Perioperative Outcomes of Robotic Approach for Pancreaticoduodenectomy: a Multi-center, Prospective, Single Arm, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 4
- 主要终点
- Length of hospital stay
研究概览
简要总结
This is a multi-site prospective, single arm, observational study examining the outcomes of robotic pancreaticoduodenectomy.
详细描述
This is a multi-site prospective, single arm, observational study examining the outcomes of robotic pancreaticoduodenectomy. Adult patients with symptomatic benign, premalignant, or resectable malignant pathologies recommended for resection after multidisciplinary review and have already chosen to have robotic surgery will be evaluated for enrolling into the study.
Relevant operative, postoperative, and pathologic outcomes will be collected prospectively. The well-established enhanced recovery after pancreaticoduodenectomy pathway currently used in our institution will be applied to all patients postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •≥18 years old
- •Symptomatic benign, premalignant, or resectable malignant periampullary and pancreatic tumor requiring resection
- •Fit to undergo elective pancreaticoduodenectomy after evaluation by the surgical and anesthesiology teams
- •Able to consent to participate in the study
- •Appropriate for robotic approach as determined by participating surgeons
排除标准
- •Arterial (superior mesenteric artery, celiac axis, hepatic artery) or venous involvement (superior mesenteric vein, portal vein) which meets the definition of borderline or unresectable tumor
- •Pregnancy
- •BMI >40 kg/m2
- •Patient requires an additional surgical resection during the index operation (such as hepatectomy or colectomy)
结局指标
主要结局
Length of hospital stay
时间窗: up to 90 days post intervention
Days from date of intervention to discharge
次要结局
- Number of participants experiencing complications(Day 90 post-intervention)
- Number of participants experiencing pancreaticoduodenectomy-specific complications(Day 90 post-intervention)
- Pathological outcomes as assessed by Pathological response to neoadjuvant therapy(Day 90-post intervention)
- Quality of life (QoL) as measured by EQ-5D-3L(EQ-5D-3L will be measured at 2 to 4 weeks and 3 to 6 months-post intervention.)
- Operative estimated blood loss(During the surgery)
- Survival Outcome(Overall survival is from surgery to last time of follow-up or death, assessed up to 60 months-post intervention.)
- Quality of life (QoL) as measured by QLQ-C30 (version 3)(QLQ-C30 will be measured at 2 to 4 weeks and 3 to 6 months-post intervention.)
- Exploratory outcomes(30 days after the surgery)
- Time to functional recovery(Day 1 post-intervention to functional recovery)