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临床试验/NCT02287168
NCT02287168已完成早期 1 期

Effect of Peritoneal Lavage on Surgery-induced Positive Peritoneal Cytology in Gastric Cancer Patients

Bezmialem Vakif University4 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
34
试验地点
4
主要终点
elimination

研究概览

简要总结

Surgical manipulation and handling of a tumor may cause dissemination of cancer cells through peritoneal cavity after curative gastrectomy. Intra operative peritoneal lavage may have preventive effect on positive peritoneal cytology occurred during gastrectomy in patients with gastric cancer.

详细描述

Peritoneal dissemination of gastric adenocarcinoma cells is the most frequent cause of death in patients with gastric cancer. Spreading of these cells occur by three routes: direct seeding via infiltration through gastric wall, via blood vessels and via perigastric lymphatic channels disturbed during lymph node dissection. Conversion of negative preoperative peritoneal cytology to positive cytology after curative gastrectomy has been shown by previous studies.

Although extensive intra-operative peritoneal lavage (1 L of physiologic saline 10 times) has been shown to be an effective method to eliminate cancer cell dissemination during surgery, to cause significant improvement in survival after gastrectomy, widespread use of this approach has not existed most probably due to its time consuming technical difficulty. Therefore,intra-operative peritoneal lavage (1 L of physiologic saline 3 times) may be used more frequently during gastric surgery.If it is possible to show effectivity of intra-operative peritoneal lavage using a total of 3 L physiologic saline to eliminate cancer cell dissemination occurred before or after gastric surgery, use of this approach may gain acceptance to decrease risk of peritoneal metastasis.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Endoscopically proven gastric adenocarcinoma
  • Standard gastrectomy and a D2 lymph node dissection;
  • Desire to attend the study protocol

排除标准

  • Metastatic or overt peritoneal disseminated cancer
  • Undesired reaction to attend the study protocol

结局指标

主要结局

elimination

时间窗: at the operation

rate of conversion of positive cytology results to negative cytology by peritoneal lavage during the surgery

次要结局

  • dissemination(at the operation)

研究者

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

Mustafa Hasbahceci

MD, general surgeon

Bezmialem Vakif University

研究点 (4)

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