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

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 |
- 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
- 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

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- cholelithiasis following endoscopic retrograde cholangiography for acute biliary pancreatitis
Exclusion Criteria:
- contraindication to laparoscopy
- unsuccessful endoscopic retrograde cholangiography
- complicated acute biliary pancreatitis

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
Turkey | |
department of general surgery; Bezmialem vakif university | |
Istanbul, Turkey, 34093 |
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 |
cholelithiasis laparoscopic cholecystectomy endoscopic sphincterotomy choledocholithiasis |
Pancreatitis Cholelithiasis Cholecystolithiasis Gallstones Pancreatic Diseases |
Digestive System Diseases Biliary Tract Diseases Gallbladder Diseases Calculi Pathological Conditions, Anatomical |