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临床试验/NCT05013775
NCT05013775已完成不适用

The Diagnostic Value of Staging Laparoscopy and Computed Tomography Response Assessment in Patients With Gastric Adenocarcinoma

Sander van Hootegem1 个研究点 分布在 1 个国家目标入组 697 人开始时间: 2019年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
697
试验地点
1
主要终点
Change in treatment

研究概览

简要总结

SUMMARY

Rationale: Diagnostic laparoscopy (DL) and response assessment after neoadjuvant chemotherapy with computed tomography (CT) are two diagnostic modalities used to assess metastatic spread in gastric cancer patients. It is still unclear in what proportion of patients clinically relevant metastases or other significant findings (e.g. contra-indications of surgery) are detected that impact on the treatment.

Objective: To determine the clinical value of diagnostic laparoscopy and computed tomography response assessment after neoadjuvant chemotherapy in patients with gastric and esophagogastric junction adenocarcinoma.

Study design: Multicentre retrospective cohort study.

Study population: All Patients with gastric and gastro-oesophageal adenocarcinoma who underwent clinical staging and were discussed at multidisciplinary team meetings (MDT) between January 2016 and December 2018.

Intervention (if applicable): Not applicable.

Main study parameters/endpoints: The main study parameter is the proportion (%) of patients who do not proceed with treatment as planned after a DL and CT response assessment (i.e. the proportion of patients in which metastasized disease or other contra-indications for surgery is found).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Since this is an observational study, no burden or risks are associated with participation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with histologically proven gastric and esophagogastric junction adenocarcinoma.
  • •Patients who have had (either) DLS and/or CT response assessment (after chemotherapy).
  • •Discussed at MDT from January 2016 - December 2018
  • •≥18 years

排除标准

  • •Patients with esophagogastric junction adenocarcinoma with the tumour bulk located in the oesophagus that receive neoadjuvant chemoradiation;
  • •Patients with recurrent/residual disease after earlier treatment of gastric cancer.

结局指标

主要结局

Change in treatment

时间窗: 1 month (on average)

Proportion of patients in which the diagnostic test led to change in treatment/management

次要结局

未报告次要终点

研究者

发起方
Sander van Hootegem
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sander van Hootegem

Investigator

Erasmus Medical Center

研究点 (1)

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