Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 6:29 AM
Study NCT ID:
NCT06340594
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2024-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single-stage ERCP and Laparoscopic Cholecystectomy for Cholecystocholedocholithiasis: Which to Start With?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D041761', 'term': 'Cholecystolithiasis'}, {'id': 'D042883', 'term': 'Choledocholithiasis'}], 'ancestors': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D003137', 'term': 'Common Bile Duct Diseases'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002760', 'term': 'Cholangiopancreatography, Endoscopic Retrograde'}], 'ancestors': [{'id': 'D002758', 'term': 'Cholangiography'}, {'id': 'D011860', 'term': 'Radiography, Abdominal'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-30', 'studyFirstSubmitDate': '2024-03-25', 'studyFirstSubmitQcDate': '2024-03-25', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operative time operative time', 'timeFrame': 'time in minutes from intubation of the patient to the end of procedure', 'description': 'total operative time of both ERCP+LC'}], 'secondaryOutcomes': [{'measure': 'CBD clearance rate', 'timeFrame': 'up to 2 years', 'description': 'success rate of retrieval of stones'}, {'measure': 'Length of hospital stay', 'timeFrame': 'up to 2 weeks post-operative', 'description': 'days of hospital stay'}, {'measure': 'Mortality rate', 'timeFrame': 'up to 1 month postoperative', 'description': 'number of deaths intraoperative and postoperative related to surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Choledocholithiasis', 'ERCP', 'Laparoscopic cholecystectomy', 'Cholecystocholedocholithiasis'], 'conditions': ['Choledocholithiasis With Cholecystitis', 'Biliary Stones']}, 'referencesModule': {'references': [{'pmid': '20083751', 'type': 'BACKGROUND', 'citation': 'Rogers SJ, Cello JP, Horn JK, Siperstein AE, Schecter WP, Campbell AR, Mackersie RC, Rodas A, Kreuwel HT, Harris HW. Prospective randomized trial of LC+LCBDE vs ERCP/S+LC for common bile duct stone disease. Arch Surg. 2010 Jan;145(1):28-33. doi: 10.1001/archsurg.2009.226.'}, {'pmid': '32105889', 'type': 'BACKGROUND', 'citation': 'Muhammedoglu B, Kale IT. Comparison of the safety and efficacy of single-stage endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy versus two-stage ERCP followed by laparoscopic cholecystectomy six-to-eight weeks later: A randomized controlled trial. Int J Surg. 2020 Apr;76:37-44. doi: 10.1016/j.ijsu.2020.02.021. Epub 2020 Feb 24.'}, {'pmid': '27334962', 'type': 'BACKGROUND', 'citation': 'Elgeidie A, Atif E, Elebidy G. Intraoperative ERCP for management of cholecystocholedocholithiasis. Surg Endosc. 2017 Feb;31(2):809-816. doi: 10.1007/s00464-016-5036-1. Epub 2016 Jun 22.'}, {'pmid': '18321943', 'type': 'BACKGROUND', 'citation': 'Williams EJ, Green J, Beckingham I, Parks R, Martin D, Lombard M; British Society of Gastroenterology. Guidelines on the management of common bile duct stones (CBDS). Gut. 2008 Jul;57(7):1004-21. doi: 10.1136/gut.2007.121657. Epub 2008 Mar 5.'}, {'pmid': '36816010', 'type': 'BACKGROUND', 'citation': 'Nie S, Fu S, Fang K. Comparison of one-stage treatment versus two-stage treatment for the management of patients with common bile duct stones: A meta-analysis. Front Surg. 2023 Feb 3;10:1124955. doi: 10.3389/fsurg.2023.1124955. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'Chronic calculous cholecystitis is associated with common bile duct (CBD) stones in approximately 12% of patients. These patients need both cholecystectomy and CBD clearance of stones. The standard for cholecystectomy is laparoscopic cholecystectomy (LC) and the mostly common treatment used for CBD clearance is Endoscopic Retrograde Cholangiopancreatography (ERCP). The two interventions can be combined to be done at the same time under single anesthesia session. Studies of single stage ERCP+LC showed confirmed the safety and efficacy of the combined technique. However, some surgeons start with the ERCP while others start with LC.The aim of this study is to compare the start with ERCP followed by LC to the start with LC followed by ERCP when the two techniques are combined at the same session for treatment of chronic calculous cholecystitis associated with CBD stones regarding efficacy and safety of the two approaches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic calculous cholecystitis associated with common bile duct (CBD) stones admitted in a tertiary care hospital', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients underwent single stage ERCP+LC for cholecystocholedocholithiasis\n\nExclusion Criteria:\n\n* Contraindications to ERCP, or laparoscopic surgery\n* Cholangitis and pancreatitis\n* Previously failed ERCP'}, 'identificationModule': {'nctId': 'NCT06340594', 'briefTitle': 'Single-stage ERCP and Laparoscopic Cholecystectomy for Cholecystocholedocholithiasis: Which to Start With?', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Single-stage Endoscopic Retrograde Cholangiopancreatography and Laparoscopic Cholecystectomy for Cholecystocholedocholithiasis: Which to Start With?', 'orgStudyIdInfo': {'id': 'RF-2-2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A (ERCP 1st approach)', 'description': 'The patients first underwent ERCP followed by standard 4 port LC.', 'interventionNames': ['Procedure: Laproscopic cholecystectomy (LC)', 'Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)']}, {'label': 'Group B (LC 1st approach)', 'description': 'The patients first underwent LC followed by ERCP.', 'interventionNames': ['Procedure: Laproscopic cholecystectomy (LC)', 'Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)']}], 'interventions': [{'name': 'Laproscopic cholecystectomy (LC)', 'type': 'PROCEDURE', 'description': 'Removal of gallbladder via laparoscopy', 'armGroupLabels': ['Group A (ERCP 1st approach)', 'Group B (LC 1st approach)']}, {'name': 'Endoscopic Retrograde Cholangiopancreatography (ERCP)', 'type': 'PROCEDURE', 'description': 'Removal of bile duct stones via endoscopy', 'armGroupLabels': ['Group A (ERCP 1st approach)', 'Group B (LC 1st approach)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'state': 'Asyut Governorate', 'country': 'Egypt', 'facility': 'Faculty of Medicine-Assiut University -Assiut-Egypt', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer at General surgery department', 'investigatorFullName': 'Mohamad Raafat', 'investigatorAffiliation': 'Assiut University'}}}}