Clinical Trial: Comparison of LCBDE vs ERCP + LC for Choledocholithiasis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Long Term Complications Comparison of Laparoscopic Common Bile Duct Exploration and Cholecystectomy Versus Sequential ERCP Followed by Laparoscopic Cholecystectomy for Choledoc

Brief Summary: Protection of Oddi's sphincter remains a huge argument especially in the long term complications like common bile duct stone recurrence or cholangitis after ERCP, which determined to destroy the sphincter of Oddi. The purpose of this study is to compare the long-term outcomes of ERCP sequential LC versus LCBDE for choledocholithiasis.

Detailed Summary:

Cholelithiasis, a common etiology factor responsible for abdominal pain, is highly prevalent worldwide. According to data from general investigation, the morbidity of cholelithiasis differs from 2.36% to 42% in different areas, and about 5% to 29% (average 18%) of all cholelithiasis cases have both gallbladder stone and common bile duct stone. In the population with age above 70 years old, 30% of which suffers from gallbladder stone in China. A causal link between the development of gallbladder stone and common bile duct stone is that 10% to 15% of gallstone patients have high potential to develop secondary common bile duct stone. In 1987, the laparoscopic cholecystectomy (LC) came into being as a revolutionary surgical method. With minimally invasive effect and high safety, LC was soon accepted as a 'Golden standard' for the treatment of gallbladder stone. Endoscopic sphincterotomy (EST) was firstly reported by Kawai and Classen in 1970. As of now, the combination of EST with other endoscopic techniques, such as basket extraction, balloon dilation and lithotripsy, have significantly improved the stone removal rate from 85% up to 90%, and ERCP has been considered as the optimal method in regard to CBD stone treatment. In 1991, the laparoscopic common bile duct exploration (LCBDE) which reflected the advantage of rigid scopes had risen to be a very promising minimally invasive alternative for the treatment of common bile duct (CBD) stone. Currently, there are mainly two kinds of minimally invasive treatments for choledocholithiasis, which refers to the "one-stage" laparoscopic method, LCBDE and the "sequential two-stage" method, ERCP followed by LC. Both methods are able to achieve the same therapeutic purpose. However, there has always been a controversy about the advantages and disadvantages due to lack of evidence from long-term follow-ups, especially the difference of long-term complications relate
Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province

Current Primary Outcome: Common bile duct stone recurrence [ Time Frame: Up to 5 years ]

Stone was diagnosed by MRI or CT whenever be confirmed after 3 months after procedures.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The proportion of patients with all stones removed [ Time Frame: Up to 8 hours ]
  • Operation time [ Time Frame: Up to 8 hours ]
    For arm1 (LCBED): the whole process of the operation; for arm2 (LC+ERCP): the total of the two procedures, LC and ERCP
  • Length of stay in hospital [ Time Frame: Up to 60 days ]
  • The total hospitalization costs [ Time Frame: Up to 60 days ]
  • Upper abdominal pain after each procedure by Numerical Rating Scale [ Time Frame: Up to 60 days ]
  • Hemorrhage [ Time Frame: Up to 60 days ]
    Maintained positive fecal occult blood test appears or Hb decreased by 10g/l
  • Perforation [ Time Frame: Up to 7 days ]
    CT scan shows retroperitoneal space fluid or gas
  • Acute cholangitis [ Time Frame: Up to 5 years ]
    Intermittent chills and fever after procedures
  • Bile leakage [ Time Frame: Up to 60 days ]
    Any bile juice aspirated from the abdominal cavity after procedures
  • Stricture of the bile duct [ Time Frame: Up to 5 years ]
    Any stricture appears after the procedures
  • Number of Death connected with the procedures and complications [ Time Frame: Up to 5 years ]


Original Secondary Outcome: Same as current

Information By: Hepatopancreatobiliary Surgery Institute of Gansu Province

Dates:
Date Received: July 30, 2015
Date Started: September 2015
Date Completion: August 2022
Last Updated: July 17, 2016
Last Verified: July 2016