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

Early Phase 1

• Conditions: Cholelithiasis Associated With Common Bile Duct Stones
• Interventions: Other: tissue sampling from peritoneum of the gallbladder

• Registration Number: NCT01687959
• Lead Sponsor: Bezmialem Vakif University

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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-14
• Study First Submitted QC: 2012-09-14
• Study First Posted: 2012-09-19
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-27
• Last Update Posted: 2015-01-28
• Primary Completion: 2015-06
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• cholelithiasis following endoscopic retrograde cholangiography for acute biliary pancreatitis

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
activity of peritoneal fibrinolysis	tissue sampling from peritoneum of the gallbladder	measurements of peritoneal fibrinolysis using tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator, and plasminogen activator inhibitor type 1
surgical outcomes	tissue sampling from peritoneum of the gallbladder	surgical outcomes of laparoscopic cholecystectomy

Primary Outcome Measures

Name	Time	Method
measurement of peritoneal fibrinolytic response following endoscopic retrograde cholangiography	six months	measurement of tissue concentrations of tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator , and plasminogen activator inhibitor type 1

Secondary Outcome Measures

Name	Time	Method
surgical outcomes of laparoscopic cholecystectomy following endoscopic retrograde cholangiography	six months	evaluation of surgical outcomes including operating time, morbidity and mortality of laparoscopic cholecystectomy

Trial Locations

Locations (1)

department of general surgery; Bezmialem vakif university; 🇹🇷 Istanbul, Turkey