Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 1:14 AM
Study NCT ID:
NCT00416234
Status:
UNKNOWN
Last Update Posted:
2010-01-14
First Post:
2006-12-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laparoendoscopic Rendez Vous Versus Standard Two Stage Approach for the Management of Cholelithiasis/Choledocholithiasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D042883', 'term': 'Choledocholithiasis'}, {'id': 'D002769', 'term': 'Cholelithiasis'}], 'ancestors': [{'id': 'D003137', 'term': 'Common Bile Duct Diseases'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-01-13', 'studyFirstSubmitDate': '2006-12-26', 'studyFirstSubmitQcDate': '2006-12-26', 'lastUpdatePostDateStruct': {'date': '2010-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative hospital stay', 'timeFrame': 'from onset of intervention to discharge'}], 'secondaryOutcomes': [{'measure': 'success rate of CBD clearance', 'timeFrame': 'during ERCP'}, {'measure': 'failure rate of selective CBD cannulation', 'timeFrame': 'during ERCP'}, {'measure': 'incidence of multiple endoscopic procedures', 'timeFrame': 'within 30 days'}, {'measure': 'incidence of hyperamylasemia', 'timeFrame': 'within 48 hours post-ERCP'}, {'measure': 'incidence of severe pancreatitis (APACHE II score >6)', 'timeFrame': 'within 48 hours post-ERCP'}, {'measure': 'total hospital stay', 'timeFrame': 'from admission to discharge'}, {'measure': 'complications other but pancreatitis', 'timeFrame': 'within 30 days'}, {'measure': 'death', 'timeFrame': 'within 30 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Choledocholithiasis', 'Cholelithiasis']}, 'referencesModule': {'references': [{'pmid': '22261836', 'type': 'DERIVED', 'citation': 'Tzovaras G, Baloyiannis I, Zachari E, Symeonidis D, Zacharoulis D, Kapsoritakis A, Paroutoglou G, Potamianos S. Laparoendoscopic rendezvous versus preoperative ERCP and laparoscopic cholecystectomy for the management of cholecysto-choledocholithiasis: interim analysis of a controlled randomized trial. Ann Surg. 2012 Mar;255(3):435-9. doi: 10.1097/SLA.0b013e3182456ec0.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess whether combined intraoperative ERCP and CBD clearance with laparo-endoscopic rendez-vous during laparoscopic cholecystectomy (one stage approach) is or not superior to the standard practice of preoperative ERCP, sphincterotomy and CBD clearance followed by laparoscopic cholecystectomy (two stage approach) in patients with combined cholelithiasis and choledocholithiasis.', 'detailedDescription': 'The ideal management of concomitant cholelithiasis and choledocholithiasis is not known yet. There are several options, including one-stage or two-stage approaches. The most commonly used practice is the two-stage management which consists of preoperative ERCP, sphincterotomy and CBD clearance followed by laparoscopic cholecystectomy. However, with this approach, a number of patients will be submitted to an unnecessary ERCP while some others will develop complications, mainly pancreatitis due to inadvertent pancreatic duct cannulation. Laparo-endoscopic rendez-vous methods have been described in order to obtain selective CBD cannulation and omit the risk of post-ERCP pancreatitis. In this procedure, during laparoscopic cholecystectomy, a wire is inserted through the cystic duct into the common bile duct, advanced into the duodenum where is found endoscopically, gripped with a snare and retrieved through the mouth. The a sphincterotome is inserted over the wire and elective CBD cannulation is obtained to be followed by sphincterotomy and CBD clearance intraoperatively. The method has been described by several authors in small to moderate case series, its safety has been proven and it appears that reduces both the length of hospital stay and the incidence of post-ERCP pancreatitis.However, it has not been popularized and has never been tested over the standard two-stage management. In our hospital, the standard approach for cholelithiasis and choledocholithiasis has been, as well, the two-stage (preop ERCP and sphincterotomy followed by laparoscopic cholecystectomy)approach. We initially assessed the feasibility and safety of the laparo-endoscopic rendez vous with a pilot study and now we intend to compare the two methods in a prospective randomized trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients must be able to give informed consent preoperatively\n* ASA I-III\n* patients at high risk to have CBD stones (jaundice, cholangitis, grossly deranged LFTs, CBD stones found on US or MRCP)\n\nExclusion Criteria:\n\n* patients not fit for surgery (ASA IV)\n* previous ERCP and sphincterotomy\n* previous upper abdominal surgery\n* pregnancy at time of surgery'}, 'identificationModule': {'nctId': 'NCT00416234', 'briefTitle': 'Laparoendoscopic Rendez Vous Versus Standard Two Stage Approach for the Management of Cholelithiasis/Choledocholithiasis', 'organization': {'class': 'OTHER', 'fullName': 'University of Thessaly'}, 'officialTitle': 'Laparoendoscopic Rendez Vous (Intraoperative ERCP) vs Two Stage Approach (Preoperative ERCP Followed by Laparoscopic Cholecystectomy) for the Management of Cholelithiasis/Choledocholithiasis', 'orgStudyIdInfo': {'id': 'Larissa CBD stones trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Laparoendoscopic Rendez vous (one stage management of cholelithiasis/choledocholithiasis)', 'interventionNames': ['Procedure: Laparoendoscopic Rendez vous']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'preoperative ERCP and CBD clearance followed by lap cholecystectomy (two stage management of cholelithiasis/choledocholithiasis)', 'interventionNames': ['Procedure: preoperative ERCP and CBD clearance']}], 'interventions': [{'name': 'Laparoendoscopic Rendez vous', 'type': 'PROCEDURE', 'description': 'intraoperative ERCP for CBD clearance during laparoscopic cholecystectomy', 'armGroupLabels': ['1']}, {'name': 'preoperative ERCP and CBD clearance', 'type': 'PROCEDURE', 'description': 'ERCP and CBD clearance followed by laparoscopic cholecystectomy', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '413 35', 'city': 'Larissa', 'state': 'Thessaly', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'George Tzovaras, MD', 'role': 'CONTACT', 'email': 'gtzovaras@hotmail.com', 'phone': '+30 2410 682730'}, {'name': 'Ioannis Baloyiannis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Spyros Potamianos, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'George Paroutoglou, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Georgia Stamatiou, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital of Larissa', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}], 'centralContacts': [{'name': 'George Tzovaras, MD', 'role': 'CONTACT', 'email': 'gtzovaras@hotmail.com', 'phone': '+30 2410 682730'}, {'name': 'Ioannis Baloyiannis, MD', 'role': 'CONTACT', 'email': 'balioan@hotmail.com', 'phone': '+30 2410 682728'}], 'overallOfficials': [{'name': 'Constantine Hatzitheofilou, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Thessaly, School of Medicine'}, {'name': 'George Tzovaras, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Thessaly, School of Medicine'}, {'name': 'Ioannis Baloyiannis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Larissa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Thessaly', 'class': 'OTHER'}, 'collaborators': [{'name': 'Larissa University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'George Tzovaras, MD', 'oldOrganization': 'University of Thessaly, School of Medicine'}}}}