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随机对照试验比较基于血清学风险的上消化道内镜与现有钡餐荧光透视胃癌筛查系统的成本:用血清学检查标记的胃癌筛查替代基于年龄的胃癌有组织筛查系统(GALAPAGOS 研究)。

Randomized controlled trial comparing the costs of gastric cancer screening systems between serological risk-based upper gastrointestinal endoscopy and the existing barium photofluorography: gastric cancer screening labeled by serum examination in place of aged gastric cancer organized screening systems (GALAPAGOS study).

机构信息

Department of Gastroenterology, Cancer Institute Hospital, 3-8-31 Ariake, Koto-Ku, Tokyo, 135-8550, Japan.

Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.

出版信息

Gastric Cancer. 2024 Jan;27(1):36-48. doi: 10.1007/s10120-023-01449-3. Epub 2023 Nov 25.

Abstract

BACKGROUND

Although the risk of gastric cancer can be stratified according to Helicobacter pylori (H. pylori) IgG antibody titer and pepsinogen levels (ABC classification), a population-based gastric cancer screening system combining serological tests and endoscopy has not been introduced. This study aimed to compare the total testing cost per participant between the ABC classification method and the existing protocol.

METHODS

Using the minimization method with sex and age as allocation factors, 1206 participants were randomly assigned to the following two methods for a 5-year intervention: barium photofluorography as primary examination followed by detailed examination with upper gastrointestinal endoscopy (Ba-Endo) and risk-based upper gastrointestinal endoscopy by ABC classification (ABC-Endo). The primary endpoint was the total testing cost per participant over a 5-year period. The secondary endpoint was the expense required to detect one gastric cancer.

RESULTS

The total testing cost per participant was 39,711 yen in Ba-Endo (604 participants) and 45,227 yen in ABC-Endo (602 participants), with the latter being significantly higher (p < 0.001). During the intervention period, gastric cancer was found in 11 and eight participants in Ba-Endo and ABC-Endo, respectively. The expenses required to detect one gastric cancer were 2,240,931 yen in Ba-Endo and 3,486,662 yen in ABC-Endo.

CONCLUSIONS

The testing cost per participant turned out to be higher in the ABC-Endo group than in the Ba-Endo group. This superiority trial, based on the hypothesis that the cost of testing is lower for ABC-Endo than for Ba-Endo, was rejected.

摘要

背景

尽管根据幽门螺杆菌(H. pylori)IgG 抗体滴度和胃蛋白酶原水平(ABC 分类)可以对胃癌风险进行分层,但尚未引入结合血清学检测和内镜的基于人群的胃癌筛查系统。本研究旨在比较 ABC 分类法和现有方案中每位参与者的总检测成本。

方法

使用最小化方法,以性别和年龄为分配因素,将 1206 名参与者随机分配到以下两种方法进行 5 年干预:钡剂荧光摄影作为初步检查,然后进行上消化道内镜(Ba-Endo)详细检查和基于 ABC 分类的风险上消化道内镜检查(ABC-Endo)。主要终点是 5 年内每位参与者的总检测成本。次要终点是检测一个胃癌所需的费用。

结果

Ba-Endo(604 名参与者)中每位参与者的总检测成本为 39711 日元,ABC-Endo(602 名参与者)中为 45227 日元,后者明显更高(p < 0.001)。在干预期间,Ba-Endo 和 ABC-Endo 中分别发现了 11 名和 8 名参与者患有胃癌。检测一个胃癌所需的费用分别为 Ba-Endo 中的 2240931 日元和 ABC-Endo 中的 3486662 日元。

结论

ABC-Endo 组每位参与者的检测成本高于 Ba-Endo 组。基于 ABC-Endo 的检测成本低于 Ba-Endo 的假设,这项优越性试验被拒绝。

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