Primary Needle-Knife Fistulotomy Versus Conventional Cannulation Method in a High-Risk Cohort of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis

Abstract

OBJECTIVES: Successful biliary cannulation is a prerequisite and important component of endoscopic retrograde cholangiopancreatography, but conventional cannulation methods (CCMs) have a postendoscopic retrograde cholangiopancreatography pancreatitis (PEP) rate of 14.1% in patients at high risk for PEP. The aim of this study was to evaluate the effectiveness and safety of needle-knife fistulotomy (NKF), compared with a CCM, when used for primary biliary access in patients at high risk for developing PEP. METHODS: A total of 207 patients with one or more risk factors for PEP were prospectively enrolled. The patients were randomly allocated to one of 2 groups according to the primary biliary cannulation technique (NKF or CCM). We compared biliary cannulation success rates, cannulation and procedure times, and the incidence of adverse events, including PEP, between the groups. RESULTS: The mean number of PEP risk factors was similar between the groups (NKF, 2.2 ± 1.0; CCM, 2.2 ± 0.9). PEP occurred in 8 patients in the CCM group and in no patients in the NKF group (9.2% vs 0%, P < 0.001). The rates of other adverse events did not differ between the groups. The biliary cannulation success rate was high in the NKF group, but relatively low in the CCM group, possibly because of the stringent failure criteria aimed at reducing PEP. However, the mean cannulation and total procedural times were longer in the NKF group than in the CCM group. DISCUSSION: NKF is an effective and safe procedure to gain primary biliary access in patients at high risk for developing PEP. ClinicalTrials.gov, NCT02916199.

Fistulotomy versus standard cannulation as the primary technique for all patients undergoing ERCP with a native papilla: A protocol for a single centre randomized controlled trial

“…In our pilot study, NNF was shown to be at least as safe as the traditional access technique with a sphincterotome. A recent study by Jang et al showed that NNF was an effective and safe procedure to gain primary biliary access with a lower PEP rate (25). However, this study only included patients at high risk for PEP and prophylactic NSAIDs were not used in this study.…”

Response

“…8 Primary fistulotomy with a needle-knife is also considered safe and prevents PEP. [9][10] In our study, we compared primary precut with very early precut and demonstrated that primary precut in expert hands results in a low risk of PEP, with an overall similar cannulation success rate. 2 There is a widespread belief, even among experts, that precut is a risky technique and is associated with post-ERCP adverse events.…”

Comparison of the Diagnostic Performance of Novel Slim Biopsy Forceps with Conventional Biopsy Forceps for Biliary Stricture: A Multicenter Retrospective Study

“…A rescue infundibulotomy was attempted if the cannulation was difficult. A primary infundibulotomy with a needle knife was attempted, without any attempted cannulation, if the patient had a prominent ampulla of Vater that was expected to be difficult to cannulate [17]. When a guidewire was inadvertently inserted into the pancreatic duct and failed to cannulate the EHD, the double guidewire method was occasionally used.…”