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. 2014 Oct 1;2014(10):CD008760. doi: 10.1002/14651858.CD008760.pub2

Ishiguro 2012.

Study characteristics
Patient sampling Cross‐sectional cohort (screening cohort + surveillance cohort); prospective single‐centre study
Patient characteristics and setting Participants: 29 participants (19 screening, 10 surveillance). 1 person excluded because the capsule did not reach the oesophago‐gastric junction. 9 men, mean age 66 ± 6.6 years.
Baseline diagnosis: aetiology: 5 HCV, 4 alcohol, 1 primary biliary cirrhosis, 17 hepatocellular carcinoma, 2 other.
Disease severity: 14 Child‐Pugh score A, 14 Child‐Pugh score B, 1 Child‐Pugh score C.
Inclusion criteria: aged ≥ 18 years, prior endoscopic confirmation of oesophageal varice and currently under clinical surveillance, or suspected portal hypertension with current endoscopic screening for oesophageal varice.
Exclusion criteria: history of (or current) dysphagia; known oesophageal diverticulum; known or suspected intestinal obstruction; pregnancy; history of gastrointestinal surgery other than uncomplicated cholecystectomy or appendectomy; having an implanted cardiac pacemaker or any other electro‐medical device and any condition that might preclude compliance with the study or the PillCam ESO instructions, or both.
Index tests Index test: endoscopic capsule. PillCam ESO; Given Imaging, Yokneam, Israel.
Criteria for oesophageal varices: Japanese endoscopic classification system.
Operator: 3 experienced endoscopists who were blinded to each participant's history, with the exception of liver cirrhosis.
Target condition and reference standard(s) Target condition: presence of any and large oesophageal varices. Presence of red marks.
Reference standard: oesophago‐gastroduo‐denoscopy.
Criteria for oesophageal varices: oesophageal varices were recorded according to the general rules of the Japanese Society for Portal Hypertension. Endoscopic signs predictive of oesophageal varice bleeding comprised moderate or large (F2 or F3) blue varices with marked red signs (RC2 or RC3) on their surface.
Prevalence of the target condition: 79% (22/28 participants).
Flow and timing 1 participant was not included in the analysis due to uninterpretable result (the capsule did not reach oesophago‐gastric junction).
Comparative  
Notes Observer variation: no data on observer variation were reported.
Uninterpretable results: data were reported.
Side effects or complications: no side effects or complications were described.
Type of publication: full text.
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Yes    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? Yes    
Did the study enrol only patients with suspected oesophageal varices not until diagnosed? No    
    High Low
DOMAIN 2: Index Test All tests
Were the index test results interpreted without knowledge of the results of the reference standard? Yes    
    Low Low
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? Yes    
Were the reference standard results interpreted without knowledge of the results of the index tests? Unclear    
    Low Low
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard? Yes    
Did all patients receive the same reference standard? Yes    
Were all patients included in the analysis? No    
    High