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临床试验/NCT04384757
NCT04384757进行中(未招募)不适用

Comparison of Laparoscopic Versus Open Distal Gastrectomy for T4a Gastric Cancer: a Prospective Randomized Control Trial

University Medical Center Ho Chi Minh City (UMC)2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2020年7月29日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
240
试验地点
2
主要终点
3 year overall survival by Kaplan Mayer

研究概览

简要总结

There are more than 75% of patients with gastric cancer who are diagnosed in advanced stage in Vietnam, most of cases in T4a. The purpose of this study is to compare the technical feasibility, early and long term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in T4A stage

详细描述

Gastric cancer poses a significant public health problem. It is one of the most common cancers in Vietnam . Despite recent advances in multimodality treatment and targeted therapy, surgery remains the first option of treament for this disease. For resectable gastric cancer, complete removal of macroscopic and microscopic lesions and/or combined resections and also regional or extended lymphadenectomy should represent in the world now. Since laparoscopic gastrectomy for early gastric cancer (EGC) was firstly reported in 1994 , this technique has become standard for treatment of EGC due to the many advantages of mininally invasive surgery and also in oncologic outcomes.

Laparoscopic gastrectomy for advanced gastric cancer AGC was first applied by Uyama in 2000, and then, many surgeons have used it for treatment of AGC, especially in Japan, Korea and China. However, the real role of laparoscop for treament of (AGC) is still controversial in term of technical feasibility, safety and oncologic aspect.

Paragastric inflammatory strands may occur in T4a tumor so that laparoscopic technique is difficult to radically perform. Peritoneal seeding of malignant cells, intra- and postoperative complications, trocarts metastasis may risk during procedures. Despite, some studies have demonstrated the safety and the short-term benefits of LG for T4a gastric cancer, the number of these studies and sample sizes have been still inadequate to give good evidence for applying it. and long-term oncologic outcomes

There are more than 75% of patients with gastric cancer who are diagnosed in advanced stage in Vietnam, most of cases in T4a. The purpose of this study is to compare the technical feasibility, early and long term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in T4A stage.

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)

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

入选标准

  • Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma
  • Age: 18 - 80 year old
  • Tumor located at the middle or lower third of the stomach
  • Preoperative cancer stage (CT scan stage): cT4aN0M0, cT4aN1M0, cT4aN2M0, cT4aN3M0
  • ASA score: ≤ 3
  • Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available)

排除标准

  • Concurrent cancer or patient who was treated due to other cancer before the patient was diagnosed gastric cancer
  • Had another treatment methods, such as chemotherapy, immunotherapy, or radiotherapy
  • Pregnant patient
  • Combined resection
  • Total gastrectomy

结局指标

主要结局

3 year overall survival by Kaplan Mayer

时间窗: 3 year after surgery

The percentage of people in this study who are alive three years after surgery.

3 year relapse-free survival by Kaplan Mayer

时间窗: 3 year after surgery

The percentage of people in this study who are alive without recurrence three years after surgery.

次要结局

  • operative mortality(30 days after surgery)
  • operative time(intraoperative)
  • hospital stay(30 days after surgery)
  • Resected lymph nodes(intraoperative)
  • operative morbidity(30 days after surgery)

研究者

发起方
University Medical Center Ho Chi Minh City (UMC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

VoDuy Long

Deputy Head of GI Surgery Department

University Medical Center Ho Chi Minh City (UMC)

研究点 (2)

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