Modified "Single-Incision Plus One "Versus Conventional "Five-Port" Laparoscopic Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas: Study Protocol for A Multicentre Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 232
- 试验地点
- 4
- 主要终点
- Overall Survival Rate at 1 Year After Surgery
研究概览
简要总结
This multicenter, randomized, controlled, non-inferiority trial will compare modified single-incision plus one-port laparoscopic pancreaticoduodenectomy (mSILPD+1) with conventional five-port laparoscopic pancreaticoduodenectomy (CLPD) in adults with histologically confirmed or highly suspected non-pancreatic periampullary carcinoma who are candidates for pancreaticoduodenectomy. A total of 232 participants will be randomly assigned in a 1:1 ratio. Outcome assessors who adjudicate complications and interpret imaging will be masked to treatment assignment. The primary outcomes are all-cause mortality within 90 days after surgery and overall survival at 1 year after surgery. Secondary outcomes will assess postoperative complications, surgical performance, postoperative recovery, disease-free survival, quality of life, and health-care costs.
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 18 years or older and younger than 75 years.
- •Histopathologically confirmed non-pancreatic periampullary carcinoma, or a high clinical suspicion of non-pancreatic periampullary carcinoma when preoperative pathological confirmation is unavailable.
- •Determined by preoperative multidisciplinary team evaluation to require pancreaticoduodenectomy.
- •Able to understand and comply with study procedures.
- •Able and willing to provide written informed consent before any study-specific screening procedure.
- •Expected to benefit from therapeutic pancreaticoduodenectomy according to applicable clinical guidelines.
排除标准
- •Distant metastasis, including peritoneal, hepatic, distant lymph node, or other organ metastasis.
- •Requirement for distal, central, or total pancreatectomy, or another palliative procedure.
- •Preoperative American Society of Anesthesiologists physical status classification of 4 or higher.
- •Concurrent malignancy other than the target cancer.
- •Pregnancy or breastfeeding.
- •Severe psychiatric disorder that would interfere with study participation.
- •Receipt of neoadjuvant chemotherapy or radiotherapy before surgery.
- •Vascular invasion requiring vascular resection, as determined by the multidisciplinary team based on preoperative abdominal imaging.
- •Body mass index greater than 35 kg/m².
- •Participation in another clinical trial within the previous 3 months.
结局指标
主要结局
Overall Survival Rate at 1 Year After Surgery
时间窗: From the date of surgery to 1 year after surgery
All-Cause Mortality Within 90 Days After Surgery
时间窗: From surgery through 90 days after surgery
次要结局
- Overall Postoperative Complication Rate Within 30 Days(From surgery through 30 days after surgery)
- R0 Resection Rate(At final postoperative pathological assessment, up to 30 days after surgery)
- Operative Time(During the index surgery)
- Disease-Free Survival Rate at 1 Year After Surgery(From the date of surgery to 1 year after surgery)
- Conversion to Open Surgery Rate(During the index surgery)
- Postoperative Length of Hospital Stay(From surgery to hospital discharge, up to 30 days after surgery)