Comparison of LCBDE vs ERCP + LC for Choledocholithiasis
Condition: Choledocholithiasis
MeSH terms: Choledocholithiasis
Study type: Interventional

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 description: 
      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 related to Oddi's sphincter functional status, which importantly
      refers to stone recurrence rates and cholangitis.

      The potential long-term complications resulted from EST remains an issue now. It is believed
      that EST handles Oddi's sphincter stenosis, regurgitation cholangitis, and higher
      cholangiocarcinoma risks in a long run. By virtue of ERCP, multiple high stone clearance
      rates (87%~97%) were reported, but meanwhile high re-ERCP rates (around 25%) were also
      indicated because of stone residual, and whether great stone residual rates was linked to
      future stone recurrence and repeated cholangitis is not clear. Several randomized controlled
      trial (RCT) studies had compared ERCP plus LC and LCBDE, the results were similar to the
      aspects of stone removal rates, costs, and patient acceptance. However, the postoperative
      cholangitis rate of one single center study is quite different from another. Moreover, few
      studies have related the stone recurrence rate in the long term follow-up. Obviously,
      previous RCT studies were limited by few comparison of ERCP followed by LC versus LCBDE in
      long-term complications, especially stone recurrence and cholangitis. Therefore, this
      multicenter randomize control study is designed prospectively to compare the stone recurrence
      and cholangitis rates between ERCP plus LC and LCBDE which can reflects the valuable of
      Oddi's sphincter protection during the disease management, further dedicating the treatment
      of gallbladder and common duct stone.
    

Intervention name(s): Laparoscopy; Endoscopy
Intervention type(s): Procedure; Procedure
Intervention description(s): After removing the gallbladder, Laparoscopic common bile duct exploration (LCBDE) was performed by one fulltime attending in laparoscopy in a routine fashion. Access from the opening of the anterior wall of common bile duct or from the dilated cystic duct was acceptable, removed stone(s) and irrigated the duct followed by choledochoscope detection simultaneously. Cholangiograms were also can be a alternative method to obtain stone clearance. If needed, all fluoroscopy was performed by the principal author in the presence of and concurrence with the ERCP endoscopist. Once the LCBDE was completed, the incision of the bile duct was sewed intermittently by absorbed threads, or ligated cystic duct. T-tube was acceptable if needed.; Initially endoscopic retrograde cholangiopancreatography (ERCP) was performed by a fulltime attending and concurrence of the principal author in endoscopy. Patients randomized to ERCP+ LC group were scheduled to undergo the endoscopic procedure using fluoroscopy in the endoscopy center under moderate sedation (principally intravenous midazolam and meperidine) prior to the intended laparoscopy. Gastric intestinal atony during ERCP was routinely achieved using scopolamine butylbromide injection. Sphincterotomy (EST) and Endoscopic papillary balloon dilatation (EPBD) can be choose accordingly. The laparoscopic cholecystectomy was subsequently performed as soon as technically feasible following the ERCP in one month.
Other intervention name(s): Laparoscopic common bile duct exploration (LCBDE); Endoscopic Retrograde cholangiopancreatography (ERCP)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cholangiopancreatography; Endoscopic; Common bile duct; Complication; Recurrence; Laparoscopic