Laparoendoscopic Rendez Vous Versus Standard Two Stage Approach for the Management of Cholelithiasis/Choledocholithiasis

• postoperative hospital stay [ Time Frame: from onset of intervention to discharge ] [ Designated as safety issue: No ]
  

• success rate of CBD clearance [ Time Frame: during ERCP ] [ Designated as safety issue: Yes ]
  
• failure rate of selective CBD cannulation [ Time Frame: during ERCP ] [ Designated as safety issue: Yes ]
  
• incidence of multiple endoscopic procedures [ Time Frame: within 30 days ] [ Designated as safety issue: Yes ]
  
• incidence of hyperamylasemia [ Time Frame: within 48 hours post-ERCP ] [ Designated as safety issue: Yes ]
  
• incidence of severe pancreatitis (APACHE II score >6) [ Time Frame: within 48 hours post-ERCP ] [ Designated as safety issue: Yes ]
  
• total hospital stay [ Time Frame: from admission to discharge ] [ Designated as safety issue: No ]
  
• complications other but pancreatitis [ Time Frame: within 30 days ] [ Designated as safety issue: Yes ]
  
• death [ Time Frame: within 30 days ] [ Designated as safety issue: Yes ]
  

The ideal management of concomitant cholelithiasis and choledocholithiasis is not known yet. There are several options, including one-stage or two-stage approaches. The most commonly used practice is the two-stage management which consists of preoperative ERCP, sphincterotomy and CBD clearance followed by laparoscopic cholecystectomy. However, with this approach, a number of patients will be submitted to an unnecessary ERCP while some others will develop complications, mainly pancreatitis due to inadvertent pancreatic duct cannulation. Laparo-endoscopic rendez-vous methods have been described in order to obtain selective CBD cannulation and omit the risk of post-ERCP pancreatitis. In this procedure, during laparoscopic cholecystectomy, a wire is inserted through the cystic duct into the common bile duct, advanced into the duodenum where is found endoscopically, gripped with a snare and retrieved through the mouth. The a sphincterotome is inserted over the wire and elective CBD cannulation is obtained to be followed by sphincterotomy and CBD clearance intraoperatively. The method has been described by several authors in small to moderate case series, its safety has been proven and it appears that reduces both the length of hospital stay and the incidence of post-ERCP pancreatitis.However, it has not been popularized and has never been tested over the standard two-stage management. In our hospital, the standard approach for cholelithiasis and choledocholithiasis has been, as well, the two-stage (preop ERCP and sphincterotomy followed by laparoscopic cholecystectomy)approach. We initially assessed the feasibility and safety of the laparo-endoscopic rendez vous with a pilot study and now we intend to compare the two methods in a prospective randomized trial.