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

Bezmialem Vakif University

Status and phase: Unknown; Early Phase 1

Conditions: Cholelithiasis Associated With Common Bile Duct Stones

Treatments: Other: tissue sampling from peritoneum of the gallbladder

Study type: Interventional

Funder types: Other

Identifiers

NCT01687959

BEZM-LC-postERCP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• cholelithiasis following endoscopic retrograde cholangiography for acute biliary pancreatitis

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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60 participants in 2 patient groups

activity of peritoneal fibrinolysis

Active Comparator group

Description:

measurements of peritoneal fibrinolysis using tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator, and plasminogen activator inhibitor type 1

Treatment:

Other: tissue sampling from peritoneum of the gallbladder

surgical outcomes

Active Comparator group

Description:

surgical outcomes of laparoscopic cholecystectomy

Treatment:

Other: tissue sampling from peritoneum of the gallbladder