes from the IAT procedure; and (2b) the optimal timing of TPIAT to obtain post-surgical insulin independence.
Aim 3: To determine the cost-effectiveness of TPIAT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Any patient with chronic or recurrent acute pancreatitis undergoing total or completion pancreatectomy with islet autotransplantation at a participating center.
排除标准
- •Partial pancreatectomy
- •TPIAT performed for a diagnosis other than chronic or recurrent acute pancreatitis (for example benign or malignant pancreatic tumor)
研究组 & 干预措施
TPIAT
patients undergoing total pancreatectomy with islet autotransplant.
干预措施: TPIAT (Procedure)
结局指标
主要结局
Quality of Life
时间窗: Mos 6, Years 1, 2, 3, 4 after surgery
Physical Component Summary Score from SF-12
Diabetes
时间窗: Mos 6, Years 1, 2, 3, 4 after surgery
Proportion of patients insulin independent
Pain Reduction
时间窗: Mos 6, Years 1, 2, 3, 4 after surgery
Visual Analog Pain Scale
次要结局
- Opioid Use(Mos 6, Years 1, 2, 3, 4 after surgery)
- Insulin Dose(Mos 6, Years 1, 2, 3, 4 after surgery)
- Islet Graft Function(Mos 6, Years 1, 2, 3, 4 after surgery)
- Severe Hypoglycemia Episodes(Mos 6, Years 1, 2, 3, 4 after surgery)
- Glycemic Control(Mos 6, Years 1, 2, 3, 4 after surgery)
- Pain Interference(Mos 6, Years 1, 2, 3, 4 after surgery)