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UnknownNCT01687959

Timing of Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiography for Acute Biliary Pancreatitis

Prospective Randomized Clinical Study for Timing of Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiography for Acute Biliary Pancreatitis

Status
Unknown
Phase
EARLY_Phase 1
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Bezmialem Vakif University · Academic / Other
Sex
All
Age
Healthy volunteers
Accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
OTHERtissue sampling from peritoneum of the gallbladdertissue sampling from peritoneum of the gallbladder during laparoscopic cholecystectomy after an acute attack of acute biliary pancreatitis

Timeline

Start date
2012-09-01
Primary completion
2015-06-01
Completion
2015-08-01
First posted
2012-09-19
Last updated
2015-01-28

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT01687959. Inclusion in this directory is not an endorsement.