NCT05788029Enrolling By Invitation不适用
Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- length of hospital stay
研究概览
简要总结
The aim of this study was to evaluate the outcomes of LPD versus OPD in non-pancreatic periampullary adenocarcinoma
详细描述
The aim of this study was to evaluate the outcomes of LPD versus OPD in non-pancreatic periampullary adenocarcinoma
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 years and 75 years.
- •Histologically confirmed NPPC or clinically diagnosed NPPC by an MDT without histopathologic evidence.
- •Patients feasible to undergo both LPD and OPD ac- cording to MDT evaluations.
- •Patients understanding and willing to comply with this trial.
- •Provision of written informed consent before patient registration.
- •Patients meeting the curative treatment intent in ac- cordance with clinical guidelines.
排除标准
- •Patients with distant metastases, including peritone- al, liver, distant lymph node metastases and involve- ment of other organs.
- •Patients requiring left, central or total pancreatecto- my or other palliative surgery.
- •Preoperative American Society of Anaesthesiologists (ASA) score ≥
- •History of other malignant disease
- •Pregnant or breastfeeding women.
- •Patients with serious mental disorders
- •Patients treated with neoadjuvant therapy.
- •Patients with vascular invasion and requiring vascular resection as evaluated by the MDT team according to abdominal imaging data.
- •Body mass index >35 kg/m 2 .
- •Patients participating in any other clinical trials with- in 3 months.
研究组 & 干预措施
laparoscopic pancreaticoduodenectomy
Experimental
laparoscopic pancreaticoduodenectomy
干预措施: laparoscopic pancreaticoduodenectomy (Procedure)
open pancreaticoduodenectomy
Active Comparator
open pancreaticoduodenectomy
干预措施: open pancreaticoduodenectomy (Procedure)
结局指标
主要结局
length of hospital stay
时间窗: 90 days
defined as the number of nights spent in the hospital from the end of the surgical procedure until discharge or death
次要结局
- 1 year OS(1 year)
- mortality(90 days)
- morbidity(90 days)
研究者
研究点 (1)
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