Timing of Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiography for Acute Biliary Pancreatitis
This trial is active, not recruiting.
|Condition||cholelithiasis associated with common bile duct stones|
|Treatment||tissue sampling from peritoneum of the gallbladder|
|Sponsor||Bezmialem Vakif University|
|Start date||September 2012|
|End date||June 2015|
|Trial size||60 participants|
|Trial identifier||NCT01687959, BEZM-LC-postERCP|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
|Masking||single blind (subject)|
measurement of peritoneal fibrinolytic response following endoscopic retrograde cholangiography
time frame: six months
surgical outcomes of laparoscopic cholecystectomy following endoscopic retrograde cholangiography
time frame: six months
Male or female participants of any age.
Inclusion Criteria: - cholelithiasis following endoscopic retrograde cholangiography for acute biliary pancreatitis Exclusion Criteria: - contraindication to laparoscopy - unsuccessful endoscopic retrograde cholangiography - complicated acute biliary pancreatitis
|Official title||Prospective Randomized Clinical Study for Timing of Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiography for Acute Biliary Pancreatitis|
|Description||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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