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. |
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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. |
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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). |
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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. |
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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 |