Radical Antegrade Modular Pancreatosplenectomy Versus Standard Retrograde Pancreatosplenectomy on the Survival and Prognosis for Resectable Body and Tail Pancreatic Ductal Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Two arms RCT is design, patients with pancreatic body or tail adenocarcinoma will be randomly assigned to the Radical Antegrade Modular Pancreaticosplenectomy (RAMPS) group or Standard Retrograde Pancreatosplenectomy (SRPS) group. The primary objective is to evaluate the effect of RAMPS on the overall survival of patients with resectable body and tail pancreatic ductal adenocarcinoma. And the secondary objective is to evaluate the disease-free survival, R0 resection rate, number of retrieved lymph nodes and perioperative outcomes like postoperative complication rate, severe complications, mortality and functional recovery time between the experimental group and control group.
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 (Participant)
盲法说明
The participant will not know which group they are assigned to, but the surgeons know which group they were randomly assigned to.
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
- •Age 18-80 years old;
- •Resectable pancreatic body and tail ductal adenocarcinoma with both preoperative and intraoperative evaluation(refer to NCCN guideline 2018 of Pancreatic Cancer);
- •ECOG Performance Status 0-1;
- •Adenocarcinoma of pancreatic body and tail duct, without distant metastasis and ascites;
- •The estimated survival time is ≥ 3 months;
- •Follow-up in time and obey the research requirements;
- •Be voluntary to this clinical trial and can sign the informed consent;
- •Normal hematological index (Leukocyte, platelet, liver function, renal function, DIC, electrolyte index, Hb >10g/dL).
排除标准
- •The patients with distant metastasis according to preoperative tumor staging;
- •Patients with recurrent pancreatic ductal adenocarcinoma;
- •The artery or vein is involved and could not be resected or reconstructed(according to preoperative evaluation or intraoperative evaluation after exploration);
- •Patients with cardiopulmonary disfunction and cannot tolerate operation;
- •The patients accepted neoadjuvant chemotherapy and radiotherapy before operation;
- •Patients with other malignancies or hematopathy
- •Before the operation, the total bilirubin was more than 250 μmol/L without preoperative biliary drainage or after biliary drainage, the total bilirubin was still more than 250 μmol/L;
- •Pregnancy diagnosed, planned pregnancy and lactating female patients
- •Refusal to sign consent.
- •Intraoperative exclusion include:Tumor metastasis; not pancreatic primary disease; unresectable pancreatic body/tail adenocarcinoma
- •Postoperative exclusion include: not pancreatic ductal adenocarcinoma according to pathological examination.
- •Withdrawal of informed consent;
- •Willingness to withdraw from the study.
研究组 & 干预措施
RAMPS group
Radical antegrade modular pancreatosplenectomy (RAMPS) includes the following aspects. Firstly, the surgical approach is "antegrade", which means from the right to the left, the pancreatic neck will be transected at first and the spleen will be seperated at last. Secondly, lymph nodes dissection includes not only the regional lymph nodes(No.10,11,18 lymph nodes), but also N1 station lymph nodes (N1: 6, 8a, 8p, 12a2/b2/p2, 13a/b, 14b/c/d, 14v, 17a/b), No.7, 9 lymph nodes, the lymph nodes anterior and left of superior mesenteric artery, as well as the peripheral nerve of celiac trunk. Thirdly, the transection platform is in the pancreatic neck, which is mandatory. At last, left prerenal fascia will be resected. When the tumor abuts or infiltrates the left adrenal gland, left adrenalectomy will be performed, which is also called "posterior approach RAMPS". While in normal cases, left adrenal gland will be preserved.
干预措施: Radical antegrade modular pancreatosplenectomy (Procedure)
SRPS group
Standard retrograde pancreatosplenectomy(SRPS) includes several key points. Firstly, the surgical approach is "retrograde", which means from the left to the right, spleen will be seperated at first and the pancreas will be transected later on. Secondly, only the regional lymph nodes will be dissected, which include No.10, No.11, No.18 lymph nodes, and No.9 lymph nodes should be dissected only when the lesion is in pancreatic neck. Thirdly, the transection platform is in the left side of the lesion, but transection at pancreatic neck is not mandatory. At last, the surgical plane is anterior to the left renal fascia, prerenal fascia will be preserved.
干预措施: Standard retrograde pancreatosplenectomy (Procedure)
结局指标
主要结局
Overall survival
时间窗: 21 months
Overall survival was defined as the time from surgery to either death or last follow-up. Patients will be observed or contacted every 2 months in the first 2 years after surgery and then every 3 months thereafter. Overall survival measurement will be based on patient's survival status and what is the date of death if the patient is not alive.
次要结局
- Disease free survival(11 months)
- retrieved lymph nodes(1 month)
- R0 resection rate(1 month)
研究者
Yuanchi Weng
Attending Physician
Ruijin Hospital