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Table 3 Inclusion and Exclusion criteria for the BEST3 trial

From: Barrett’s oESophagus trial 3 (BEST3): study protocol for a randomised controlled trial comparing the Cytosponge-TFF3 test with usual care to facilitate the diagnosis of oesophageal pre-cancer in primary care patients with chronic acid reflux

Inclusion criteria

Exclusion criteria for

BEST3 data collection

Cytosponge procedure

Upper GI endoscopy

• Male and female

• Aged ≥50

• Records of ≥6 months of prescription for acid-suppressant medication in the last year

• Recorded regular prescriptions of NSAIDs

• Recorded upper GI endoscopy in the previous 5 years as identified from the practice database

• Recorded diagnosis of a current or previous oro-pharynx, oesophageal or gastro-oesophageal tumour

• Recorded diagnosis of BE

• Unable to attend the GP surgery

• Deemed not fit enough by their GP, including lacking capacity

• Meeting the guidelines for an urgent endoscopy referral according to NICE guidelines

• Recorded diagnosis of an oro-pharynx, oesophageal or gastro-oesophageal tumour (T2 staging and above), or symptoms of dysphagia

• Difficulty in swallowing due to a known cerebrovascular accident or neurological disorder

• Recorded oesophageal varices, cirrhosis of the liver

• Inability to temporarily discontinue anti-thrombotic medication prior to procedure

• Having eaten and drank within the preceding 4 h

• Received prior surgical intervention to the oesophagus

• Known pregnancy

• Lacking capacity to provide informed consent

• Upper GI endoscopy during the study period

• Severe hypertension (e.g. systolic > 200 diastolic > 100)

• Myocardial infarction or any cardiac event within the previous 6 months

• Cerebrovascular event or other neurological disorder where swallowing has been affected within the previous 6 months

• Any previous treatment such as Photodynamic therapy (PDT) or Radio Frequency Ablation (RFA) to the oesophagus

• Anticoagulation therapy/ medication on day of procedure (warfarin, heparin or tinzaparin) according to local guidelines

• Other medical condition: low platelets or blood abnormalities that may cause excessive bleeding post procedure

• Eaten or drank within the previous 6 h

• Preference for sedation and has not brought anyone to accompany them at home. Follow local guidelines

• Known pregnancy

• Lacking capacity to provide informed consent