Clinical trial NCT01687959: Timing of Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiography for Acute Biliary Pancreatitis
Official title: Prospective Randomized Clinical Study for Timing of Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiography for Acute Biliary Pancreatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Cholelithiasis Associated With Common Bile Duct Stones
Keywords: cholelithiasis
laparoscopic cholecystectomy
endoscopic sphincterotomy
choledocholithiasis
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2012-09-19
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* cholelithiasis following endoscopic retrograde cholangiography for acute biliary pancreatitis

Exclusion Criteria:

* contraindication to laparoscopy
* unsuccessful endoscopic retrograde cholangiography
* complicated acute biliary pancreatitis

Primary outcomes:
measure: measurement of peritoneal fibrinolytic response following endoscopic retrograde cholangiography
timeFrame: six months
Secondary outcomes:
measure: surgical outcomes of laparoscopic cholecystectomy following endoscopic retrograde cholangiography
timeFrame: six months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: department of general surgery; Bezmialem vakif university
Study officials:
References: