A Multicenter Prospective RCT Study of Laparoscopic Versus Open Distal Pancreatectomy in Patients With Pancreatic Cancer at the Body and Tail
试验速览
- 阶段
- 不适用
- 入组人数
- 306
- 试验地点
- 11
- 主要终点
- Recurrence Free Survival
研究概览
简要总结
Open distal pancreatectomy (ODP) has been commonly employed for the treatment of a variety of cancers in body and tail of pancreas. Although many general surgical procedures have been increasingly performed laparoscopically or with laparoscopic assistance, until the current decade, laparoscopic pancreatic surgery had not been performed for its complicated anatomy. But laparoscopic distal pancreatectomy (LDP) has been widely accepted as a standard treatment for body and tail pancreatic cancer because there is no anastomosis in it, and LDP has gradually become the first choice for these cancers in clinical work. Although there are several studies about the comparison between LDP and ODP, most are retrospective and there is no agreement in surgical margin, lymph node numbers and prognosis to identify the oncological differences between the two surgical approaches. The investigators' pilot study showed that patients with body and tail pancreatic cancer underwent LDP had a better prognosis compared with the ones undergoing ODP, with no statistics differences in postoperative complications and mortality. This perspective RCT study is performed to confirm whether LDP would improve the prognosis for patients with body and tail pancreatic cancer compared with ODP.
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
- 19 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 19 years and ≤ 80 years, no gender limitation
- •Resectable body and tail pancreatic cancer (refer to NCCN 2018)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Tumor locates at the body and tail of the pancreas without distant metastasis
- •No celiac trunk and superior mesenteric artery invasion
- •No operation contraindication, fit for laparoscopic surgery
- •The expected survival after surgery ≥ 3 months
- •Patients who are willing and able to comply with the study procedure
- •Signed informed content obtained prior to treatment
排除标准
- •Locally advanced unresectable body and tail pancreatic cancer
- •Multi-organ and vascular resection needed
- •Patients undergoing total pancreatectomy
- •Benign tumor at the body and tail of the pancreas or pancreatic cancer at the head of the pancreas
- •Distant metastasis or ascites detected by imaging
- •Severe important organ function impairment (heart, liver, kidney)
- •Patients who are with other primary malignancy or haematological disorders
- •Pregnant or nursing women
- •Patients who have received chemotherapy, radiotherapy and interventional therapy before the pancreatectomy
- •Patients who have participated in other clinical trials for pancreatic cancer treatment within 3 months
结局指标
主要结局
Recurrence Free Survival
时间窗: 2 years
RFS
次要结局
- R0 resection rate(2 years)
- Overall Survival(2 years)
- Detected lymph node number(2 years)
研究者
Xian-Jun Yu
Chair of Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Fudan University
