ResultsRecruitment• 507 out of 4417 patients were eligible to take part in the study• 131 of them (25.5%) participated in the study

Demographics• Male-female ratio was 1.1:1• Mean age was 61.7 years• The mean BMI was 30.5 (range 20-48) for males and 29.6 (range 20- 48) for females• The mean waist to hip ratio was 0.95 (moderate risk) for males and 0.83 for females (moderate risk)

Aim

The overall purpose of the Barrett’s Oesophagus Screening Trial (BEST) is to determine the ability of the capsule sponge test to diagnose Barrett’s oesophagus in a primary care setting in comparison with the gold standard endoscopy. 500 individuals with a history of reflux will be recruited

Primary endpoints:• Recruitment rates including demographics of participants and feasibility of

identifying an at-risk population in general practice• Acceptability of the screening test in a primary care population • Potential psychological harms associated with the screening testSecondary endpoint: • Increase sensitivity and specificity of test by employing novel biomarkers

The data presented here are the pilot data from GP surgeries in East Anglia

Demographics

A pilot feasibility study of screening for Barrett’s oesophagus with a novel non-endoscopic capsule sponge device in a primary care setting  

S. R. Kadri*1 , I. Debiram1, M Das1, P. Lao-Sirieix1, M. O'Donovan1, J. M. Blazeby2, H. Morris3, F. Walter4, J. Emery5, R. C. Fitzgerald1

1Cancer Cell Unit, Hutchison-MRC Research Centre, Cambridge, 2Dept of Surgery and Dpt. of Social Medicine, University of Bristol, Bristol, 3Cancer Cell Unit, General Practice and Primary Care Research Unit, 4Cancer Cell Unit, General Practice and Primary Care Research Unit, Cambridge, United Kingdom, 5Cancer Cell

Unit, University of Western Australia, Perth, Australia

Methodology

Study inclusion criteriaarched to identify • Patients 50-70 years old • Received acid suppressant therapy for >3 months in the last 5 yearsExclusion criteria • Patients who had undergo endoscopy in the past one year• Patients known to have Barrett’s oesophagus• Patients with significant co-morbid diseases

• Reflux symptoms were assessed using a validated reflux questionnaire • Patients completed the Spielberger state-trait anxiety inventory (STAI) , Cancer worry scale questionnaires at day 0, 7 and 90 to assess the impact of screening on anxiety.• Acceptability of the capsule sponge was measured using a 10 point visual analogue scale (0 is unpleasant and 10 is enjoyable) at day 0 ,7 and day 90

• 25% of contacted patients participate in this screening study. This response is similar to the response noted in the previous primary care reflux related questionnaire study 5

• Screening did not induce unnecessary general anxiety. Patients had only short lived anxiety related to a diagnosis of Barrett’s oesophagus

• The capsule sponge is safe and was well tolerated

• These pilot data are encouraging for the ongoing study

Contact: sk543@hutchison-mrc.cam.ac.uk

0Fitzgerald Group

• 94/129 (73%) had ongoing reflux and 12 (9%) had symptoms more than once a day.• 19(15%) had poorly controlled symptom despite being on medication

Conclusion

Acceptability of capsule sponge device

AcknowledgmentsWe wish to thank the patients who generously helped with this study and staff of the Clinical Investigation Ward. This purpose-built facility has enabled the research team to conduct the study in a safe clinical environment and with participant numbers not otherwise possible in a hospital setting

 

Reflux symptoms

Anxiety associated with Screening

Feelings about Barrett’s Oesophagus

Day 0 Day 7 Day 90P <0.001 P <0.001

Between Day 0 & day 90 P <0.001

Day 0 Day 7 Day 90P= 0.517 P = 0.6087

Between Day 0 & day 90 P = 0.6273

Sample staining

• Patients general anxiety levels were not increased by undergoing screening but their anxiety related to a diagnosis of BE increased significantly at day 7 (p<0.0001) and reverted back to baseline at day 90

• The acceptability rating was 6 (range 2-10) on the day of the test, 5.5 (range 2-8) on the 7th day and 4.5 (range 2- 7) out of 10 on day 90• 2 failed to swallow the sponge• There were no adverse affects

  Sensitivity % Specificity % PPV% NPV% Correct

Proportion %

Alcian blue (AB) 68 96 94 76 82

TFF3 28 88 70 56 59

Mcm combination1 (M 1) 60 65 63 63 63

Mcm combination1 (M2) 60 62 60 62 61

Mcm 2 alone 56 50 54 52 53

TFF3 and AB 72 88 86 77 80

M1 intensity > 2 44 96 92 64 71

M1 and AB and TFF3 84 62 68 80 73

M2 and AB and TFF3 88 62 69 84 75

AB and TFF3 and M1 intensity >2

80 85 83 81 82

AB and M1intensity > 2 76 92 90 80 84

Capsule sponge device

Introduction

•Barrett’s oesophagus occurs in 2-4% of the population and is undiagnosed in majority of the cases•In order to reduce population mortality from oesophageal cancer systematic diagnosis of Barrett’s oesophagus through screening merits consideration•Population screening using endoscopy is not recommended due to logical and cost considerations•We have developed a non-endoscopic screening test using a capsule sponge device.•Sample collected from this then tested with immunocytological markers specific for Barrett’s oesophagus (Lao-Sirieix et al. Gut, 2007)

• The best combination of biomarkers were Alcian blue and M1 intensity >2• It yielded a sensitivity of 76% and a specificity of 92%

This device is MHRA approved in April 2008 (Patent number : W007/045896)

Visual analogue scale:

Mean score

0

Research Supported by

Biomedical Research Centre

Prevalence of Barrett’s Oesophagus in our ongoing study

• Prevalence of Barrett’s oesophagus with intestinal metaplasia was 4 (3%) out of 129 on endoscopy. Male to Female ratio was 1:1 and the mean age at diagnosis was 60 yrs

• Diagnosis of BE was made in 3 out of 4 using the sample obtained from the capsule sponge device using the best combination of biomarkers. All 3 patients diagnosed on sponge test had length of BE ≥ 2cm circumference and one patient who could not be diagnosed had < 2cm circumference of BE on endoscopy