A Pilot Study Evaluating Health-related Quality of Life Endpoints in Patients Undergoing Minimally Invasive Versus Open Pancreaticoduodenectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 主要终点
- Change in quality of life, as measured by FACT-Hep score
研究概览
简要总结
The purpose of this study is to evaluate the impact of the quality of life in patients undergoing the Whipple procedure (pancreaticoduodenectomy, PD) for pancreatic cancer. The Whipple procedure can be done by laparoscopic (small incisions) or an open procedure (large incision) to treat the patients cancer. The goal of this study is to see if there is any difference in quality of life between patients who undergo the laparoscopic or the open Whipple procedure. Surgical technique (minimally invasive versus open) will be at the discretion of the operating surgeon. Patients will not be randomized to a treatment arm.
A subset of these patients will also be asked to take part in a pre- and postoperative in-depth interview to explore the lived experiences of patients with resectable pancreatic cancer.
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 scheduled for pancreaticoduodenectomy will be eligible for this study.
- •Subject must be at least 18 years of age and at least the minimum Age of Majority according to applicable State or Country Law.
- •Subject is a suitable surgical candidate, i.e. is able to undergo general anesthesia and PD for diagnosis of cancer
- •Subject is willing and able to cooperate with survey participation.
- •Subject has been informed of the study procedures and the treatment and has signed an informed consent form
排除标准
- •Subject is not a suitable candidate for PD
结局指标
主要结局
Change in quality of life, as measured by FACT-Hep score
时间窗: Baseline (before surgery), at hospital discharge (up to approximately 14 days), at first clinic visit (within 2 weeks after discharge), 3 months
The summed overall FACT-Hep score (0-180) will be the primary outcome.
次要结局
未报告次要终点