Mesenteric Approach vs. Conventional Approach for Pancreatic Cancer During Pancreaticoduodenectomy (MAPLE-PD Trial)
试验速览
- 阶段
- 3 期
- 入组人数
- 354
- 试验地点
- 16
- 主要终点
- overall survival
研究概览
简要总结
The aim of this study is to evaluate the advantage of mesenteric approach during pancreaticoduodenectomy (PD) for pancreatic ductal adenocarcinoma (PDAC). The design of this study is multicenter randomized clinical trial, comparing oncological and surgical outcomes between mesenteric approach and conventional approach during PD for PDAC.
详细描述
Mesenteric approach starts from dissection of lymph nodes around the superior mesenteric artery (SMA) and finally performs Kocher's maneuver during PD. The aims of this approach are 1) decrease of intraoperative blood loss volume, 2) increase of R0 rate, and 3) prevention of squeezing cancer cells out into the vessels. However, there have been no evidence of the efficacy of this procedure. Therefore, the aim of this study is to evaluate the efficacy of mesenteric approach during PD for PDAC, by multicenter randomized clinical trial comparing oncological and surgical outcomes between mesenteric approach and conventional approach during PD for PDAC.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who are scheduled to undergo pancreaticoduodenectomy for resectable or borderline resectable (only portal vein invasion) pancreatic ductal adenocarcinoma.
- •Patients whose Eastern Cooperative Oncology Group performance status are 0 or
- •Patients who are 20 years or older.
- •Patients who have adequate organ function.
- •Patients who understand sufficiently the study to provide written informed consent
排除标准
- •Patients who have severe ischemic cardiovascular disease
- •Patients who have liver cirrhosis or active hepatitis
- •Patients who need oxygen due to interstitial pneumonia or lung fibrosis
- •Patients who receive dialysis due to chronic renal failure
- •Patients who need surrounding organ resection
- •Patients who need artery reconstruction
- •Patients who are diagnosed as positive para-aortic lymph node metastases based on preoperative imaging
- •Patients who have active multiple cancer that is thought to influence the occurrence of adverse events
- •Patients who take steroid for the long period that is thought to influence the occurrence of adverse events
- •Patients who undergo laparoscopic or laparoscopy-assisted pancreaticoduodenectomy
- •Patients who cannot understand ths study due to psychotic disease or psychological symptoms
- •Patients whose preoperative biopsy tissues are diagnosed as other pathological findings than pancreatic ductal adenocarcinoma
- •Patients who underwent gastrectomy or colon/ rectum resection previously
- •Patients who have severe drug allergy to iodine and gadolinium
研究组 & 干预措施
mesenteric approach
mesenteric approach starts from lymph node dissection around the superior mesenteric artery and performs Kocher's maneuver finally during pancreaticoduodenectomy.
干预措施: pancreaticoduodenectomy (Procedure)
conventional approach
Conventional approach starts from Kocher's maneuver and finally performs lymph node dissection around the superior mesenteric artery during pancreaticoduodenectomy.
干预措施: pancreaticoduodenectomy (Procedure)
结局指标
主要结局
overall survival
时间窗: up to 48 months
survival from surgery to death
次要结局
- grade B/C pancreatic fistula rate(up to 3 months)
- operative time(up to 24 months)
- time for resection(up to 3 months)
- intraoperative blood loss(up to 3 months)
- blood transfusion volume(up to 3 months)
- rate of delayed gastric emptying(up to 3 months)
- abdominal hemorrhage rate(up to 3 months)
- all morbidity rate(up to 3 months)
- mortality rate(up to 3 months)
- diarrhea rate(up to 24 months)
- R0 rate(up to 3 months)
- R1 rate(up to 3 months)
- the closest length between surgical margin and cancer cell(up to 3 months)
- number of harvested lymph nodes(up to 3 months)
- number of metastatic lymph nodes(up to 3 months)
- lymph node ratio(up to 3 months)
- recurrence free survival(up to 24 months)
- site of initial recurrence(up to 24 months)
研究者
Hiroki Yamaue
Professor
Wakayama Medical University