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

Study Status: Enrolling by invitation
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Laparoendoscopic Rendez Vous (Intraoperative ERCP) vs Two Stage Approach (Preoperative ERCP Followed by Laparoscopic Cholecystectomy) for the Management of Cholelithiasis/Choledo

Brief Summary: The purpose of the study is to assess whether combined intraoperative ERCP and CBD clearance with laparo-endoscopic rendez-vous during laparoscopic cholecystectomy (one stage approach) is or not superior to the standard practice of preoperative ERCP, sphincterotomy and CBD clearance followed by laparoscopic cholecystectomy (two stage approach) in patients with combined cholelithiasis and choledocholithiasis.

Detailed Summary: 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.
Sponsor: University of Thessaly

Current Primary Outcome: postoperative hospital stay [ Time Frame: from onset of intervention to discharge ]

Original Primary Outcome: postoperative hospital stay (from onset of treatment to discharge)

Current Secondary Outcome:

  • success rate of CBD clearance [ Time Frame: during ERCP ]
  • failure rate of selective CBD cannulation [ Time Frame: during ERCP ]
  • incidence of multiple endoscopic procedures [ Time Frame: within 30 days ]
  • incidence of hyperamylasemia [ Time Frame: within 48 hours post-ERCP ]
  • incidence of severe pancreatitis (APACHE II score >6) [ Time Frame: within 48 hours post-ERCP ]
  • total hospital stay [ Time Frame: from admission to discharge ]
  • complications other but pancreatitis [ Time Frame: within 30 days ]
  • death [ Time Frame: within 30 days ]


Original Secondary Outcome:

  • success rate of CBD clearance
  • failure rate of selective CBD cannulation
  • incidence of multiple endoscopic procedures
  • incidence of hyperamylasemia
  • incidence of severe pancreatitis (APACHE II score >6)
  • total hospital stay
  • 30day morbidity
  • 30day mortality


Information By: University of Thessaly

Dates:
Date Received: December 26, 2006
Date Started: September 2006
Date Completion: December 2010
Last Updated: January 13, 2010
Last Verified: June 2008