Robot-assisted Versus Open Lateral Pancreaticojejunostomy for the Treatment of Symptomatic Chronic Pancreatitis (PANACOTTA): a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Quality of Recovery (QoR-15)
研究概览
简要总结
PANACOTTA is a multicenter randomized controlled trial including patients with symptomatic chronic pancreatitis and a dilated main pancreatic duct to either robot-assisted or open lateral pancreaticojejunostomy. The PANACOTTA trial will assess the post-operative quality of recovery following robot-assisted versus open lateral pancreaticojejunostomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Patient-blinded up to post-operative day 5.
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
- •At least 18 years old
- •Indication for (extended or partial) lateral pancreaticojejunostomy as agreed during multidisciplinary team meeting based on symptomatic chronic pancreatitis (i.e. morphine dependent pain or recurrent acute flares of pancreatitis, at least 3 episodes per year) and a dilated pancreatic duct of ≥ 5 mm, with a non-enlarged pancreatic head < 40 mm
- •Confirmed CP, according to the M-ANNHEIM diagnostic Criteria24
- •Eligible for both an robot-assisted and open approach
- •Obtained written informed consent
排除标准
- •Suspected or confirmed current pancreatic cancer
- •ASA classification ≥ 4
- •Other painful conditions aside from CP, with pain difficult to discriminate from CP pain
- •Prior pancreatic surgery
- •Pregnancy
研究组 & 干预措施
Robot-assisted lateral pancreaticojejunostomy
干预措施: Robot-assisted lateral pancreaticojejunostomy (Procedure)
Open lateral pancreaticojejunostomy
干预措施: Open lateral pancreaticojejunostomy (Procedure)
结局指标
主要结局
Quality of Recovery (QoR-15)
时间窗: Daily assessments on Post-operative Day 1 through Day 5 and up to time of functional recovery, defined individually per patient (maximum of 90 days from surgery).
Primary objective: To assess post-operative mean Quality of Recovery (QoR-15) on post-operative days one through five and cumulative loss of QoR-15 until time of functional recovery of robot-assisted (RA) as compared to open lateral pancreaticojejunostomy (LPJ) in patients with symptomatic chronic pancreatitis and a dilated main pancreatic duct with a normal size pancreatic head.
次要结局
未报告次要终点
研究者
M.G. Besselink
M.G. Besselink
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)