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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Bezmialem Vakif University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Mustafa Hasbahceci, Bezmialem Vakif University
ClinicalTrials.gov Identifier:
NCT01687959
First received: September 14, 2012
Last updated: September 18, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Cholelithiasis Associated With Common Bile Duct Stones
Other: tissue sampling from peritoneum of the gallbladder
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Prospective Randomized Clinical Study for Timing of Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiography for Acute Biliary Pancreatitis

Resource links provided by NLM:


Further study details as provided by Bezmialem Vakif University:

Primary Outcome Measures:
  • measurement of peritoneal fibrinolytic response following endoscopic retrograde cholangiography [ Time Frame: six months ] [ Designated as safety issue: No ]
    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:
  • surgical outcomes of laparoscopic cholecystectomy following endoscopic retrograde cholangiography [ Time Frame: six months ] [ Designated as safety issue: No ]
    evaluation of surgical outcomes including operating time, morbidity and mortality of laparoscopic cholecystectomy


Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Active Comparator: surgical outcomes
surgical outcomes of laparoscopic cholecystectomy
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

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01687959

Locations
Turkey
department of general surgery; Bezmialem vakif university
Istanbul, Turkey, 34093
Sponsors and Collaborators
Bezmialem Vakif University
  More Information

No publications provided

Responsible Party: Mustafa Hasbahceci, MD, general surgeon, Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT01687959     History of Changes
Other Study ID Numbers: BEZM-LC-postERCP
Study First Received: September 14, 2012
Last Updated: September 18, 2012
Health Authority: Turkey: Bezmialem Vakif University Faculty of Medicine

Keywords provided by Bezmialem Vakif University:
cholelithiasis
laparoscopic cholecystectomy
endoscopic sphincterotomy
choledocholithiasis

Additional relevant MeSH terms:
Pancreatitis
Cholelithiasis
Cholecystolithiasis
Gallstones
Pancreatic Diseases
Digestive System Diseases
Biliary Tract Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 29, 2014