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

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.

Globally, gastroesophageal cancer account for over 10% of incident cancers, affecting the life of more than a million new people every year. While this cancer is a global phenomena, nearly 40% of new cases worldwide are concentrated in China, counting for more than 1.1 million new diagnosis and more than 870,000 deaths only in 2015. While incidence of gastroesophageal cancer is about double in rural areas when compared to urban centres, the mortality rate is almost three times higher. This is due to the 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.

Screening programmes have been shown to be effective in reducing the mortality rate through early detection. Typically, screening for gastroesophageal cancer uses a video endoscope system consisting of a flexible endoscope, video processor, light source and instrument hub, and liquid crystal display monitor. These systems are appropriate in modern medical settings, but many issues hinder their usage in rural and underdeveloped areas: high capital costs, limited portability, vulnerable electronics, and reprocessing concerns along with lack of sterilisation facilities.

In order to reduce the larger proportion of patients diagnosed with cancer at a later stage in rural and underdeveloped areas in China and other low-and middle-income countries (LMICs), there is a pressing need to develop cost-efficient and sustainable technologies for endoscopic gastroesophageal cancer screening.

With a compact footprint, minimal cost of disposable parts, and use of available local resources, the platform we propose would enable cancer-screening programmes in LMICs, particularly in rural or remote areas with limited access to medical infrastructure. Our solution is intended as a pure diagnostic tool with the intent of identifying suspicious lesions optically and then triaging patients to a regional or central urban endoscopy centre for traditional therapeutic endoscopy with biopsies/mucosal resection. With our technology, we are targeting a population that would otherwise not be screened and be subject to high disease incidence and mortality due to the numerous barriers to standard flexible endoscopic screening in rural areas of China.

Autonomous navigation, based on visual servoing and proprioceptive sensing, would allow the system to move the capsule with no input from an external operator. Integration of intelligent cancer feature recognition would enable direct diagnosis by the platform, thus preventing the need for a gastroenterologist on site to perform the procedure. Healthcare professionals without a specific training in gastroenterology, nurses, or even volunteers would be able to administer the screening exam, recording the images for later examination. Once the team is back at a central hospital, a gastroenterologist can review the suspicious lesions highlighted by the feature recognition software and decide if further diagnostic examination is needed.

In order to maximise the impact of the proposed research, we have conceived a specific strategy for the Chinese socio-economical landscape that starts from the identification of potential users and evolves in three different phases: a pre-clinical stage (Y1..Y3 - during this project), a clinical trial stage (Y4-Y5), and a commercialization stage (Y5 and beyond).

If successful, this research will establish a feasible model for upper gastrointestinal cancer screening at an ultra-low cost that can be implemented in rural and underserved areas. This approach can be extended to other LMICs (nearly 70% of gastric and oesophageal cancer cases are concentrated there) or even to modern healthcare systems, where relevant cost savings may be achieved.