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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

BMC Cancer 1/2018

Staging laparoscopy for locally advanced gastric cancer in Chinese patients: a multicenter prospective registry study

Zeitschrift:
BMC Cancer > Ausgabe 1/2018
Autoren:
Ziyu Li, Zhemin Li, Lianhai Zhang, Qian Liu, Zhenjun Wang, Zhongtao Zhang, Gang Xiao, Wei Fu, Xin Wang, Yingjiang Ye, Jianchun Yu, Fei Li, Lin Chen, Shibin Wang, Jiafu Ji

Abstract

Background

Staging laparoscopy(SL) is a recommended technique for the staging of Gastric Cancer(GC) and provides the indication for a radical surgery. Considering the medical practice in China, the standardized and regular usage of SL is yet to be spread. However, existing guidelines vary and make an ambiguity of indication for SL. Besides, the specific indication for Chinese patients remains a niche. This study aims to the essential, missing information of Chinese patients and tries to normalize the indication of LS in medical practice in China.

Methods

The study is a prospective, multicenter cohort study being conducted in China with a total of 450 patients, all diagnosed with locally advanced gastric cancer (cT2-4 N0-3 M0, no evidence of intra-abdominal dissemination) through Computed Tomography(CT) and/or Endoscopic Ultrasonography(EUS). Peritoneal lavage is regularly performed during the SL. Multivariate Cox regression model and receiver-operator characteristic(ROC) analysis will be used to analyze the significant risk factors of intra-abdominal metastasis(including peritoneal dissemination and a positive cytological result).

Discussion

This confirmatory study will provide us with the specific positive rate of intraabdominal metastasis of GC in China, compared with empirical evidence of 20%. We expect this trial will contribute to our discovery of the specific risk factors of intra-abdominal metastasis of Chinese patients and to the stimulating and performing of minimally invasive surgical procedures.

Trial registration

ClinicalTrials.​gov: registration number NCT02172690.
Literatur
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