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临床试验/NCT03792932
NCT03792932Unknown不适用

A Multicenter Prospective RCT Study of Laparoscopic Versus Open Distal Pancreatectomy in Patients With Pancreatic Cancer at the Body and Tail

Fudan University11 个研究点 分布在 1 个国家目标入组 306 人开始时间: 2019年2月2日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xian-Jun Yu

Chair of Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Fudan University

研究点 (11)

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