RESUMEN
BACKGROUND: Wire-guided cannulation (WGC) with a sphincterotome (S) 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 multiendoscopist study. DESIGN: A prospective, multicenter RCT with a 2 × 2 factorial design. SETTING: Fifteen referral endoscopy units. PATIENTS: In total, 400 consecutive patients with naive papillae who were candidates for ERCP were enrolled and randomized. INTERVENTIONS: Patients were assigned to 4 groups according to combined catheter (S or catheter [C]) and method (with/without guidewire [GW]). MAIN OUTCOME MEASUREMENTS: Success rate of SBDC performed in 10 minutes, SBDC time, fluoroscopy time, and incidence of complications. RESULTS: There was no significant difference in the SBDC success rate between the groups with and without GW, between C and S, or among the 4 groups (C+GW, C, S+GW, S). WGC had a tendency to significantly shorten cannulation and fluoroscopy times only in approximately 70% of patients in this study in whom SBDC was achieved in 10 minutes or less (P = .036 and .00004, respectively). All 4 groups resulted in similar outcomes in PEP (4%, 5.9%, 2%, and 2.1%, respectively). LIMITATIONS: Non-double-blind study. CONCLUSIONS: WGC appears to significantly shorten cannulation and fluoroscopy 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. ( CLINICAL TRIAL REGISTRATION NUMBER: UMIN000002572.).
Asunto(s)
Cateterismo/métodos , Esfinterotomía Endoscópica/métodos , Adulto , Anciano , Anciano de 80 o más Años , Conductos Biliares , Enfermedades de las Vías Biliares/diagnóstico , Cateterismo/efectos adversos , Cateterismo/instrumentación , Colangiopancreatografia Retrógrada Endoscópica , Competencia Clínica , Femenino , Humanos , Análisis de Intención de Tratar , Modelos Logísticos , Masculino , Persona de Mediana Edad , Enfermedades Pancreáticas/diagnóstico , Esfinterotomía Endoscópica/efectos adversos , Esfinterotomía Endoscópica/instrumentación , Factores de TiempoRESUMEN
BACKGROUND & AIMS: Pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) is the most common and potentially serious complication of ERCP. The frequency of post-ERCP pancreatitis generally is reported to be between 1% and 9%. One cause of pancreatitis is retention of pancreatic juice resulting from papilledema after the procedure. We conducted a randomized controlled multicenter study to evaluate whether placement of a temporary pancreatic stent designed for spontaneous dislodgement prevents post-ERCP pancreatitis. METHODS: The subjects were 201 consecutive patients who underwent ERCP. The patients were randomized into the stent placement group (S group = 98) or the nonstent placement group (nS group = 103). The stent used was 5F in diameter, 3 cm in length, straight, and unflanged inside. RESULTS: Stents were placed successfully in 96% of the S group, and spontaneous stent dislodgment was recognized in 95.7% of those. The mean duration to dislodgment was 2 days, and there were no severe complications. The overall frequency of post-ERCP pancreatitis was 8.5%. The frequency of post-ERCP pancreatitis in the S and nS groups was 3.2% and 13.6%, respectively, showing a significantly lower frequency in the S group (P = .019). The mean increase in amylase level in the pancreatitis patients was significantly higher in the nS group (P = .014). CONCLUSIONS: The randomized controlled multicenter trial showed that placement of a pancreatic spontaneous dislodgment stent significantly reduces post-ERCP pancreatitis.
