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临床试验/NCT03117283
NCT03117283Unknown2 期

Laparoscopic Total Gastrectomy With Bursectomy in a Left Outside Bursa Omentalis Approach Versus Laparoscopic Total Gastrectomy Without Bursectomy for Advanced Posterior Gastric Wall Cancer: a Randomized Controlled Study

Guangdong Provincial Hospital of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2017年3月28日最近更新:
适应症

试验速览

阶段
2 期
发起方
入组人数
56
试验地点
1
主要终点
Early morbidity

研究概览

简要总结

Bursectomy is widely performed in open surgery for advanced gastric cancer in East Asia. However laparoscopic D2 radical total gastrectomy with complete bursectomy is difficult and rare performed. Herein, we conduct a single-centre randomized controlled trial to explore the safety and feasibility of totally laparoscopic D2 radical total gastrectomy using a left outside bursa omentalis approach for achieving complete bursectomy.

详细描述

Although, the clinical value of bursectomy in addition to D2 lymphadenectomy in radical gastrectomy for curable gastric cancer is controversial. Data analysis of the nationwide registry of gastric cancer in Japanese revealed that 10.7% of patients with subserosal and serosal positive cancer developed peritoneal recurrence after radical gastrectomy. Some trials, although, indicated a biologically reasonable but statistically non-significant advantage to bursectomy. But for patients with posterior gastric wall trans-serosal disease, such micrometastases can constitute the seeds of later recurrence. The non-bursectomy showed worse overall survival. Early removal of micrometastases and cancer cells deposited might prove beneficial and a possible therapeutic effect. In any case, the authors reasonably concluded that bursectomy should not be abandoned at this time. The hypothesis that it might actually enhance survival should be entertained. In the past decades, Japanese, Korea, Chinese and even Turkey, surgeons have continued to performed bursectomy and lymph nodes dissection as the conventional open procedures for advanced gastric cancer. Lymph nodes dissection and bursectomy is routinely regarded as a standard surgical procedure during radical open gastrectomy for tumors penetrating the serosa of the posterior gastric wall. Complete bursectomy and lymphadenectomy in open radical gastrectomy may represents a formidable challenge to the best of surgeons and its influences on operative morbidity and mortality, but it can be also safely performed in high volume experience centers or by experienced surgeons with mortality rate of <1% and morbidity rates around 14%.

Generally speaking, bursectomy is incomplete without total gastrectomy. The concept of bursectomy mentioned above is always almost confined to removal of the local anterior membrane of the transverse mesocolon and pancreatic capsule and to open radical gastrectomy. With the generalization and development of laparoscopic technology, laparoscopic surgery for advanced gastric cancer as clinical study has extensively performed in Asia.The investigators take the lead in carrying out laparoscopic bursectomy and D2 radical gastrectomy by. Herein, the investigators conduct a single-centre randomized controlled trial to explore the safety and feasibility of totally laparoscopic D2 radical total gastrectomy using a left outside bursa omentalis approach for achieving complete bursectomy.

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

入选标准

  • Primary gastric adenocarcinoma diagnosed pathologically by endoscopic biopsy
  • Tumor located in the posterior wall of upper and middle third stomach estimated by endoscopy and CT scan
  • Informed consent
  • Eastern Cooperative Oncology Group (ECOG): 0 ot 1
  • American Society of Anesthesiologists (ASA) score: Ⅰto Ⅲ

排除标准

  • Pregnancy or female in suckling period
  • Contraindication to general anesthesia (severe cardiac and/or pulmonary disease)
  • Severe mental disease
  • Emergency operation due to complication (bleeding, perforation or obstruction) caused by primary tumor

结局指标

主要结局

Early morbidity

时间窗: 30 days

The early morbidity is defined as the adverse event observed during peri-operative time.

次要结局

  • First flatus(30 days)
  • Estimated blood loss(Intraoperative)
  • Lymph node(14 days)
  • 5-year survival(5 years)
  • Operative time(Intraoperative)
  • First ambulation(30 days)
  • First liquid diet(30 days)
  • 3-year survival(3 years)
  • Hospital stay(30 days)

研究者

发起方
Guangdong Provincial Hospital of Traditional Chinese Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wei Wang

Wei Wang M.D., PhD.

Guangdong Provincial Hospital of Traditional Chinese Medicine

研究点 (1)

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