A multicenter, prospective, randomized study of selective bile duct cannulation performed by multiple endoscopists: the BIDMEN study

Abstract

Background: Wire-guided cannulation (WGC) with a sphincterotome for selective bile duct cannulation (SBDC) has been reported to have a higher success rate and lower incidence of post-ERCP pancreatitis (PEP) than conventional methods in some randomized controlled trials (RCTs) that were both single-center and limited to only a few endoscopists.Objective: To estimate the difference in SBDC according to the method and catheter used in a multicenter and multi-endoscopist study. Design:A prospective multicenter RCT with a 2-by-2 factorial design. Setting: Fifteen referral endoscopy units.Patients: In total, 400 consecutive patients with naïve papilla who were candidates for ERCP were enrolled and randomized.Interventions: Patients were assigned to 4 groups according to combined catheter (sphincterotome (S) or catheter (C)) and method (with/without guidewire (GW)). Main Outcome Measurements:Success rate of SBDC in 10 min, time for SBDC, fluoroscopic time and incidence of complications. Results:There was no significant difference in SBDC success rate between with-and without-GW, between C and S, or between the 4 groups (C+GW, C, S+GW, and S). WGC had a tendency to significantly shorten cannulation and fluoroscopic times only in approximately 70% of patients in this study in whom SBDC was achieved in 10 min or less (P = 0.036 and 0.00004, respectively). All 4 groups resulted in similar outcomes in PEP (4%, 5.9%, 2%, and 2.1%, respectively).Limitations: Non-double-blinded study. Kawakami-4 4Conclusions: WGC appears to significantly shorten cannulation and fluoroscopic times.However, neither the method nor type of catheter used resulted in significant differences in either SBDC success rate or incidence of PEP in this RCT. Kawakami-5 5 Keywords:Wire-guided cannulation; Selective bile duct cannulation; Post-ERCP pancreatitis; Randomized controlled trial; Cannulation time; Fluoroscopic time; Radiation exposure time Kawakami-6 6 INTRODUCTIONBiliary cannulation is the most basic procedure for performing biliary interventions; however, no standard has been established to date. The success rates are considered to be related to 3 factors: the kind of catheter, cannulation method, and the skill of the endoscopist. The complication rates are also related to 3 factors: patient, procedure factors, and operator expertise. Cannulations using a sphincterotome with wire-guided cannulation (WGC) instead of the conventional catheter, with contrast medium injection, are gradually performed in many countries. These new methods were reported to be superior to conventional techniques in terms of both success rate and the incidence of post-ERCP pancreatitis (PEP) in some randomized studies [1][2][3][4][5]. However, those studies were performed by either a single or, at most, two skilled endoscopists in a single center [1,2,4,5]. Thus, these data cannot be generalized more widely.In these previous studies, 5° backward-oblique angle therapeutic duodenoscopes (BOAD) were used. In Japan, standard duodenoscopes have traditionally been 15° BOAD. Thu...

No Benefit of Endoscopic Sphincterotomy Before Biliary Placement of Self-Expandable Metal Stents for Unresectable Pancreatic Cancer

“…In prospective multicenter clinical studies in Japan, the rate of post-ERCP pancreatitis in high-risk and unselected subjects has been reported to be 11.3% and 3.5%, respectively. 21,22 These rates are similar to those reported in other ethnic groups. 23,24 In addition, one of the major causes of post-metallic stent placement pancreatitis is the occlusion of the pancreatic orifice.…”

Effectiveness of the J-Tip Guidewire for Selective Biliary Cannulation Compared to Conventional Guidewires (The JANGLE Study)

“…Several randomized studies, systematic reviews, and meta-analyses have reported that WGC is superior to conventional techniques in terms of both the success rate and the incidence of PEP [1][2][3][4][5][6][7][8]. On the other hand, two RCTs from Japan showed no statistically significant difference between the two techniques [12,13].…”

Difficult Biliary Access

“…Although wire-guided cannulation was found to significantly shorten cannulation and fluoroscopy times, it did not decrease the incidence of PEP. 9 Another prospective comparative-intervention single-center study of 1249 patients found no significant difference in the rate or severity of PEP between the guidewire and contrast-assisted groups. In fact, there was actually a trend toward increased risk of pancreatitis in the guidewire-assisted group, but the risk of severe pancreatitis occurred more often in the contrast injection group.…”