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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 2015

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.

Interventions

  • Other: tissue sampling from peritoneum of the gallbladder
    • tissue sampling from peritoneum of the gallbladder during laparoscopic cholecystectomy after an acute attack of acute biliary pancreatitis

Arms, Groups and Cohorts

  • Active Comparator: activity of peritoneal fibrinolysis
    • measurements of peritoneal fibrinolysis using tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator, and plasminogen activator inhibitor type 1
  • Active Comparator: surgical outcomes
    • surgical outcomes of laparoscopic cholecystectomy

Clinical Trial Outcome Measures

Primary Measures

  • measurement of peritoneal fibrinolytic response following endoscopic retrograde cholangiography
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • cholelithiasis following endoscopic retrograde cholangiography for acute biliary pancreatitis Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bezmialem Vakif University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mustafa Hasbahceci, MD, general surgeon – Bezmialem Vakif University

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