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临床试验/NCT05671393
NCT05671393已完成不适用

A Multi-institution Real-world Study of the Optimal Surveillance Frequency for Patients With Gastric Neuroendocrine Carcinoma

Fujian Medical University1 个研究点 分布在 1 个国家目标入组 801 人开始时间: 2008年1月1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
801
试验地点
1
主要终点
recurrence rate

研究概览

简要总结

Due to lacking of evidence on surveillance for gastric neuroendocrine carcinoma (G-NEC), this study aimed to determine the optimal postsurgical surveillance strategy for G-NEC patients and compare its cost-effectiveness with traditional surveillance strategies.

详细描述

The development of existing follow-up strategies is mainly based on experts' consensus and researches on recurrence patterns due to the lack of direct evidence and unified standards. On the one hand, it is unreasonable to carry out the same postoperative surveillance for all G-NEC patients. In addition to the early detection of recurrence, the optimal follow-up strategy should also balance cost and effectiveness. There were no criteria for the arrangement of follow-up in different guidelines, and the optimal postoperative follow-up strategy for patients with G-NEC remains unclear. Patients with G-NEC from 21 centers in China were included. Cost-effectiveness were assessed by Markov model.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • This multicentre retrospective study included patients with gastric neuroendocrine neoplasms who underwent surgery in 21 centres of the Study Group for Gastric Neuroendocrine Tumours in China from January 2008 to December
  • Radical surgery included a D2 lymphadenectomy consistent with the Japanese gastric cancer treatment guidelines.

排除标准

  • Patients with tumours of unknown pathology (only neuroendocrine neoplasms recorded without detailed information); patients with gastric NETs; patients who had endoscopic submucosal dissection or endoscopic mucosal resection; patients who received neoadjuvant chemotherapy; patients who died within 3 months of surgery from postoperative complications; and patients with unknown tumour size or who were lost to follow-up

结局指标

主要结局

recurrence rate

时间窗: 60 months

distant, peritoneal, and local recurrence

次要结局

  • Incremental cost-effectiveness ratios (ICERs)(60 months)
  • Delayed-detection months(60 months)

研究者

发起方
Fujian Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chang-Ming Huang, Prof.

Director of gastric surgery

Fujian Medical University

研究点 (1)

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