Table 1.
GRADE evidence profile for impact of surgical alternatives for pancreatic cancer from systematic review and meta-analysis of randomised controlled trials in inpatient hospitals of pylorus preserving versus standard Whipple pancreaticoduodenectomy for pancreatic or periampullary cancer by Karanicolas et al19
| No of studies (No of participants) | Quality assessment | Summary of findings | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Study limitations* | Consistency | Directness | Precision | Publication bias | Relative effect† (95% CI) | Best estimate of Whipple group risk | Absolute effect (95% CI) | Quality | ||
| Five year mortality: | ||||||||||
| 3 (229) | Serious limitations (−1) | No important inconsistency | Direct | No important imprecision | Unlikely | 0.98 (0.87 to 1.11) | 82.5% | 20 less/1000; 120 less to 80 more | +++, moderate | |
| In-hospital mortality: | ||||||||||
| 6 (490) | Serious limitations (−1) | No important inconsistency | Direct | Imprecision (−1)‡ | Unlikely | 0.40 (0.14 to 1.13) | 4.9% | 20 less/1000; (50 less to 10 more) | ++, low | |
| Blood transfusions (units): | ||||||||||
| 5 (320) | Serious limitations (−1) | No important inconsistency | Direct | No important imprecision | Unlikely | — | 2.45 units | −0.66 (−1.06 to −0.25); favours pylorus preservation | +++, moderate | |
| Biliary leaks: | ||||||||||
| 3 (268) | Serious limitations (−1) | No important inconsistency | Direct | Imprecision (−1)‡ | Unlikely | 4.77 (0.23 to 97.96) | 0 | 20 more/1000 20 less to 50 more | ++, low | |
| Hospital stay (days): | ||||||||||
| 5 (446) | Serious limitations (−1) | No important inconsistency | Direct | Imprecision (−1)‡ | Unlikely | — | 19.17 days | −1.45 (−3.28 to 0.38); favours pylorus preservation | ++, low | |
| Delayed gastric emptying: | ||||||||||
| 5 (442) | Serious limitations (−1) | Unexplained heterogeneity (−1)§ | Direct | Imprecision (−1)‡ | Unlikely | 1.52 (0.74 to 3.14) | 25.5% | 110 more/1000; 80 less to 290 more | +, very low | |
*Unclear allocation concealment in all studies, patients blinded in only one study, outcome assessors not blinded in any study, >20% loss to follow-up in three studies, not analysed using intention to treat in one study.
†Relative risks (95% confidence intervals) are based on random effect models.
‡Confidence interval includes possible benefit from both surgical approaches.
§I2=72.6%, P=0.006.