Peri-operative and Oncological Outcomes of Robotic Vs Laparoscopic Pancreatoduodenectomy: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
研究概览
简要总结
Pancreatoduodenectomy (PD) is the standard surgical treatment for malignant and benign diseases of the pancreatic head, duodenum, ampulla of Vater, and distal common bile duct. Minimally invasive approaches, such as Laparoscopic PD (LPD) and Robotic PD (RPD), are increasingly performed, but there is limited high-quality evidence directly comparing their safety and oncological efficacy.
This prospective study aims to compare perioperative outcomes and short-term oncological results between LPD and RPD. The primary objective is to assess whether RPD reduces major postoperative morbidity (Clavien–Dindo grade more than or equal to IIIa) compared to LPD. Secondary objectives include evaluation of operative parameters, postoperative recovery, complication profile, margin status, lymph-node yield, and 90 day mortality. Findings from this trial will help define the optimal minimally invasive approach for PD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Age above 18 years b) Patients undergoing minimally invasive PD for clinically indicated malignant or premalignant lesions in the pancreatic and periampullary region c) Resectable lesion less than 4 cm in size without vascular invasion d) ECOG performance status 0 or 1 e) Absence of prohibitive cardiopulmonary comorbidities that preclude prolonged pneumoperitoneum f) Absence of uncorrected coagulopathy, chronic liver disease, or chronic renal disease.
排除标准
- •a) Pregnancy b) Previous history of major upper abdominal surgery c) Open or Hybrid Pancreatoduodenectomy d) Emergency Pancreatoduodenectomy e) Requirement for multi-visceral resection f) Borderline or locally advanced Pancreatic cancer.
研究者
Vaibhav Kumar Varshney
All India Institute of Medical Sciences, Jodhpur