Extended Pancreatic Neck Transection Versus Conventional Pancreatic Neck Transection During Laparoscopic Pancreaticoduodenectomy( LPDEXCEPT): a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- the incidence of clinically relevant pancreatic fistula
研究概览
简要总结
The investigators conduct the clinical randomized controlled trial to evaluate the superiority of extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy (LPD). The participants in the study group obtain extended pancreatic neck transection during LPD, while participants in the control group conventional pancreatic neck transection. The purposes of this study include: 1.Primary objective: To compare the incidence of clinically relevant pancreatic fistula (grades B-C according International Study Group on Pancreatic Surgery) between the study group and the control group. 2.Secondary objective: To compare the incidence of postoperative morbidity (Clavien-Dindo score ≥3）between the two groups. To compare the location of pancreatic duct and the surgical performance of pancreaticojejunostomy between the two groups.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with benign or resectable malignant tumors of the lower common bile duct, Vater ampulla, head or uncinate process of the pancreas.
- •18 years old < age < 80 years old, no gender limit.
- •Patient is expected survival beyond 3 months.
- •No pregnancy or pregnancy plan within 3 months after surgery.
- •Nutrition risk score <3 according to the Nutritional Risk Screening for Inpatients 2002 (NRS2002) standard score.
- •No contraindication to surgery for anesthetic evaluation.
- •The subjects voluntarily joined the study and signed an informed consent form, with good compliance and cooperation with follow-up.
排除标准
- •Patients with borderline resectable and unresectable malignancies.
- •Patients undergoing neoadjuvant chemotherapy or radiotherapy.
- •Patients with tumors exceeding the level of the gastroduodenal artery as measured by preoperative radiography.
- •Intraoperative exploration reveals tumor adhesions with portal vein-superior mesenteric vein, requiring revascularization and reconstruction.
- •Operation transfers to open.
- •Operation transfers to other procedure.
- •The main pancreatic duct can not be found intraoperatively, the duct-to-mucosa pancreaticojejunostomy can not be operated.
结局指标
主要结局
the incidence of clinically relevant pancreatic fistula
时间窗: 3 months postoperatively
the incidence of the clinically relevant pancreatic fistula according the International Study Group of Pancreatic Surgery's definition and grading
次要结局
- surgical performance of pancreaticojejunostomy(intraoperatively)
- postoperative mortality(3 months postoperatively)
- location of the pancreatic duct in the pancreatic transverse section(intraoperatively)
- postoperative morbidity(3 months postoperatively)
研究者
Xinrui Zhu，MD
attending doctor
West China Hospital