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. 2019 Jun 20;2019(6):CD012673. doi: 10.1002/14651858.CD012673.pub2

Lay 1997.

Methods Single‐centre, open randomised clinical trial
Participants Included participants: cirrhosis and oesophageal varices at high risk of bleeding but no previous history of upper gastrointestinal bleeding (n = 126) (Table 4)
Age (mean ± standard deviation):

  • banding 56.0 ± 11.0 years

  • no intervention 55.0 ± 10.0 years


Proportion of men:

  • banding 80.6%

  • no intervention 79.7%


Aetiology of cirrhosis (banding; no intervention):

  • alcohol 19.4%; 17.2%

  • chronic viral hepatitis 75.8%; 76.6%


Child‐Pugh score (A/B/C):

  • banding 17/22/23

  • no intervention 16/23/25


Presence of ascites:

  • banding 33 (53%)

  • no intervention 32 (50%)
Interventions Intervention comparison:
Band ligation (n = 62) (Table 5)

  • Participants who bled during follow‐up underwent endoscopic sclerotherapy


No intervention (n = 64)

  • Participants who bled during follow‐up underwent endoscopic sclerotherapy


Cointervention: sucralfate given routinely to participants in the band ligation group
Outcomes Outomces included in the meta‐analyses

  • Mortality

  • Upper gastrointestinal bleeding

  • Variceal bleeding

  • Serious adverse event
Inclusion period January 1993 to December 1995
Country Taiwan
Duration of follow‐up Mean ± SD (days):

  • banding 370 ± 120

  • no intervention 380 ± 130
Notes Publication status: full paper

  • The two groups were well‐matched with regard to age, sex, and the severity of their liver disease


For‐profit funding: not described
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described
Allocation concealment (selection bias) Unclear risk Sealed‐envelope method. The text does not clarify if the envelopes were serially numbered or opaque.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open randomised clinical trial without blinding
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Open randomised clinical trial without blinding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk There are no missing outcome data and all participants are included in the analyses.
Selective reporting (reporting bias) Low risk Clinically relevant outcomes are defined and reported. We did not have access to the trial protocol.
Other bias Unclear risk Sucralfate given routinely to participants in the band ligation group
Overall bias assessment (mortality) High risk High risk of bias
Overall bias assessment (non‐mortality outcomes) High risk High risk of bias