Timing of Precut Procedure Does Not Influence Success Rate and Complications of ERCP Procedure. A Prospective Randomized Comparative Study

Abstract

Background: There is scarce information on whether performing the pre-cut procedure early rather than after several cannulation attempts is associated with different success and complication rates.ObjectiveTo compare the success and complication rates of precutting implemented either early or after prolonged attempts by the standard approach. Patients and Methods: Patients were considered for inclusion if biliary access failed after 5 minutes of biliary cannulation attempts or if up to three unintended cannulation of the pancreatic duct occurred. If biliary access was successful within 5 minutes of standard attempts and less than three unintended cannulations of the pancreatic duct occurred,patients were not included in this study. Furthermore, patients with pancreatitis, diverticular papilla, prior gastric surgery, papillary neoplasia,severe comorbidity, coagulopathy or less than 18 years old,were not considered eligible.Included patients were then randomly assigned, in a 1:3 ratio,to group A or group B. Patients randomized to group A (“Early precut”) underwent precut,immediately after the randomization. According to inclusion criteria, no more than 5 minutes of biliary cannulation attempts by standard approach and three cannulations of the pancreatic duct occurred prior to randomization. Patients randomized in group B were submitted to prolonged attempts with standard cannulation for further 20 minutes, without any limitations of pancreatic duct cannulation; if access to the common bile duct was gained within this time, patients were included in the “Standard access sub-group”(B1), otherwise, a pre-cut procedure was carried out and patients included in the “delayed precut” sub-group(B2). Outome measurements Deep biliary cannulation and the incidence of post-ERCP complications. Results: Over the 2-year study period, 1078 therapeutic ERCP procedures were performed. One hundred and forty-six patients (mean age 68.5 years [34-88 years], 67 men and 79 women) met the selection criteria and were randomized into 2 groups (on a 1:3 basis): 36 patients were assigned to group A and 110 to group B. Precut procedure performed in group A allowed deep cannulation of common bile duct in 33 out of 36 patients (92%). In group B, cannulation was successfully achieved in 104 out of 110 patients (95%). Among group B, biliary cannulation was achieved with standard approach in 78 patients, while pre-cutting was performed in 32 patients and deep cannulation was achieved in 26 of them. The overall complication rate was 8% (3/36) in group A and 6% (7/110) in group B. Conclusions: Timing of pre-cutting does not influence success and complication rates of ERCP procedures.