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临床试验/NCT00416234
NCT00416234Unknown不适用

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

University of Thessaly2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2006年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
2
主要终点
postoperative hospital stay

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients must be able to give informed consent preoperatively
  • ASA I-III
  • patients at high risk to have CBD stones (jaundice, cholangitis, grossly deranged LFTs, CBD stones found on US or MRCP)

排除标准

  • patients not fit for surgery (ASA IV)
  • previous ERCP and sphincterotomy
  • previous upper abdominal surgery
  • pregnancy at time of surgery

结局指标

主要结局

postoperative hospital stay

时间窗: from onset of intervention to discharge

次要结局

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

研究者

申办方类型
Other

研究点 (2)

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