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. 2012 Dec 12;2012(12):CD009662. doi: 10.1002/14651858.CD009662.pub2
Methods Single centre, RCT. Enrolment period: unclear. Endoscopist(s): unclear.
Participants Country: Italy. 200 patients with biliary disease submitted to ERCP.
Interventions 1. Guidewire‐assisted cannulation: a soft tipped tracer guidewire through a sphincterotome. The tip of the sphincterotome was inserted into the papilla, followed by advancement of the guidewire and opacification. Unclear who advanced the guidewire.
2. Contrast‐assisted cannulation: standard method of cannulation through a sphincterotome.
Outcomes PEP (reported according to type of duct cannulated or failed cannulation).
Notes 1. Did not define PEP in abstract.
2. Did not grade the severity of PEP or report outcome data regarding severity of PEP in abstract.
3. Did not report on the use of technique 'cross‐over'.
4. Did not report on the use of precut.
5. Did not report on the use of PD stent.
6. PEP incidence according to the type of duct cannulated in the table is unclear. Successful cannulation based on number of failed cannulation: 98 vs 96. Unclear whether PD cannulation was intentional or inadvertent.
Unsuccessful attempts to contact authors for additional data.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Conference proceeding, no information was provided.
Allocation concealment (selection bias) Unclear risk Conference proceeding, no information was provided.
Blinding of participants and personnel (performance bias) All outcomes High risk Conference proceeding, no information was provided. Endoscopists could not be blinded.
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Conference proceeding, no information was provided.
Incomplete outcome data (attrition bias) All outcomes Low risk PEP reported in ITT sample. All patients were accounted for with no loss to follow‐up.
Selective reporting (reporting bias) Low risk Reported all important outcomes. Information pertaining to successful cannulation and inadvertent PD cannulation presented in the table is unclear
Other bias Low risk No other risk of bias.