Study Finds Primary Precut Sphincterotomy Better Than Early Precut for Preventing Post-ERCP Pancreatitis

A randomized controlled trial was performed to assess the safety and efficacy of primary precut sphincterotomy to access the bile duct during endoscopic retrograde cholangiopancreatography.

Primary precut sphincterotomy performed by an experienced endoscopist was found to be associated with a lower risk of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) compared with early precut sphincterotomy, according to the results of a study published in Gastrointestinal Endoscopy.

The study was conducted at a tertiary care center in India between 2017 and 2018, and included 303 patients (mean age [±SD], 47.5±14.5 years) who underwent ERCP performed by an expert endoscopist with approximately 25 years of experience in the procedure (ie, >1000 ERCPs performed per year).

Patients were randomly assigned to either a very early precut group (n=152) or a primary precut group (n=151). Very early precut was performed after 2 failed wire-guided sphincterotome cannulation attempts, and primary precut consisted of a direct needle-knife sphincterotomy. The primary outcome of the study was the comparative incidence of post-ERCP pancreatitis among the 2 arms.

The indications for ERCP in the overall cohort were choledocholithiasis (n=172), malignant biliary stricture (n=80), benign biliary stricture (n=29), bile leak (n=13), choledochal cyst (n=8), and Mirizzi syndrome (n=1). No statistically significant differences were noted between the 2 groups for these indications.

Compared with patients who underwent very early precut, a significantly lower proportion of patients assigned to primary precut developed pancreatitis following ERCP (5.2% vs 0.67%, respectively; P =.04) or asymptomatic hyperamylasemia (12.5% vs 2.6%; P =.01). Patients who underwent primary precut were found to have a lower bile duct cannulation time (13.8±2.2 vs 7.2±1.7 minutes; P =.001).

Time until deep common bile duct cannulation was significantly less with primary vs very early precut (13.8±2.2 vs 7.2±1.7 minutes, respectively; P =.001). Overall cannulation success rates were similar among both groups (98.6% vs 98%, respectively; P =1.0).

This study is limited by its enrollment of patients from a single center in India. Additionally, the study investigators did not use post-ERCP pancreatitis prophylaxis consisting of pancreatic stent placement and rectal indomethacin or diclofenac, measures that are recommended for patients at high risk for pancreatitis after the procedure.

The researchers emphasized that the interpretation of these results should be met with the knowledge “that precut sphincterotomy is safe and effective only in an expert’s hands.”

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Maharshi S, Sharma SS. Early precut versus primary precut sphincterotomy to reduce post-ERCP pancreatitis: randomized controlled trial (with videos) Concise and informative title- primary precut to prevent post ERCP pancreatitis [published online June 29, 2020]. Gastrointest Endosc. doi:10.1016/j.gie.2020.06.064