跳至主要内容
临床试验/NCT03273920
NCT03273920Unknown不适用

Robotic Versus Laparoscopic Distal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer: a Multicenter Randomized Controlled Trial

Southwest Hospital, China14 个研究点 分布在 1 个国家目标入组 1,110 人开始时间: 2017年9月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
1,110
试验地点
14
主要终点
3-year relapse-free survival

研究概览

简要总结

This study is an investigator-initiated, randomized, controlled, parallel group, and non-inferiority trial comparing robot-assisted gastrectomy with D2 nodal dissection for locally advanced gastric cancer patients with laparoscopic procedure.

详细描述

Since the first case of laparoscopy-assisted distal gastrectomy was reported in 1994, the number of patients undergoing the laparoscopic procedure has gradually increased. The latest Japanese gastric cancer treatment guideline recommends laparoscopic gastrectomy (LG) as an optional treatment for cStage I gastric cancer (GC). Based on the experience of early GC, most experienced surgeons have applied the laparoscopic procedure in patients with locally advanced gastric cancer (AGC). According to the results of large-scaled retrospective studies and ongoing randomized controlled trials (RCTs), LG treating AGC can gain better short-term outcomes and comparable long-term oncologic results.

To minimize the limitations of laparoscopic surgery, robot systems have been introduced to treat GC providing technical advantages. Though the feasibility and safety of robotic gastrectomy (RG) have been well accepted, the benefits of RG remain controversial. A recent meta-analysis including eleven studies of 3503 patients demonstrated that RG indicated potentially favorable outcomes in terms of blood loss compared with LG. Furthermore, it has been confirmed that robotic system could provide an advantage over LG in the dissection of the N2 area lymph nodes, especially around the splenic artery area. Our previous study demonstrated that the RG had less intraoperative blood loss and more lymph nodes dissection compared with the laparoscopic procedure. However, the only prospective study reported that RG is not superior to LG in terms of perioperative surgical outcomes. Nevertheless, the following subgroup analysis found that patients with GC undergoing D2 lymph node dissection can benefit from less blood loss when a robotic surgery system is used. Take together, RG with D2 nodal dissection may be superior laparoscopic surgery in terms of blood loss and retrieved lymph nodes. However, lack of high-level evidence-based medical researches, we can't drew a conclusion that patients with AGC may benefit from RG with D2 nodal dissection.

With regard to a new surgical approach, oncologic safety has attracted more attention. Although some retrospective studies have demonstrated that RG with lymphadenectomy for GC had non-inferior oncologic outcome relative to LG, there is no prospective RCT to evaluate the long-term outcomes of RG. Therefore, the Chinese Robotic Gastrointestinal Surgery Study (CRASS) Group launched a multicenter prospective RCT to verify the short-term and long-term outcomes of RG in AGC. The primary objective of this study is to assess whether robot-assisted distal gastrectomy is comparable to laparoscopic approach in terms of long-term oncologic outcomes without compromising relapse-free survival. The secondary research objectives are to compare robotic and laparoscopic approach in terms of morbidity, mortality, quality of life, cost-effectiveness, and overall survival.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pathologically proven gastric adenocarcinoma.
  • Tumor located in the lower third of the stomach, and is possible to be curatively resected by subtotal gastrectomy.
  • Preoperative stage of cT2-4aN0-3M0 according to American Joint Committee on Cancer/Union for International Cancer Control 8th edition
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • American Society of Anesthesiology (ASA) score of class I to III
  • Patients who freely give informed consent to participate in the clinical study

排除标准

  • Previous upper abdominal surgery (except laparoscopic cholecystectomy)
  • Previous gastric resection (gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection)
  • Gastric cancer-related complications (complete obstruction or perforation)
  • Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging
  • Previous neoadjuvant chemotherapy or radiotherapy for gastric cancer
  • Patients diagnosed with other malignancy within 5 years
  • Severe mental disorder
  • Unstable angina or myocardial infarction within the past 6 months
  • Cerebrovascular accident within the past 6 months
  • Severe respiratory disease (FEV1< 50%)
  • Continuous systemic steroid therapy within 1 month before the study
  • Pregnant or breast-feeding women

研究组 & 干预措施

Robotic gastrectomy

Experimental

Robotic distal gastrectomy with D2 nodal dissection

干预措施: Robotic distal gastrectomy with D2 nodal dissection (Procedure)

Laparoscopic gastrectomy

Active Comparator

Laparoscopic distal gastrectomy with D2 nodal dissection

干预措施: Laparoscopic distal gastrectomy with D2 nodal dissection (Procedure)

结局指标

主要结局

3-year relapse-free survival

时间窗: 3 years

Relapse-free survival is defined as days from surgery to recurrence or death from any cause, and it is censored at the latest day when the patient is alive without any evidence of recurrence.

次要结局

  • Mortality(30 days)
  • 3-year overall survival(3 years)
  • Postoperative recovery course(15 days)
  • Morbidity(30 days)
  • 3-year recurrence pattern(3 years)
  • Immune response(7 days)
  • Inflammatory response(7 days)

研究者

发起方
Southwest Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yan Shi

Deputy director

Southwest Hospital, China

研究点 (14)

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