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A Comparison Laparoscopic With Open Gastric Cancer Surgery for Locally Advanced Gastric Cancer

2016年12月11日 更新者：Moscow Clinical Scientific Center

Prospective Multicenter Study on Laparoscopic Gastric Cancer Surgery Compared With Open Surgery for Locally Advanced Gastric Cancer

Nowadays, the proportion of patients with locally advanced gastric cancer is estimated up to 90 percent of all gastric cancer cases in Russian Federation. Surgical procedure with D2 Lymphadenectomy is the main option for treatment. Conventional open approach is still the current standard for advanced gastric cancer. Laparoscopic procedures for gastric cancer as minimally invasive surgery has gained popularity for the treatment of early gastric cancer in East Asia. Several studies indicated that laparoscopic procedures both total and subtotal gastrectomy with D2 lymphadenectomy is a technically feasible and safe procedure by experienced surgeons in high-volume specialized hospitals. However, lack of solid evidence on the oncologic efficacy.

Starting clinical trials for evaluate safety of oncology laparoscopic subtotal gastrectomy for locally advanced gastric cancer. Aim of this trial is show safety, feasibility and oncologic efficacy of Laparoscopic radical surgical procedures both total and subtotal gastrectomy for treatment gastric cancer.

研究概览

地位

未知

条件

干预/治疗

研究类型

介入性

注册 (预期的)

800

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 乌克兰
      • Kiev、乌克兰
        • 招聘中
        • Lisod clinic
        • 接触：
          • Sergey Baydo, MD, PhD
  • 俄罗斯联邦
      • Lipetsk、俄罗斯联邦
        • 招聘中
        • Lipetsk regional oncological center
        • 接触：
      • Moscow、俄罗斯联邦、111123
        • 招聘中
        • Moscow Clinical Scientific Center
        • 接触：
          • Roman Izrailov, MD, PhD
          • 电话号码：8 (495) 3042908
          • 邮箱：izrailev@mail.ru
        • 接触：
        • 副研究员：
          • Michail Prostov
      • Moscow、俄罗斯联邦
      • Moscow、俄罗斯联邦
        • 招聘中
        • P.Herzen Moscow Oncological Research Institute
        • 接触：
      • Moscow、俄罗斯联邦
        • 招聘中
        • Treatment and Rehabilitation Centre of Health Ministry of Russia
        • 接触：
      • St. Petersburg、俄罗斯联邦
      • St.Petersburg、俄罗斯联邦
        • 招聘中
        • Federal Medical Biology Agence №122 the name of L.Soko
        • 接触：
      • St.Petersburg、俄罗斯联邦
        • 招聘中
        • N. Petrov National Research Institute of Oncology
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 82年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • ECOG 0-1
  • ASA I-III
  • Histologically proven cancer of the stomach cT 2-4a(clinical stage tumor), N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
  • Preoperative examination with no distant metastasis, no significantly enlarged lymph nodes around abdominal main artery, and tumor not a direct violation of the pancreas, spleen and other surrounding organs
  • The gastric tumors are located in the stomach, are macroscopically resectable by subtotal or total gastrectomy with D2 lymph node dissection.
  • Written informed consent

Exclusion Criteria:

  • Clinically apparent distant metastasis
  • Free cancer cells
  • Bulky lymph node metastasis is detected by abdominal CT
  • Previous treatment with radiation therapy for any tumors.
  • Previous surgery for the present disease
  • Pregnancy
  • Psychiatric disease

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Laparoscopic surgery
Traditional open procedure for patient with locally advanced gastric cancer
程序：Open Surgery
Open surgery
有源比较器：Open surgery
Minimum invasive procedure (laparoscopic) for patient with locally advanced gastric cancer
程序：Laparoscopic procedures
Laparoscopic surgery

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
"Major" Surgical Morbidity
大体时间：21 days.
"Major" Surgical morbidity is defined as the complication grade on III-V Clavien-Dindo Classification which occurs with-in postoperative 21 days, extension of hospitalization and re-hospitalization. It is necessary to evaluate the complication and if it occurs during the hospitalization, it is required to record complication name, date of on-set (postoperatively), grade on Clavien-Dindo Classification and treatment for complication.
21 days.

次要结果测量

结果测量
措施说明
大体时间
3-year progression-free survival
大体时间：36 months
In terms of locally advanced gastric cancer, to evaluate the progression-free survival rate in laparoscopic gastrectomy with D2 lymph node dissection at postoperative 3 years compared with open procedures
36 months
3-year overall survival
大体时间：6, 12, 18, 24, 30 and 36 months
In terms of locally advanced gastric cancer, to evaluate the overall survival rate in laparoscopic gastrectomy with D2 lymph node dissection at postoperative 3 years compared with open procedures
6, 12, 18, 24, 30 and 36 months
5-year overall survival rate
大体时间：6, 12, 18, 24, 30, 36, 48 and 60 months
In terms of locally advanced gastric cancer, to evaluate the overall survival rate in laparoscopic gastrectomy with D2 lymph node dissection at postoperative 5 years compared with open procedures
6, 12, 18, 24, 30, 36, 48 and 60 months
Surgical Mortality
大体时间：90 days
It is defined as the death within postoperative 90 days regardless of postoperative reason.
90 days
Peri-operative blood loss
大体时间：1 day
Minimally-invasive surgery is associated with less peri-operative blood loss. Blood loss will be measured in milliliters and average blood loss will be compared to the conventional 'open' group.
1 day
Postoperative recovery index
大体时间：10 days
Time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay are used to assess the postoperative recovery course The amount of abdominal drainage and blood transfusion are also recorded
10 days
Pain scores
大体时间：up to 3 days after surgery
Pain scores based on a visual analog scale the day of surgery and the subsequent 3 days postoperative 1 days, 2 days, 3 days
up to 3 days after surgery
Postoperative quality of life
大体时间：6, 12, 18, 24, 30 and 36 months
Both the European Organization for Research and Treatment of Cancer (EORTC) C30 and STO22 are analyzed with quality of life
6, 12, 18, 24, 30 and 36 months
long-term surgical morbidity
大体时间：21days - 36 months after surgery
Surgical morbidity is defined as the events which occurs with-in postoperative 21 days - 36 months after surgery. It is necessary to evaluate the complication, it is required to record complication name, date of on-set. Long complications are included: hernia, bleeding, bowel obstruction etc.
21days - 36 months after surgery
Extent of lymph node dissection
大体时间：2 weeks
The extent of lymph node dissection in treatment of gastric cancer is considered a prognostic marker for postoperative survival and disease-free survival. Before implementation of a new surgical technique, it is imperative that this technique is non-inferior with regard to the extent of lymph node dissection. Measures will include the number of resected lymph nodes and the number of resected lymph node stations.
2 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Moscow Clinical Scientific Center

调查人员

  • 学习椅：Michail Byachov, MD, PhD、Moscow Clinical Scientific Center
  • 学习椅：Roman Izrailov, MD, PhD、Moscow Clinical Scientific Center
  • 首席研究员：Boris Pomortsev, MD、Moscow Clinical Scientific Center
  • 首席研究员：Pavel Kononets, MD, PhD、Moscow Oncological Hospital 62
  • 首席研究员：Andrey Ryabov, MD, PhD、P.Herzen Moscow Oncological Research Institute
  • 首席研究员：Vladimir Lyadov, MD, PhD、Treatment and Rehabilitation Centre of Health Ministry of Russia
  • 首席研究员：Alexey Karachun, MD, PhD、N. Petrov National Research Institute of Oncology
  • 首席研究员：Victor Kashchenko, MD, PhD、Federal Medical Biology Agence №122 the name of L.Sokolov
  • 首席研究员：Andrey Pavlenko, MD, PhD、Leningradsky oncological center
  • 首席研究员：Michail Lando, MD, PhD、Lipetsk regional oncological center
  • 首席研究员：Sergey Baydo, MD, PhD、Lisod clinic Kiev
  • 研究主任：Igor Khatkov, MD, PhD、Moscow Clinical Scientific Center
  • 首席研究员：Michail Prostov、Moscow Clinical Scientific Center
  • 首席研究员：Kirill Schostka, MD, PhD、Leningradsky oncological center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年4月1日

初级完成 (预期的)

2018年4月1日

研究完成 (预期的)

2022年4月1日

研究注册日期

首次提交

2016年4月10日

首先提交符合 QC 标准的

2016年4月19日

首次发布 (估计)

2016年4月22日

研究记录更新

最后更新发布 (估计)

2016年12月13日

上次提交的符合 QC 标准的更新

2016年12月11日

最后验证

2016年12月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • MKNC 01/2016

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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条件

罕见疾病

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