Cholelithiasis Associated With Common Bile Duct Stones Clinical Trial
Official title:
Prospective Randomized Clinical Study for Timing of Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiography for Acute Biliary Pancreatitis
Timing of laparoscopic cholecystectomy following after endoscopic retrograde cholangiography for acute biliary pancreatitis is a controversial issue. There are still many confounding findings offering either early laparoscopic cholecystectomy within 72 hours following endoscopic sphincterotomy or delayed surgery after 6 weeks. Peritoneal plasmin system is known to be an important factor in peritoneal healing and adhesion formation. Measurement of tissue concentrations of tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator, and plasminogen activator inhibitor type 1 are thought to be helpful to show peritoneal adhesions after endoscopic sphincterotomy.
Peritoneal fibrinolysis is crucial in peritoneal healing processes and subsequent adhesion
formation. It is expected that endoscopic retrograde cholangiography is a trauma causing
adhesions around the hepatobiliary area. Such adhesions may cause some difficulty for
consequent gallbladder surgery. For that reason, tissue measurements of factors indicating
degree of peritoneal healing and adhesion is helpful for timing of such surgical
interventions.
Patients are going to be randomized to early and delayed surgery groups. Sampling of
peritoneum around the gallbladder during laparoscopic cholecystectomy in patients after
endoscopic retrograde cholangiography is performed. Tissue concentrations of tissue-type
plasminogen activator and its specific activity, urokinase-type plasminogen activator, and
plasminogen activator inhibitor type 1 are going to be studied by using commercial assays.
Peritoneal fibrinolytic activity and surgical outcomes are going to be compared.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment