Capsule sponge testing to support earlier diagnosis of oesophageal cancer
On this page
If you're a member of the public, check out our public facing information about capsule sponge testing
Capsule sponge, also known as ‘pill on a string’, has been developed over the last 20+ years by Cancer Research UK funded researchers. There are now a few different capsule sponge technologies in use, including Cytosponge and Endosign. The device is used to sample cells from the lining of the oesophagus before they are tested for cell changes that may be a precursor to oesophageal cancer, called Barrett’s oesophagus.
Capsule sponge testing has the potential to improve patient experience and endoscopy (including gastroscopy) capacity. Studies are underway across the UK to evaluate capsule sponge testing in different use cases.
For more information about the recognition and referral of oesophageal cancer, see our 2-page oesophageal cancer insight guide for health professionals.
How do capsule sponge tests work?
An applicator houses a small capsule containing a sponge attached to a surgical string. The capsule is swallowed and dissolves in the stomach. The sponge is retrieved after a few minutes by pulling on the string. As the sponge moves up through the oesophagus it collects cells from the oesophageal lining which are assessed for markers of Barrett’s oesophagus or oesophageal cancer.
This video shows the test being performed:
Advantages and disadvantages of capsule sponge
Advantages
|
Capsule sponge testing may improve patient experience, which could reduce did not attend (DNA) rates along the pathway. Compared to gastroscopy it is: |
|
Test can be performed by different types of health professionals once trained. |
|
|
High levels of patient and clinical acceptability have been reported [1,2]. |
|
|
Pilot results demonstrate the potential of capsule sponge to reduce endoscopy workload. |
|
|
Capsule sponge has been reported as cost-effective compared to usual care in evaluations. |
|
|
|
Capsule sponge could be offered as an alternative to people who may be contraindicated for gastroscopy (eg people with frailty or comorbidities). |
Disadvantages
|
Adverse effects have been reported, including abrasion, incomplete swallowing, sore throat and detachment of the capsule sponge. |
|
Data suggest that Barrett’s oesophagus may be missed in approximately 19-27% of those with a negative capsule sponge result [1,3]. |
|
|
There is little evidence demonstrating that capsule sponge could be used as a tool to detect oesophageal cancer earlier or that it improves oesophageal cancer outcomes. |
|
|
Implementing capsule sponge for proactive case-finding could increase workload pressures in primary care and diagnostic centres. |
Capsule sponge pilot studies and national evaluations across the UK
The capsule sponge test is being evaluated in three different use cases:
- Triaging patients with upper GI symptoms waiting for gastroscopy in secondary care
- Surveillance in people with Barrett’s oesophagus
- Targeted or proactive case-finding of Barrett’s oesophagus in people at high risk in a primary or community care setting
The image below shows these applications of capsule sponge in the oesophageal cancer recognition and referral pathway in primary care.
Studies investigating capsule sponge testing in various use cases are underway across the UK. Click the blue boxes below to find out more about evaluations of each of the different use cases.
National evaluations have been completed in England and Scotland (links are external). Key findings include:
- Significant reduction in endoscopy demand (78% in England, 77% in Scotland).
- The test is deemed safe and acceptable. No adverse events occurred and high patient and clinician acceptability was reported.
- Both evaluations demonstrated cost saving in comparison to usual care.
- Data from the evaluation in England showed there were relatively long wait times between capsule sponge test completion and the patient receiving their results. This reduced from a median of 55 days to 43 days throughout the evaluation.
Areas that require further evaluation and research include:
- The diagnostic accuracy of capsule sponge for detecting oesophageal cancer
- How the use of capsule sponge may impact patient outcomes.
- How capsule sponge testing may impact inequalities in access.
Capsule sponge has been accepted into business as usual across NHS Scotland for the investigation of people with reflux in secondary care. In England, funding is available via Cancer Alliances. Find out more in our 'What’s next?' section.
Evaluations are currently underway, and some completed, in all four UK nations. Scotland is the only UK nation with published evaluation data investigating capsule sponge use in Barrett’s oesophagus surveillance. Key findings include:
- Significant reduction in endoscopy demand
- Capsule sponge successfully identified high risk patients for further investigation
- Evidence of reduced waiting times for high-risk patients between final surveillance endoscopy and start of treatment.
- Cost-savings were identified compared to usual care.
Following the national evaluation, Scotland announced that capsule sponge testing will be introduced across all mainland Scottish health boards for the surveillance of people with Barrett’s oesophagus. It is currently implemented in 5 health boards.
For an overview of the national evaluations, and the impact on integrating capsule sponge testing into the health service, see the table below.
| UK Nation | Overview | Outcome |
| Scotland |
Scottish Health Technologies Group (SHTG) (link is external) |
The CytoScot team published two papers based on the evaluation [4,5]. Following the national evaluation, Scotland announced that capsule sponge testing will be used across all mainland Scottish health boards for the surveillance of people with Barrett’s oesophagus. It is currently implemented in 5 health boards. The adoption of capsule sponge testing is noted in Scotland’s 3-year Cancer Action Plan. |
| England | NHS England began a pilot in 2021 as part of project DELTA (link is external) | Results are not publicly available for this yet. |
| Northern Ireland |
The Western Trust is taking part in the DELTA study (link is external) |
This study is ongoing, so results are not available. |
| Wales | Pilots funded by Moondance are underway at two sites (Wrexham Maelor and Powys Hospital) (link is external) |
This study is ongoing, so results are not available. |
Currently, gastroscopy is still the gold standard diagnostic test used for surveillance in people with Barrett’s oesophagus [6].
In 2023, NICE published guidance which concluded that the evidence base was insufficient to determine whether capsule sponge testing is suitable for surveillance in people with Barrett’s oesophagus [7]. In addition, The European Society of Gastroenterology does not recommend the use of non-endoscopic tools, such as capsule sponge, for the surveillance of Barrett’s oesophagus [8].
Pilot projects as part of CYTOPRIME2 (link is external) are underway in some areas of England to evaluate capsule sponge in primary and community care settings to proactively identify and test those at higher risk of Barrett’s oesophagus and oesophageal cancer. The DELTA Project (link is external) also aims to use Cytosponge for proactive case finding in people with gastrointestinal reflux. Results are not publicly available for these projects yet.
BEST4 (2022-2035) (link is external), jointly funded by Cancer Research UK and the National Institute for Health and Care Research, will explore if capsule sponge testing can prevent deaths from oesophageal cancer when offered as a screening test to people on long-term medication for heartburn.
The European Society of Gastroenterology recommended in 2023 that capsule sponge can be used as an alternative to endoscopy for case finding of Barrett’s oesophagus [8].
What’s next for capsule sponge?
Further activity is required to support the implementation of capsule sponge for different use cases.
Research and evidence
- Evaluations should be published in a timely manner, which outline clear recommendations and next steps.
- There is a need for clinical guidance to outline how capsule sponge testing could be integrated into health systems.
- Further real-world data is required to evaluate capsule sponge testing in practice, focusing on how capsule sponge testing improves patient outcomes.
- Further research to assess and compare different capsule sponge devices will reduce the potential risk of bias in existing studies.
Health system preparation
Capsule sponge testing is being rolled out across all health boards in Scotland. In Wales and Northern Ireland, there isn’t a pathway for capsule sponge implementation yet.
In England, there’s no national funding stream for capsule sponge testing, but funding is available to support Cancer Alliances to integrate capsule sponge as part of their service. NHS Trusts can work with their local Cancer Alliance to write a business case and explore funding options.
In all nations health systems can prepare to ensure future activity is successful:
- ensure clinicians are fully informed of any changes
- referral forms should include capsule sponge if available
- capsule sponge results should be presented in Electronic Health Records
- appropriate estates and equipment to integrate alternative diagnostics
- provide clinical guidance covering the process of capsule sponge testing
- continued evaluation of the intervention to ensure best practice is implemented
Finally, health systems should engage with each other to share learnings to ensure implementation is effective.
Innovation
Evidence is emerging to assess how Artificial Intelligence (AI) deep-learning models might be used in analysing samples collected from capsule sponge testing. AI has the potential to support pathology services, by building in efficiencies and reducing demand on workforce [9,10,11,12]. Further research is needed to assess whether an AI tool can detect oesophageal cancer.
References
- Kadri SR, et al. Acceptability and accuracy of a non-endoscopic screening test for Barrett’s oesophagus in primary care: cohort study. BMJ. 2010 Jan 25;341(sep10 1):c4372–2.
- Fitzgerald RC, et al. Cytosponge-trefoil factor 3 versus usual care to identify Barrett’s oesophagus in a primary care setting: a multicentre, pragmatic, randomised controlled trial. The Lancet [Internet]. 2020 Aug 1;396(10247):333–44.
- Ross-Innes CS, et al. Evaluation of a Minimally Invasive Cell Sampling Device Coupled with Assessment of Trefoil Factor 3 Expression for Diagnosing Barrett’s Esophagus: A Multi-Center Case–Control Study. Franco EL, editor. PLOS Medicine. 2015 Jan 29;12(1):e1001780
- Chien S, et al. Oesophageal cell collection device and biomarker testing to identify high-risk Barrett's patients requiring endoscopic investigation. Br J Surg. 2024 May 3;111(5):znae117.
- Chien S, et al. CytoSCOT group. National adoption of an esophageal cell collection device for Barrett's esophagus surveillance: impact on delay to investigation and pathological findings. Dis Esophagus. 2024 Apr 27;37(5):doae002.
- di Pietro M and Fitzgerald RC. Revised British Society of Gastroenterology recommendation on the diagnosis and management of Barrett’s oesophagus with low-grade dysplasia. Gut. 2017 Apr 7;67(2):392–3.
- Barrett's oesophagus and stage 1 oesophageal adenocarcinoma: monitoring and management, NICE, 2023. https://www.nice.org.uk/guidance/ng231
- Diagnosis and management of Barrett esophagus: European Society of Gastrointestinal Endoscopy (ESGE) Guideline, 2023. https://www.bsg.org.uk/getmedia/88cfdd3f-2593-4cd5-bb9a-ff1c1d4e0c61/ESGE-Barretts-Guideline.pdf?ext=.pdf
- Bouzid K, et al. Enabling large-scale screening of Barrett’s esophagus using weakly supervised deep learning in histopathology. Nature Communications [Internet]. 2024 Mar 11 [cited 2024 Mar 21];15:2026.
- Gehrung M, et al. Triage-driven diagnosis of Barrett’s esophagus for early detection of esophageal adenocarcinoma using deep learning. Nat Med 27, 833–841 (2021).
- Pilonis ND, et al. 2022 Use of a Cytosponge biomarker panel to prioritise endoscopic Barrett's oesophagus surveillance: a cross-sectional study followed by a real-world prospective pilot Lancet Oncoloy Vol:23: 2, p270-278
- Berman, A.G., et al. (2022). Quantification of TFF3 expression from a non-endoscopic device predicts clinically relevant Barrett’s oesophagus by machine learning. eBioMedicine, 82, p.104160.