Scolaris Content Display Scolaris Content Display

Study flow diagram
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Figure 1

Study flow diagram

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Trial Sequential Analysis of no clearance of jaundice by six months post Kasai portoenterostomy
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Figure 4

Trial Sequential Analysis of no clearance of jaundice by six months post Kasai portoenterostomy

Trial Sequentil Analysis for all‐cause mortality or liver transplantation at two years
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Figure 5

Trial Sequentil Analysis for all‐cause mortality or liver transplantation at two years

Trial Sequential Analysis of no clearance of jaundice at six months in the subgroup of infants who were less than 70 days old at the time of Kasai portoenterostomy
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Figure 6

Trial Sequential Analysis of no clearance of jaundice at six months in the subgroup of infants who were less than 70 days old at the time of Kasai portoenterostomy

Comparison 1 Primary outcomes, Outcome 1 All‐cause mortality.
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Analysis 1.1

Comparison 1 Primary outcomes, Outcome 1 All‐cause mortality.

Comparison 1 Primary outcomes, Outcome 2 Serious adverse event.
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Analysis 1.2

Comparison 1 Primary outcomes, Outcome 2 Serious adverse event.

Comparison 2 Secondary outcomes, Outcome 1 Infants who did not clear jaundice at six months.
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Analysis 2.1

Comparison 2 Secondary outcomes, Outcome 1 Infants who did not clear jaundice at six months.

Comparison 2 Secondary outcomes, Outcome 2 All‐cause mortality or liver transplantation at two years.
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Analysis 2.2

Comparison 2 Secondary outcomes, Outcome 2 All‐cause mortality or liver transplantation at two years.

Comparison 2 Secondary outcomes, Outcome 4 Subgroup analysis of infants operated on at age of < 70 days who did not clear their jaundice by six months post KPE.
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Analysis 2.4

Comparison 2 Secondary outcomes, Outcome 4 Subgroup analysis of infants operated on at age of < 70 days who did not clear their jaundice by six months post KPE.

Comparison 2 Secondary outcomes, Outcome 5 Subgroup analysis of infants operated on at age of > 69 days who did not clear their jaundice by six months post KPE.
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Analysis 2.5

Comparison 2 Secondary outcomes, Outcome 5 Subgroup analysis of infants operated on at age of > 69 days who did not clear their jaundice by six months post KPE.

Glucocorticosteroids for infants with biliary atresia following Kasai portoenterostomy

Patient or population: infants with biliary atresia

Settings: hospitals

Intervention: glucocorticosteroids

Comparison: placebo

Outcomes

Illustrative comparative risks* (95% CI)

Risk Ratio
(95% CI)

Number (no) of infants
(no of RCTs)

Certainty of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Placebo

Glucocorticosteroids

All‐cause mortality

six months after Kasai portoenterostomy

19 per 1000

19 per 1000
(3 to 131)

1.00

(0.14 to 6.90)

104 placebo

107 treatment
(2 RCTs, Bezerra 2014; Davenport 2007)

⊕⊕⊝⊝
low1

Serious adverse event,

two years follow‐up

800 per 1000

814 per 1000
(708 to 977)

1.02

(0.87 to 1.20)

70 placebo

70 treatment
(1 RCT, Bezerra 2014)

⊕⊕⊝⊝
low2

A significantly higher proportion of the treatment group had their first serious adverse event in the first 30 days after their Kasai portoenterostomy.

Health‐related quality of life

There are no data for this outcome in the included trials.

Infants who did not clear jaundice at six months

514 per 1000

452 per 1000
(303 to 529)

0.89

(0.67 to 1.17)

107 placebo

104 treatment
(2 RCTs, Bezerra 2014; Davenport 2007)

⊕⊕⊝⊝
low1

The required information size for significance for the Trial Sequential Analysis was 540. The number of infants included in this meta‐analysis was 211, corresponding to 39.1% of the required information size.

All‐cause mortality or liver transplantation at two years

402 per 1000

404 per 1000
(291 to 562)

1.00 (0.72 to 1.39)

107 placebo

104 treatment
(2 RCTs, Bezerra 2014; Davenport 2007)

⊕⊕⊝⊝
low1

The required information size for significance for the Trial Sequential Analysis was 1774. The number of infants included in this meta‐analysis was 211, corresponding to 11.9% of the required information size.

Subgroup analysis of infants operated on at less than 70 days of age who did not clear their jaundice by six months after Kasai portoenterostomy

516 per 1000

381 per 1000
(210 to 423)

0.75 (0.55 to 1.11)

64 placebo

63 treatment
(2 RCTs, Bezerra 2014; Davenport 2007)

⊕⊕⊝⊝
low1

The required information size for significance for the Trial Sequential Analysis was 538. The number of infants included in this meta‐analysis was 127, corresponding to 23.6% of the required information size.

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval. RCT: randomised clinical trial.

GRADE Working Group grades of evidence

  • High certainty: this research provides a very good indication of the likely effect; the likelihood that the effect will be substantially different is low.

  • Moderate certainty: this research provides a good indication of the likely effect; the likelihood that the effect will be substantially different is moderate.

  • Low certainty: this research provides some indication of the likely effect; however, the likelihood that it will be substantially different is high.

  • Very low certainty: this research does not provide a reliable indication of the likely effect; the likelihood that the effect will be substantially different is very high.

1 Downgraded two levels due to imprecision of the evidence: Trial Sequential Analysis determined that the sample size was insufficient to detect a difference between the two groups.

2 Downgraded one level due to imprecision of the evidence and another level due to inconsistency of the evidence: there was heterogeneity between the trials and there were inconsistent assessments of what constituted a significant adverse event. Trial Sequential Analysis determined that the sample size was insufficient to detect a difference between the two groups.

Figures and Tables -
Comparison 1. Primary outcomes

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 All‐cause mortality Show forest plot

2

211

Risk Ratio (M‐H, Random, 95% CI)

1.0 [0.14, 6.90]

2 Serious adverse event Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

Figures and Tables -
Comparison 1. Primary outcomes
Comparison 2. Secondary outcomes

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Infants who did not clear jaundice at six months Show forest plot

2

211

Risk Ratio (M‐H, Random, 95% CI)

0.89 [0.67, 1.17]

2 All‐cause mortality or liver transplantation at two years Show forest plot

2

211

Risk Ratio (M‐H, Fixed, 95% CI)

1.00 [0.72, 1.39]

3 Non‐serious adverse events

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

4 Subgroup analysis of infants operated on at age of < 70 days who did not clear their jaundice by six months post KPE Show forest plot

2

127

Risk Ratio (M‐H, Random, 95% CI)

0.77 [0.46, 1.29]

5 Subgroup analysis of infants operated on at age of > 69 days who did not clear their jaundice by six months post KPE Show forest plot

2

84

Risk Ratio (M‐H, Random, 95% CI)

1.09 [0.74, 1.62]

Figures and Tables -
Comparison 2. Secondary outcomes