Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-02-01 @ 7:05 PM
Study NCT ID:
NCT01687959
Status:
UNKNOWN
Last Update Posted:
2015-01-28
First Post:
2012-09-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Timing of Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiography for Acute Biliary Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D042883', 'term': 'Choledocholithiasis'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003137', 'term': 'Common Bile Duct Diseases'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-27', 'studyFirstSubmitDate': '2012-09-14', 'studyFirstSubmitQcDate': '2012-09-14', 'lastUpdatePostDateStruct': {'date': '2015-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measurement of peritoneal fibrinolytic response following endoscopic retrograde cholangiography', 'timeFrame': 'six months', 'description': 'measurement of tissue concentrations of tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator , and plasminogen activator inhibitor type 1'}], 'secondaryOutcomes': [{'measure': 'surgical outcomes of laparoscopic cholecystectomy following endoscopic retrograde cholangiography', 'timeFrame': 'six months', 'description': 'evaluation of surgical outcomes including operating time, morbidity and mortality of laparoscopic cholecystectomy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cholelithiasis', 'laparoscopic cholecystectomy', 'endoscopic sphincterotomy', 'choledocholithiasis'], 'conditions': ['Cholelithiasis Associated With Common Bile Duct Stones']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nPatients 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.\n\nPeritoneal fibrinolytic activity and surgical outcomes are going to be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cholelithiasis following endoscopic retrograde cholangiography for acute biliary pancreatitis\n\nExclusion Criteria:\n\n* contraindication to laparoscopy\n* unsuccessful endoscopic retrograde cholangiography\n* complicated acute biliary pancreatitis'}, 'identificationModule': {'nctId': 'NCT01687959', 'briefTitle': 'Timing of Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiography for Acute Biliary Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Prospective Randomized Clinical Study for Timing of Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiography for Acute Biliary Pancreatitis', 'orgStudyIdInfo': {'id': 'BEZM-LC-postERCP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'activity of peritoneal fibrinolysis', 'description': 'measurements of peritoneal fibrinolysis using tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator, and plasminogen activator inhibitor type 1', 'interventionNames': ['Other: tissue sampling from peritoneum of the gallbladder']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'surgical outcomes', 'description': 'surgical outcomes of laparoscopic cholecystectomy', 'interventionNames': ['Other: tissue sampling from peritoneum of the gallbladder']}], 'interventions': [{'name': 'tissue sampling from peritoneum of the gallbladder', 'type': 'OTHER', 'description': 'tissue sampling from peritoneum of the gallbladder during laparoscopic cholecystectomy after an acute attack of acute biliary pancreatitis', 'armGroupLabels': ['activity of peritoneal fibrinolysis', 'surgical outcomes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'department of general surgery; Bezmialem vakif university', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, general surgeon', 'investigatorFullName': 'Mustafa Hasbahceci', 'investigatorAffiliation': 'Bezmialem Vakif University'}}}}