Methods | Multi‐centre, RCT. Enrolment period: unclear. Endoscopist(s): unclear, but likely multiple endoscopists in multiple centres. | |
Participants | Country: Italy. 88 PEP high‐risk patients (no definition provided for high risk patients). | |
Interventions | 1. Guidewire‐assisted cannulation: a new guidewire with a loop in the tip. No information provided regarding cannulation device. No information on technique. Unclear who advanced the guidewire. 2. Contrast‐assisted cannulation: no information provided regarding the cannulation device or technique. |
|
Outcomes | PEP; post‐ERCP 24 h serum amylase; number of CBD cannulation attempts; technical success (successful cannulation of the CBD). | |
Notes | 1. Defined PEP according to the consensus definition (Cotton 1991). 2. Did not grade the severity of PEP or report outcome data regarding severity of PEP in abstract. 3. "Cross‐over" technique: Cannulation attempt was composed of two phases: phase one consisted of 5 minutes attempts or a maximum of five attempts of main PD cannulation or three attempts of main PD opacification if group 2. If phase 1 failed, would proceed to phase 2 which consisted of 5 minutes or a maximum of five main PD cannulation attempts with the wire. If there was no CBD cannulation after phase 2, "technical cannulation failure" was declared. The endoscopist may either stop the ERCP or use precut to obtain CBD access or continue the CBD cannulation attempt with the wire. 4. Precut was permitted. 5. Did not report on the use of PD stent. 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, no patients were lost to follow‐up. |
Selective reporting (reporting bias) | Low risk | Reported all important outcomes. |
Other bias | Low risk | No other risk of bias. |