Introduction

With the need to reduce the burden of endoscopy, capsule sponge enables cost effective and efficient triage for patients with reflux as shown in the National Health Service England (NHSE) pilot study whilst achieving a smaller carbon footprint in comparison to gastroscopy. Negative sponge follow up has yet to be reported. Using the largest single UK site database, we describe 1, 2 and 3 year follow up and quantify the effect of gastroscopy avoidance on the endoscopic carbon footprint.

Aims & Methods

Patients routinely referred between November 2020 and November 2023 to gastroscopy or gastroenterology clinic with reflux were selected as part of the DELTA or NHSE pilot studies and triaged to a new nurse led early diagnosis teleclinic where they were first offered a capsule sponge. Patients with positive tests, (Trefoil factor 3 TFF3 and/or atypia/p53 positivity indicating possible Barrett’s/gastric intestinal metaplasia or dysplasia respectively) all underwent mandatory gastroscopy and were excluded from this analysis. In the event of a negative test, nurse led teleclinic follow up occurred by 3 months and gastroscopy was only requested for ongoing/concerning symptoms. The endoscopy database for patients with a negative capsule sponge was reviewed at 1, 2 and 3 year intervals to review if gastroscopy had occurred and what findings were identified.

Results

At the 1, 2 and 3 year follow up intervals, 429 and 204 and 41 patients were identified respectively. 86% of the 1 year follow ups (n=371) had not represented for a gastroscopy. The most frequent findings in the 14% (n=57) who did undergo gastroscopy were gastritis (n=14), hiatus hernia (n=9) and normal (n=16). The most significant finding in this cohort was one case of gastric cancer, identified two weeks post capsule due to new concerning symptoms. In total 371 gastroscopies were avoided in year 1, equating to 42294L of water and 1846 kgeCO2. Of the 204 2 year follow up group, 92% (n=187) had not had a gastroscopy. There was no significant pathology (including Barrett’s) identified in any of the remaining 8% (n=17) and the most common endoscopic conclusion in this cohort was normal. Only 2/17 patients underwent their gastroscopy in the second year of follow up. Finally, of the 41 patients with a negative capsule sponge available to review at 3 year follow up, 21% (n=9) had undergone a gastroscopy however only 3 of these had been performed in year 3 and they were all normal. Importantly, no patient who represented for OGD at any of the intervals after a negative capsule sponge were found to have Barretts.

Conclusion

Over 1, 2 and 3 year follow up periods, our study provides reassuring data from the largest UK capsule sponge site. Our data shows that capsule sponge safely excluded significant upper GI pathology in a less invasive manner, enabling symptomatic management without necessitating gastroscopy in the majority of patients. Nurse led teleclinic safety netting proved effective in identifying patients needing additional investigations whilst reducing the number of gastroscopies performed. This has helped improve endoscopy access overall, whilst also tackling the growing concern surrounding the endoscopic carbon footprint. Our study supports a new paradigm for the investigation of reflux symptoms which can be incorporated in both community and secondary care pathways.

References

Greenhouse gas reporting: conversion factors 2022. GOV.UK. Published
September 20, 2022. Accessed January 26,
2023. https://www.gov.uk/government/publications/greenhouse-gas-reporting-

Disclosure

None

Introduction

Due to pandemic restrictions we established a new early diagnosis service for patients with reflux symptoms and those on our existing Barrett’s surveillance programme using Cytosponge as initial investigation in 2020. As this was the first time Cytosponge had been used in routine clinical practice in this setting it was important to involve patients in the evaluation of the service.

Aims & Methods

The service was established in a district general hospital with catchment area 600,000. All patients who had a Cytosponge procedure between 01/05/2021 and 04/04/2023 were asked to complete a one-page survey about their experience on the same day as the procedure, prior to leaving the hospital. The survey contained demographic data and questions regarding their degree of discomfort using a visual analogue scale as well as whether they had had a previous endoscopy, and which one they preferred, if they thought the test was acceptable and whether they would be willing to have a Cytosponge again. There was also space for free text comments.

Results

829 patients completed the survey at least partially. No patients declined to participate. 393 (49.5%) were female, 401 Male(50.5%) 93% described themselves as white ethnicity 3.4% as Asian/Asian British, 1.2% as Black or Black British,2.2% as Mixed/other.
99.5% found the information leaflet helpful. Only 20/816 (2.5%) respondents felt that Cytosponge was an unacceptable test. 15% described no discomfort, 77% mild or minimal discomfort, 3% moderate discomfort, 5% severe/significant discomfort. 778 patients (94%) would be willing to have a Cytosponge again.
445/819 (54%) reported having a previous gastroscopy.329/383 (86%)reporting a preference preferred Cytosponge to gastroscopy.

Conclusion

These results support previous data from the BEST studies, and are the largest single site dataset showing the excellent acceptability of Cytosponge in the real-world setting. The evidence from patients for their preference for Cytosponge over gastroscopy will also give support for its use as in Barrett’s surveillance programmes going forward where multiple gastroscopies were previously required.

Introduction

Eosinophilic oesophagitis is a condition characterised by symptoms of dysphagia and/or food impaction in adults, with oesophageal histology showing a peak eosinophil count of >15 eosinophils/high power field (or >15 eosinophils/0.3mm2 or >60 eosinophils / mm2), and the absence of other causes¹. Recent BSG guidelines for the management of Eosinophilic oesophagitis (EOE) in adults recommend repeat endoscopy to ensure histological remission on treatment. This can require multiple procedures that are unpleasant for patients and are resource intensive. Capsule sponge is a minimally invasive oesophageal cell sampling technology that has been used in >15000 patients with Reflux symptoms and Barrett’s oesophagus. To date it has not been used in adults with EOE in clinical practice. The COSIE study is a pragmatic prospective ongoing study of adults with non-stenotic EOE to evaluate capsule sponge in routine clinical practice.

Aims & Methods

All adult patients attending a monthly dedicated EOE clinic May 2023 to April 2024 in a non-specialist hospital, were screened by a single consultant, Patients were offered capsule sponge and same day gastroscopy at least 8 weeks after starting or changing therapy or after three weeks from first diagnostic gastroscopy to monitor disease response and activity. The Endosign device was used in all patients. The Dysphagia Symptom Questionnaire, cytological and histological eosinophil count and Endoscopic reference score (EREFS) were measured as part of the ongoing study. Qualitative outcomes including success rate of swallowing, satisfactory cell sample (sufficient squamous cells), evidence of sponge reaching the stomach (columnar cells seen), complications and patient feedback and test preference were collected patient satisfaction questionnaire was collected after the procedure on the same day . All sponge cytology were processed by CYTED laboratories and endoscopic histology as part of normal clinical practice.

Results

138 patients with EOE attended the clinic between May 2023 and April 2024. 77 patients identified as suitable, 41/53 (75%) agreed to take part. 12/53 (25%) declined to take part in the study when our research nurse contacted them and 24 are awaiting testing. 31/41 (75.6%) were male and 10 (24.4%) females. Median age observed was 50 years, standard deviation 14.58, minimum was 19 years old and maximum age recorded was 72 years. Of the 41 patients who attempted to swallow capsule sponge 5 (12%) failed to swallow after 2 attempts. There have been no complications and no sponge detachments. 36 /41 (87.8%) agreed to same day gastroscopy. On same day gastroscopy examination, 20/ 36(55.5%) had minor grade I or II visible abrasions. No mucosal tears were evident. There was evidence of the capsule sponge reaching the stomach in 29/32 (90.6%). Adequate squamous cytological specimen were produced in 32/32 (100%). 36 (87.8%) patients found test acceptable of which 28/37 (75.6%) of those who expressed a preference preferred capsule sponge to gastroscopy.

Conclusion

The preliminary results show that capsule sponge is feasible to use in routine clinical practice and can be used safely to sample the oesophagus in non-stenotic EOE, providing sufficient samples. It is well tolerated and patients preferred capsule sponge to gastroscopy. Ongoing work will assess clinical effectiveness and management outcomes, comparative eosinophil counts and will contribute to a multicentre QUBIE (QUantitative Biomarker Identification for Eosinophilic oesophagitis) study to evaluate potential biomarkers in EOE.

References

Dhar A, Haboubi HN, Attwood SE, et al. British Society of Gastroenterology (BSG) and British Society of Paediatric Gastroenterology, Hepatology and Nutrition (BSPGHAN) joint consensus guidelines on the diagnosis and management of eosinophilic oesophagitis in children and adults. Gut 2022;71:1459-1487.

Introduction

The RefluxStop device is a novel surgical implant that aims to manage gastroesophageal reflux disease (GERD) by reinstating the normal structure of the antireflux barrier. The nonactive implantable device achieves this by restoring the acute angle of His and gastroesophageal flap valve while acting as a mechanical stop to prevent migration of the lower esophageal sphincter into the chest cavity. This study reports the safety and efficacy of 79 subjects that underwent the RefluxStop procedure.

Aims & Methods

After informed consent was obtained, a retrospective chart review of 79 GERD subjects managed by the RefluxStop procedure was performed at a single institution in Germany between July 2021 and November 2022. Outcome measures included assessment of symptoms and associated conditions, parameters of proton pump inhibitor (PPI) usage, evaluation of perioperative adverse events or complications, and GERD health-related quality of life (GERD-HRQL) score. These measures were used to evaluate the feasibility, safety, and clinical outcomes of the RefluxStop procedure in management of active GERD.

Results

79 subjects aged 49.8±14 years were followed after undergoing the RefluxStop procedure. The mean body mass index of subjects was 25.8±4.5. 49 of the subjects were male. Associated conditions observed preoperatively included esophagitis (45.6%), Barrett’s esophagus (17.7%), and hiatal hernia (57%). Hiatal hernias had a mean size of 2.9 cm with 35% of cases classified as large. Symptoms at baseline included general GERD symptoms (35.4%), heartburn (29.1%), cough (13.9%), regurgitation (11.4%), retrosternal burning (10.1%), hoarseness (5.1%), abdominal pain or pressure (3.8%), nausea (2.5%), and other less frequent manifestations. Preoperative GERD-HRQL score was 21.5±5.2 and patients had been using PPIs for a mean of 4.7±6.8 years before surgery. At a follow-up of 10.7±3.1 months postoperatively, all subjects demonstrated significant improvement in GERD-related symptoms including dysphagia. No subjects required postoperative esophageal dilatation or reoperation and only 2.5% of subjects required PPIs to manage persistent symptoms after surgery. Furthermore, no severe perioperative complications occurred. The mean GERD-HRQL score was significantly reduced to 1.6±3.2 at follow-up, exhibiting a 92.6% improvement from baseline.

Conclusion

This study provides additional evidence to support RefluxStop as a safe and effective management option in patients with GERD. Significant improvements in PPI use and health-related quality of life outcomes were observed after intervention. Further studies are needed to validate the role of RefluxStop in GERD management.

Introduction

Standard-of-care treatments for gastroesophageal reflux disease (GERD) include proton pump inhibitor (PPI)-based medical management and conventional antireflux surgery (i.e., Nissen fundoplication). However, these modalities are associated with a significant burden of unmet needs, such as irresponsiveness and postoperative adverse events (AEs), respectively. This study presents the results of 158 patients managed with RefluxStop in Germany.

Aims & Methods

One-hundred fifty-eight reflux patients were treated with RefluxStop between July 2021 and November 2023. Clinical endpoints included GERD Health-Related Quality of Life (GERD-HRQL), postoperative AEs, and change in PPI use.

Results

Baseline characteristics are shown in Table 1. Median GERD-HRQL score improved by 90.9% from a baseline of 22 (IQR 19-31.5) to 2 (IQR 0-2) at 20±7-month follow-up (p<.001). A 96.3% reduction in PPI use was also observed; baseline PPI use in 96.5% of n=113 decreased to 3.6% of n=110 at follow-up. All cases of preoperative dysphagia (n=18) resolved after surgery. New-onset dysphagia occurred in five patients (3.2%) postoperatively but did not require esophageal dilation. Hiatal hernia recurred in 1.3% (n=2) of patients and was managed with device repositioning. Device penetration and migration occurred in 1.3% (n=2) of patients due to excessively tight suturing of the fundic pouch in which the device was invaginated. One of these patients was later treated by Toupet fundoplication.

Table 1 Baseline characteristics

Conclusion

This report demonstrates the promising clinical effectiveness of RefluxStop as a novel treatment principle in management of GERD. Additional evaluation is necessary to enhance the evidence supporting this new antireflux procedure.

Disclosure

The authors disclose travel grants and speaking honoraria from Implantica (Zug, Switzerland).

Introduction

Endoscopy services in many healthcare systems face increasing demand, and novel approaches to patient triage are needed. Recent research suggests that capsule sponge testing combined with immunohistochemical biomarkers can prioritise patients with Barrett’s oesophagus (BO) and gastro-oesophageal reflux for oesophagogastroduodenoscopy (OGD).^1,2 However, it is not yet widely integrated into clinical practice globally. The capsule sponge is not currently used in South Wales and Northern Ireland, and further investigation into its implementation in these regions is required.

Aims & Methods

This multicentre feasibility study aimed to evaluate whether the capsule sponge could be used in Wales and Northern Ireland to triage patients with gastro-oesophageal reflux or BO for OGD, and to assess feedback from patients and staff. Patients referred to gastroenterology due to gastro-oesophageal reflux and patients with known BO under surveillance were eligible. Patients were recruited from 3 hospital sites in Wales and 2 in Northern Ireland, undergoing the test in nurse-led clinics between December 2024 and March 2025. Pathology samples were processed centrally in an accredited laboratory (Cyted), examining for TFF3 (suggestive of intestinal metaplasia), p53 and atypia (high-risk findings associated with dysplasia). Patient feedback was collected at the clinics, and feedback forms were also sent to patients and staff.

Results

201 patients were recruited, with 196 (97.5%) completing the capsule sponge test: 116 with BO (median age 59, 84% male) and 80 with reflux (median age 49, 56% female). 101 BO samples (87%) were adequate for analysis. Of these, 21 (21%) were positive/equivocal for atypia/p53 and deemed high-risk, and 80 (79%) were negative for both atypia and p53. High-risk patients were prioritised for urgent OGD, with the remainder followed-up as per the British Society of Gastroenterology guidelines. 61 samples (76%) from patients with reflux were adequate for analysis. Of these, 3 (5%) were positive/equivocal for atypia/p53 and prioritised for urgent OGD, 11 (18%) were TFF3 positive but negative for both atypia and p53 and were booked for routine OGD, and 47 (77%) were negative for all 3 biomarkers and were managed as per usual local practice.
148 patients (76%) who completed a capsule sponge test had previously had an OGD, with 78% of these preferring the capsule sponge, 4% preferring the OGD and 9% being unsure. Feedback forms were completed by 52 patients, with response rates varying by question. 92% rated the capsule sponge procedure good/very good, 3% fair and 5% poor/very poor. When asked how likely they would be to recommend the test, on a scale from 1 (least likely) to 10, patients with reflux gave a mean score of 8.7 and patients with BO 9.6. For whether they would be willing to have the test done again, 83% said yes, 14% not sure and 3% no. Patients’ free text comments indicated they found the capsule sponge to be quicker and easier than an OGD, however some experienced discomfort on sponge withdrawal. 14 staff completed feedback forms. 100% agreed the capsule sponge test was easy to deliver, and 100% rated the implementation of the test pathway as good/very good.

Conclusion

This feasibility study showed that the capsule sponge could successfully triage patients under BO surveillance or with reflux for OGD in Wales and Northern Ireland, with positive feedback from patients and staff. These findings support future integration of the capsule sponge into clinical pathways in these regions, with potential transferability to other healthcare systems internationally.

References

1. Chien S, Glen P, Penman I, Cruickshank N, Bryce G, Crumley A, et al. Oesophageal cell collection device and biomarker testing to identify high-risk Barrett’s patients requiring endoscopic investigation. Br J Surg. 2024 May 13;111(5):znae117.
2. Chien S, Glen P, Bryce G, Cruickshank N, Penman I, Robertson K, et al. Clinical application of capsule sponge testing in symptomatic reflux disease: a national prospective cohort study. BMC Gastroenterol. 2024 Nov 26;24:431.

Disclosure

R McNally, B Afinowi, I Aldred and R Hardwick are employed by Cyted Health, who manufacture the capsule sponge device used in this study. The remaining authors have nothing to disclose.