BACKGROUND: Among the procedure-related factors associated with post-ERCP pancreatitis, selective cannulation of the common bile duct by insertion of a guidewire may be associated with fewer complications than conventional methods of cannulation with contrast injection to access the bile duct. However, the results of studies regarding the usefulness of wire-guided cannulation (WGC) are conflicting. OBJECTIVE: This prospective randomized trial was designed to determine whether WGC reduces the rate of post-ERCP pancreatitis. DESIGN: A prospective randomized controlled trial. SETTING:Tertiary-care academic medical center. PATIENTS: A total of 300 consecutive patients with native papilla and pancreaticobiliary disease who were candidates for therapeutic ERCP were randomized from June 2006 to May 2007. INTERVENTIONS:WGC without contrast injection or conventional cannulation with contrast injection. MAIN OUTCOME MEASUREMENTS: Post-ERCP pancreatitis, risk factors, and procedure-related complications were evaluated prospectively. RESULTS: A total of 3 patients (2%) in the WGC group and 17 patients (11.3%) in the conventional group had post-ERCP pancreatitis (P = .001). Among the cases of acute pancreatitis in the WGCgroup, 2 patients with suspected sphincter of Oddi dysfunction (SOD) and unintentional main pancreatic duct (PD) guidewire cannulation showed post-ERCP pancreatitis despite the use of WGC. In multivariate analysis, WGC was a protective factor (odds ratio 0.1; 95% CI, 0.024-0.490, P = .004), whereas female sex and SOD were risk factors for post-ERCP pancreatitis. LIMITATION: Our study population was a low-risk cohort. CONCLUSIONS:WGC is associated with a lower rate of post-ERCP pancreatitis. However, WGC may not prevent post-ERCP pancreatitis in patients with suspected SOD and unintentional PD guidewire cannulation.
RCT Entities:
BACKGROUND: Among the procedure-related factors associated with post-ERCP pancreatitis, selective cannulation of the common bile duct by insertion of a guidewire may be associated with fewer complications than conventional methods of cannulation with contrast injection to access the bile duct. However, the results of studies regarding the usefulness of wire-guided cannulation (WGC) are conflicting. OBJECTIVE: This prospective randomized trial was designed to determine whether WGC reduces the rate of post-ERCP pancreatitis. DESIGN: A prospective randomized controlled trial. SETTING: Tertiary-care academic medical center. PATIENTS: A total of 300 consecutive patients with native papilla and pancreaticobiliary disease who were candidates for therapeutic ERCP were randomized from June 2006 to May 2007. INTERVENTIONS: WGC without contrast injection or conventional cannulation with contrast injection. MAIN OUTCOME MEASUREMENTS: Post-ERCP pancreatitis, risk factors, and procedure-related complications were evaluated prospectively. RESULTS: A total of 3 patients (2%) in the WGC group and 17 patients (11.3%) in the conventional group had post-ERCP pancreatitis (P = .001). Among the cases of acute pancreatitis in the WGC group, 2 patients with suspected sphincter of Oddi dysfunction (SOD) and unintentional main pancreatic duct (PD) guidewire cannulation showed post-ERCP pancreatitis despite the use of WGC. In multivariate analysis, WGC was a protective factor (odds ratio 0.1; 95% CI, 0.024-0.490, P = .004), whereas female sex and SOD were risk factors for post-ERCP pancreatitis. LIMITATION: Our study population was a low-risk cohort. CONCLUSIONS: WGC is associated with a lower rate of post-ERCP pancreatitis. However, WGC may not prevent post-ERCP pancreatitis in patients with suspected SOD and unintentional PD guidewire cannulation.
Authors: Hanna Vihervaara; Juha M Grönroos; Mari Koivisto; Risto Gullichsen; Paulina Salminen Journal: Surg Endosc Date: 2012-12-19 Impact factor: 4.584