跳至主要内容
临床试验/NCT07032961
NCT07032961招募中不适用

Screening for Gastric Pathologies in Elderly and High-Risk Populations Using a Mobile Capsule Gastroscopy System: a Prospective, Multicenter, Population Based Cohort Study

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2025年6月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10,000
试验地点
1
主要终点
Detection Rate of Gastric Diseases Using Mobile Capsule Gastroscopy

研究概览

简要总结

The goal of this is to learn about the effectiveness and feasibility of a novel AI- assisted Mobile Capsule Gastroscopy (MCG) system for detecting gastric pathologies in elderly and high-risk populations.

The main question it aims to answer is:

Can MCG effectively detect gastric pathologies, including common gastric diseases, gastric cancer, and precancerous lesions, in elderly and high-risk individuals at community health centers?

Participants will:

Epidemiological, diagnostic, and post-MCG follow-up data generated during participants' involvement in the gastric pathologies public screening program will be collected.

详细描述

Gastric diseases-including atrophic gastritis, gastric polyps, peptic ulcers, submucosal lesions, gastric cancer, and precancerous conditions-have become a major global public health challenge. In China, the prevalence of gastric ulcers is as high as 17.2%, significantly higher than that in Western countries (4.1%) [1]. Gastric cancer also ranks among the top globally in both incidence and mortality, with approximately 400,000 new cases and over 300,000 deaths each year [2-3]. Notably, around 80% of patients are diagnosed at an advanced stage, and the 5-year survival rate is less than 30% [4]. Studies have shown that early gastric cancer, if detected and treated promptly, can achieve a 5-year survival rate of over 90% [5]. Moreover, if benign conditions such as atrophic gastritis and peptic ulcers are not treated in time, they may progress into precancerous lesions or even malignancies [6]. Therefore, early screening and accurate diagnosis are key to reducing the disease burden of gastric disorders.

Although esophagogastroduodenoscopy (EGD) is considered the gold standard for gastric disease screening [7-8], its invasive nature, associated patient discomfort, and reliance on skilled endoscopists and specialized equipment limit its accessibility. In China, the scarcity of endoscopic resources in primary care settings, combined with low patient compliance, further restricts screening coverage and increases the risk of missed diagnoses [9-10].

In recent years, capsule endoscopy has emerged as a valuable complementary tool for gastrointestinal disease screening due to its non-invasive and user-friendly nature [6,7]. Among its modalities, magnetically controlled capsule gastroscopy (MCCG) provides comprehensive gastric visualization, with reported sensitivity and specificity of 90% and 92%, respectively, for common gastric lesions. However, its reliance on expensive magnetic navigation systems and trained operators limits its widespread adoption in community-based screening programs [8].

To address these limitations, a novel mobile-controlled capsule gastroscopy (MCG) system being more accessible and not requiring costly external magnetic control was developed. It consists only of a disposable capsule and a wireless portable receiver. Participants can complete the examination independently in community health centers or at home by following video instructions via a smartphone app and adjusting their body positions to guide the capsule. An AI algorithm ensures complete gastric coverage in real time. The video can be viewed directly on the smartphone and transmitted to the cloud for remote diagnosis. The MCG system is non-invasive, user-friendly, and compatible with remote diagnosis, making it well suited for gastric disease screening in community health centers. Compared with MCCG, MCG enables fully autonomous operation without magnetic navigation, substantially reducing technical complexity and healthcare costs. However, its diagnostic accuracy and real-world feasibility in community-based populations have yet to be validated through prospective studies.

In 2025, the Guangzhou Municipal Health Commission issued the 'Gastric Pathologies Screening Programme for the Elderly and High Risk Groups in Guangzhou Municipality'. Organized by the Commission and led by Southern Medical University Nanfang Hospital, with participation from Guangzhou First People's Hospital, The Second Affiliated Hospital of Guangzhou Medical University, Guangdong Provincial Hospital of Traditional Chinese Medicine, and others, the program will conduct screening and surveillance of 10,000 elderly and high-risk individuals in community health centers across Guangzhou.

研究设计

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

入排标准

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

入选标准

  • 1.Provision of written informed consent; 2.Participants of the 'Gastric Pathologies Screening Programme for the Elderly and High Risk Groups in Guangzhou Municipality', the following are the criteria for inclusion in this public welfare programme:
  • Elderly cohort: Permanent residents of Guangzhou aged ≥60 years who have not undergone specialized gastric disease screening in the past three years;
  • Or high-risk cohort: Individuals aged ≥45 years who meet at least one of the following risk criteria:
  • History of Helicobacter pylori infection (positive ¹³C/¹⁴C urea breath test);
  • Prior diagnosis of chronic atrophic gastritis, gastric ulcer, neoplastic gastric polyps, hypertrophic gastritis, or pernicious anemia;
  • Family history of gastric cancer (first-degree relative with a confirmed diagnosis);
  • Long-term high-salt diet, smoking history (≥20 pack-years), or heavy alcohol consumption (100 mL of distilled spirits/day).

排除标准

  • Not considered by the investigator to be suitable for participation in this study.
  • Meets the exclusion criteria of the Public Welfare Programme. Individuals will be excluded if they meet any of the following conditions:
  • (1)Known allergy to medical polymer materials; (2)Psychiatric disorders that interfere with procedural cooperation; (3)Pregnancy or lactation; (4)Severe systemic comorbidities (e.g., cardiovascular, respiratory, neurological diseases) affecting examination tolerance; (5)Inflammatory bowel disease (Crohn's disease or ulcerative colitis) or gastrointestinal diverticulosis; (6)Known or suspected gastrointestinal malformations, obstructions, strictures, or fistulas; (7)Clinically significant dysphagia; (8)Acute abdominal symptoms (e.g., pain, vomiting, suspected bowel obstruction, or severe constipation); (9)History of major gastrointestinal surgery (e.g., esophagogastrostomy, gastrojejunostomy); (10)Physical debilitation precludes postural changes or concurrent severe illness; (11)Medically ineligible for abdominal procedures or refusal to undergo them; (12)Deemed unsuitable for MCG by the investigator; (13)Refusal to provide informed consent; (14)Any other condition judged by the investigator to make the individual unsuitable for study participation.

结局指标

主要结局

Detection Rate of Gastric Diseases Using Mobile Capsule Gastroscopy

时间窗: At end of data collection phase (within 6 months of study launch)

This measure assesses the proportion of participants in whom MCG identifies common gastric diseases, gastric cancer, or precancerous lesions.

次要结局

  • Safety of MCG(Within 14days after MCG procedure)
  • Quality of MCG Examination(At end of data collection phase (within 6 months of study launch))
  • Procedural Compliance and Completion Rate(Immediately after MCG procedure)
  • Patient Satisfaction(Immediately after MCG procedure)
  • Cost-Effectiveness of MCG Screening(At end of data collection phase (within 6 months of study launch))
  • Diagnostic Agreement Between MCG and EGD (Kappa Value)(Within 30 days after MCG for participants referred for confirmatory EGD)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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