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

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ClinicalTrials.gov Identifier: NCT01687959
Recruitment Status : Unknown
Verified January 2015 by Mustafa Hasbahceci, Bezmialem Vakif University.
Recruitment status was:  Active, not recruiting
First Posted : September 19, 2012
Last Update Posted : January 28, 2015
Sponsor:
Information provided by (Responsible Party):
Mustafa Hasbahceci, Bezmialem Vakif University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cholelithiasis Associated With Common Bile Duct Stones Other: tissue sampling from peritoneum of the gallbladder Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective Randomized Clinical Study for Timing of Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiography for Acute Biliary Pancreatitis
Study Start Date : September 2012
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : August 2015

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687959


Locations
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Turkey
department of general surgery; Bezmialem vakif university
Istanbul, Turkey, 34093
Sponsors and Collaborators
Bezmialem Vakif University
More Information
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Responsible Party: Mustafa Hasbahceci, MD, general surgeon, Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT01687959    
Other Study ID Numbers: BEZM-LC-postERCP
First Posted: September 19, 2012    Key Record Dates
Last Update Posted: January 28, 2015
Last Verified: January 2015
Keywords provided by Mustafa Hasbahceci, Bezmialem Vakif University:
cholelithiasis
laparoscopic cholecystectomy
endoscopic sphincterotomy
choledocholithiasis
Additional relevant MeSH terms:
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Pancreatitis
Cholelithiasis
Cholecystolithiasis
Gallstones
Pancreatic Diseases
 Digestive System Diseases
Biliary Tract Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical