Overview

This trial is active, not recruiting.

Condition cholelithiasis associated with common bile duct stones
Treatment tissue sampling from peritoneum of the gallbladder
Phase phase 0
Sponsor Bezmialem Vakif University
Start date September 2012
End date June 2015
Trial size 60 participants
Trial identifier NCT01687959, BEZM-LC-postERCP

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
measurements of peritoneal fibrinolysis using tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator, and plasminogen activator inhibitor type 1
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
(Active Comparator)
surgical outcomes of laparoscopic cholecystectomy
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

Primary Outcomes

Measure
measurement of peritoneal fibrinolytic response following endoscopic retrograde cholangiography
time frame: six months

Secondary Outcomes

Measure
surgical outcomes of laparoscopic cholecystectomy following endoscopic retrograde cholangiography
time frame: six months

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - cholelithiasis following endoscopic retrograde cholangiography for acute biliary pancreatitis Exclusion Criteria: - contraindication to laparoscopy - unsuccessful endoscopic retrograde cholangiography - complicated acute biliary pancreatitis

Additional Information

Official title Prospective Randomized Clinical Study for Timing of Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiography for Acute Biliary Pancreatitis
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Bezmialem Vakif University.