Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-30 @ 11:54 PM
Study NCT ID:
NCT07084493
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-07
First Post:
2025-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
*Effect of Prophylactic CBD Stenting Versus Non Stenting on Recurrence of CBD Stones in Patients Awaiting Cholecystectomy*
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Following ERCP and biliary duct clearance, participants will be randomly assigned in a 1:1 ratio to either:\n\nStent Group: Placement of a prophylactic CBD stent will be placed. Control Group: No stent placement after biliary clearance. Patients will be monitored every month until cholecystectomy or up to 3 months, whichever comes first.\n\nFollow-up includes:\n\nClinical assessment. LFTs and pancreatic enzymes. Imaging: US (MRCP if symptomatic). Stent removal (if placed) at 3 months or earlier if symptomatic. Repeat ERCP for recurrence.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-02', 'studyFirstSubmitDate': '2025-07-15', 'studyFirstSubmitQcDate': '2025-07-22', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of CBD stones within 3 months, confirmed by imaging or ERCP.', 'timeFrame': '3 months', 'description': 'Recurrence of CBD stones within 3 months, confirmed by imaging or ERCP.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CBD stones, ERCP'], 'conditions': ['Calcular Obstructive Jaundice']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/26343220', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Primary objective:\n\nCompare recurrence rates of CBD stones in stented versus non-stented patients.\n\nSecondary objectives:\n\nIdentify predictors of stone recurrence. Assess the incidence and risk factors for post-ERCP complications. Evaluate time to recurrence and rate of hospital readmissions. Explore impact on quality of life and ease of subsequent cholecystectomy.', 'detailedDescription': 'Choledocholithiasis, the presence of stones in the common bile duct (CBD), occurs in 10-20% of patients with symptomatic gallstones and can lead to severe complications such as obstructive jaundice, cholangitis, and pancreatitis Endoscopic retrograde cholangiopancreatography (\\*\\*ERCP\\*\\*) with stone extraction is the gold standard treatment, achieving \\>90% success rates in ductal clearance.\n\nDespite successful initial clearance, CBD stone recurrence remains a significant issue, with reported rates ranging from 4% to 24% .\n\nTo reduce recurrence, prophylactic biliary stenting has been proposed, particularly in high-risk patients (e.g., large or multiple stones, dilated CBD, periampullary diverticulum) However, its routine use remains controversial due to conflicting evidence on efficacy, stent-related complications (e.g., migration, occlusion, cholangitis), and increased healthcare costs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '"Inclusion Criteria":\n\n* Age \\> 18 years.\n* Documented CBD stones by various imaging or ERCP.\n* Successful biliary clearance by ERCP.\n* Scheduled for elective cholecystectomy within 3 months.\n* Provide written informed consent.\n\n"Exclusion Criteria":\n\n* Previous biliary surgery.\n* Known malignancy involving the biliary system.\n* Comorbid conditions preventing surgery such as bleeding tendency.\n* Pregnancy.\n* Failure to obtain consent.\n* Failed stone clearance.'}, 'identificationModule': {'nctId': 'NCT07084493', 'briefTitle': '*Effect of Prophylactic CBD Stenting Versus Non Stenting on Recurrence of CBD Stones in Patients Awaiting Cholecystectomy*', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': '*Effect of Prophylactic Common Bile Duct Stenting Versus Non Stenting on Recurrence of Common Bile Duct Stones in Patients Awaiting Cholecystectomy*', 'orgStudyIdInfo': {'id': 'ERCP in CBD stones'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CASE WITH cbd STONES', 'description': 'Age \\> 18 years.\n\nDocumented CBD stones by various imaging or ERCP.\n\nSuccessful biliary clearance by ERCP.\n\nScheduled for elective cholecystectomy within 3 months.\n\nProvide written informed consent.', 'interventionNames': ['Device: CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm OR double-pigtail stent', 'Device: biliary stent']}], 'interventions': [{'name': 'CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm OR double-pigtail stent', 'type': 'DEVICE', 'description': 'prophylactic CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm double-pigtail stent', 'armGroupLabels': ['CASE WITH cbd STONES']}, {'name': 'biliary stent', 'type': 'DEVICE', 'description': 'prophylactic CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm double-pigtail stent', 'armGroupLabels': ['CASE WITH cbd STONES']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71511', 'city': 'Asyut', 'country': 'Egypt', 'contacts': [{'name': 'Assiut university assiut university', 'role': 'CONTACT', 'email': 'hudamokhtar2571994@aun.edu.eg', 'phone': '01154664323'}], 'facility': 'Assiut university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Huda Mokhtar Huda Mokhtar, Assistant lecturer, master degree', 'role': 'CONTACT', 'email': 'hudamokhtar2571994@aun.edu.eg', 'phone': '0201154664323'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': "SPSS version 22 will be used. Continuous variables: mean ± SD or median (IQR), compared via t-test or Mann-Whitney.\n\nCategorical variables: chi-square or Fisher's exact test. Kaplan-Meier for time-to-event outcomes. Multivariate regression to identify predictors. P \\< 0.05 considered significant."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Huda Mokhtar Salim', 'investigatorAffiliation': 'Assiut University'}}}}