Ultra-low-cost endoscopy for gastric cancer screening in rural China

我们建议优化、评估和验证一种新型便携式平台，该平台旨在实现偏远地区的超低成本胃食管癌筛查，重点关注中国农村和不发达地区，这些地区的胃食管癌发病率和死亡率非常高。胃癌和食管癌是全球死亡率最高的癌症。全球超过三分之一的新增病例集中在中国。仅在2015年，中国就有超过100万人被诊断患有这种癌症，超过87万人死于这种疾病。筛查方案已被证明通过早期发现在降低死亡率方面极为有效，但在资源匮乏的环境和农村地区实施费用昂贵且困难。这在中国尤其重要，因为医疗资源向城市地区的不公平分配（占人口的30%，但获得70%的医疗资源），农村地区医生短缺以及距离更远，导致癌症生存率差距很大。虽然与城市中心相比，农村地区胃癌和食道癌的发病率约为城市中心的两倍，但死亡率约为城市中心的三倍。为了减少中国农村和欠发达地区晚期癌症诊断患者的比例，迫切需要开发具有成本效益和可持续的内镜胃癌和食管癌筛查技术，这是该项目的重点。凭借我们在机器人胶囊内窥镜领域的开创性工作，我们的团队开发了一种新型的一次性，软绳，可吞咽，该项目的目的是在低收入和中等收入国家的农村地区进行具有成本效益的胃食管癌筛查。设计创新包括用于移动性和可视化的喷水驱动、便携式平台和一次性组件。每次手术后，胶囊外壳和软系绳被丢弃，而内窥镜摄像机被回收，无需再处理。微型拴系“药丸相机”有助于舒适的非镇静癌症筛查检查（每程序的目标成本为2英镑，资本成本约为100美元）。400英镑对现有技术的80，000英镑）。拟议的平台被设计成适合一个手提箱（航空公司随身携带的大小，10公斤）。基于我们的初步结果，通过这项研究，我们将测试我们平台的临床诊断能力与标准胃镜检查相当的假设，同时农村环境的可靠性，可用性和便携性显着提高。我们将通过以下方式实现这一目标：（1）改善胶囊内窥镜的运动范围;（2）优化胶囊的可控性和稳定性;（3）使用机载摄像头采集的图像指导自主探索和病变检测;（4）在多个验证场景中将所提出的技术与标准胃镜进行基准测试，从实验室测试到中国河北省农村地区的临床前田间试验，（5）收集所需的临床前文件以启动临床试验。我们的长期目标是为中国农村地区制定一项胃食管癌筛查计划，该计划建立在源于该提案的技术和实验证据的基础上。我们的目标是使我们的研究成为一个平台，以超低成本建立一个可行的上消化道癌症筛查模型，可以在农村和资源匮乏的地区实施。这种方法可以扩展到其他低收入和中等收入国家（近70%的胃癌和食管癌病例集中在这些地区），或者同样扩展到现代医疗保健系统，通过在日托单位进行筛查可以节省成本。

We propose to optimise, assess, and validate a novel portable platform designed to enable ultra-low-cost gastroesophageal cancer screening in remote settings, with a focus on rural and underdeveloped areas of China where this disease has a very high incidence and mortality.Gastric cancer and oesophageal cancers have the highest global mortality rates among other forms of cancer. More than one third of new cases worldwide are concentrated in China. Only in 2015, more than one million people were diagnosed with this form of cancer in China and more than 870,000 have died because from the morbidity. Screening programmes have been shown to be extremely effective in reducing the mortality rate through early detection, but are expensive and difficult to implement in low-resource settings and rural areas. This is particularly relevant in China, where inequitable distribution of medical resources to urban areas (which contain 30% of the population but receive 70% of the medical resources), shortage of doctors in rural regions and greater distance to access them translate into a very large cancer survival divide. While incidence of gastric and oesophageal cancers is about double in rural areas when compared to urban centres, the mortality rate is about three times higher. In order to reduce the larger proportion of patients diagnosed with cancer at a later stage in rural and underdeveloped areas in China, there is a pressing need to develop cost-efficient and sustainable technologies for endoscopic gastric and oesophageal cancer screening, which are the focus of this project.Leveraging our pioneering work in the field of robotic capsule endoscopes, our team has developed a novel disposable, soft-tethered, swallowable, endoscopic capsule, with the aim of enabling cost effective gastroesophageal cancer screening in rural areas of low- and middle-income countries. Design innovations include water-jet actuation for mobility and visualization, a portable platform, and disposable components. After each procedure, the capsule outer shell and soft tether are discarded, while the endoscopic camera is reclaimed without reprocessing. The miniature tethered "pill camera" facilitates a comfortable unsedated cancer screening exam (target cost per procedure £2 and capital cost ca. £400 vs £80,000 for existing technology). The proposed platform is designed to fit in a single suitcase (airline carry-on size, 10kg). Building upon our preliminary results, with this study we will test the hypothesis that the clinical diagnostic capabilities of our platform are comparable to standard gastroscopy, while the reliability, usability, and portability for rural settings are significantly improved. We will pursue this goal by (1) improving the range of motion of our endoscopic capsule, (2) optimizing the controllability and the stability of the capsule, (3) using the images acquired by the on-board camera to guide autonomous exploration and detection of lesions, (4) benchmarking the proposed technology with standard gastroscopy in multiple validation scenarios, spanning from laboratory testing to pre-clinical field trials in the rural setting of Hebei province, China, (5) assembling the required pre-clinical documentation to initiate clinical trials. Our long-term goal is to develop a gastroesophageal cancer screening programme for rural China, which builds upon the technology and the experimental evidence originating from this proposal. We aim for our research to become a platform for establishing a feasible model for upper gastrointestinal cancer screening at an ultra-low cost that can be implemented in rural and poorly resourced areas. The approach can be extended to other low- and middle-income countries (nearly 70% of gastric and oesophageal cancer cases are concentrated in these areas) or equally to modern healthcare systems, where cost savings may be achieved through performing screening in day care units.