Primary needle-knife fistulotomy versus rescue precut: a systematic review and meta-analysis of outcomes

Background and AimsPost-ERCP pancreatitis (PEP) is encountered especially after difficult and prolonged standard biliary cannulation (SBC). Access sphincterotomy techniques such as needle-knife fistulotomy (NKF) aid in biliary cannulation but carry risks of PEP, bleeding, and perforation. We conducted a systematic review and meta-analysis to assess the safety and success of primary NKF (p-NKF; before attempted cannulation) compared with rescue precut (precut techniques used if SBC failed).MethodsWe searched multiple databases through December 2021 for studies comparing outcomes of p-NKF versus rescue precut. The primary outcome was risk of PEP in both groups, and secondary outcomes were rates of adverse events, rates of successful biliary cannulation, and time required for biliary cannulation.ResultsFive studies, including 2 randomized controlled trials, with 1375 patients were included in the final analysis, with 541 patients in the p-NKF group and 834 in the control group. Patients undergoing NKF had an overall lower risk of PEP (odds ratio [OR], .33; 95% confidence interval [CI], .17-.66; I2 = 0%) and asymptomatic hyperamylasemia (OR, .58; 95% CI, .36-.96; I2 = 0%) compared with control subjects. The pooled rate of PEP with NKF was 1.85% (95% CI, .71-2.98), and the pooled rate of successful initial cannulation was 94.7% (95% CI, 92.7-96.7; I2 = 72%) in the p-NKF group. The time required for biliary cannulation was comparable between the 2 groups (difference in means, –2.48 minutes; 95% CI, –7.70 to 2.74; I2 = 99%). In terms of adverse events, there was no difference between the 2 groups for bleeding (OR, 1.19; 95% CI, .53-2.69; I2 = 0%), cholangitis (OR, .79; 95% CI, .23-2.79; I2 = 0%), or perforation (OR, .90; 95% CI, .17-4.75; I2 = 0%).ConclusionsAlthough our study was limited to data from expert advanced endoscopists, our analysis showed that performing p-NKF compared with rescue access sphincterotomy was associated with a lower risk of PEP, with similar successful biliary cannulation rates, cannulation times, and overall safety profile. Post-ERCP pancreatitis (PEP) is encountered especially after difficult and prolonged standard biliary cannulation (SBC). Access sphincterotomy techniques such as needle-knife fistulotomy (NKF) aid in biliary cannulation but carry risks of PEP, bleeding, and perforation. We conducted a systematic review and meta-analysis to assess the safety and success of primary NKF (p-NKF; before attempted cannulation) compared with rescue precut (precut techniques used if SBC failed). We searched multiple databases through December 2021 for studies comparing outcomes of p-NKF versus rescue precut. The primary outcome was risk of PEP in both groups, and secondary outcomes were rates of adverse events, rates of successful biliary cannulation, and time required for biliary cannulation. Five studies, including 2 randomized controlled trials, with 1375 patients were included in the final analysis, with 541 patients in the p-NKF group and 834 in the control group. Patients undergoing NKF had an overall lower risk of PEP (odds ratio [OR], .33; 95% confidence interval [CI], .17-.66; I2 = 0%) and asymptomatic hyperamylasemia (OR, .58; 95% CI, .36-.96; I2 = 0%) compared with control subjects. The pooled rate of PEP with NKF was 1.85% (95% CI, .71-2.98), and the pooled rate of successful initial cannulation was 94.7% (95% CI, 92.7-96.7; I2 = 72%) in the p-NKF group. The time required for biliary cannulation was comparable between the 2 groups (difference in means, –2.48 minutes; 95% CI, –7.70 to 2.74; I2 = 99%). In terms of adverse events, there was no difference between the 2 groups for bleeding (OR, 1.19; 95% CI, .53-2.69; I2 = 0%), cholangitis (OR, .79; 95% CI, .23-2.79; I2 = 0%), or perforation (OR, .90; 95% CI, .17-4.75; I2 = 0%). Although our study was limited to data from expert advanced endoscopists, our analysis showed that performing p-NKF compared with rescue access sphincterotomy was associated with a lower risk of PEP, with similar successful biliary cannulation rates, cannulation times, and overall safety profile.