Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 11:42 PM
Study NCT ID:
NCT05191693
Status:
COMPLETED
Last Update Posted:
2022-01-13
First Post:
2021-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Outcomes of Endoscopic Papillary Balloon Dilation for 8-12mm Bile Duct Stones: a Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D041761', 'term': 'Cholecystolithiasis'}], 'ancestors': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005705', 'term': 'Gallbladder 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': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2020-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-10', 'studyFirstSubmitDate': '2021-12-17', 'studyFirstSubmitQcDate': '2022-01-10', 'lastUpdatePostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stone recurrence after endoscopic papillary balloon dilation (EPBD) with endoscopic sphincterotomy (EST) in prior ERCP.', 'timeFrame': '22.4±6.2 months', 'description': 'Patients with CBD stones up to 8-12mm successfully treated by EPBD+EST from September 2018 to August 2020 were prospectively followed for at least 12 months. CBD stone recurrence was defined as recurrent stones confirmed by ERCP during the follow-up period. The maximum diameter of the balloon used was 15mm.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endoscopic papillary balloon dilation', 'Stone recurrence'], 'conditions': ['Endoscopic Papillary Balloon Dilation', 'Bile Duct Stones', 'Endoscopic Sphincterotomy', 'Stone Recurrence']}, 'descriptionModule': {'briefSummary': 'The investigators prospectively evaluated long-term outcomes of ELBPD+EST for CBD stones up to 8-12mm.\n\nEPBD+EST in patients with CBD stones up to 8-12mm appears to be associated with a very low (\\<3%) rate of long-term stone recurrence. The efficacy of EPBD for 8-12mm stones warrants further exploration in randomized trials.', 'detailedDescription': 'Consecutive patients with CBD stones up to 8-12mm successfully treated by EPBD+EST from September 2018 to August 2020 were prospectively followed for at least 12 months. CBD stone recurrence was defined as recurrent stones confirmed by ERCP during the follow-up period. The maximum diameter of the balloon used was 15mm.\n\nOverall, 72 patients (mean age: 67 years, 52.8% males) were included, of whom 22 (30.5%) had multiple CBD stones, 23 (31.9%) had a history of cholecystectomy, 13 (18.1%) had a periampullary diverticulum and 22 (30.5%) had a previous EST. The mean CBD diameter was 11.6±1mm, whereas a tapered duct was noted in 7 (9.7%). Post-procedural bleeding occurred in one case, treated successfully a with a fully covered metal stent. Mild cholangitis occurred in two cases. No cases with perforation or PEP were observed. During a mean follow-up of 22.4±6.2 months (range 13-36), CBD stones recurred in 2/72 (2.7%).\n\nEPBD+EST in patients with CBD stones up to 8-12mm appears to be associated with a very low (\\<3%) rate of long-term stone recurrence. The efficacy of EPBD for 8-12mm stones warrants further exploration in randomized trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients with CBD stones up to 8-12mm successfully treated by EPBD+EST from September 2018 to August 2020 ,who were prospectively followed for at least 12 months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:patients with ELBPD+EST for CBD stones up to 8-12mm from September 2018 to August 2020 -\n\nExclusion Criteria: Patients with bile duct stones less than 8mm or more than 12mm.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05191693', 'briefTitle': 'Long-term Outcomes of Endoscopic Papillary Balloon Dilation for 8-12mm Bile Duct Stones: a Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Venizelio General Hospital'}, 'officialTitle': 'Long-term Outcomes of Endoscopic Papillary Balloon Dilation for 8-12mm Bile Duct Stones: a Prospective Study', 'orgStudyIdInfo': {'id': 'Paspatis-balloon dilation'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with CBD stones up to 8-12mm', 'description': '72 patients (mean age: 67 years, 52.8% males) were included, of whom 22 (30.5%) had multiple CBD stones, 23 (31.9%) had a history of cholecystectomy, 13 (18.1%) had a periampullary diverticulum and 22 (30.5%) had a previous EST', 'interventionNames': ['Procedure: ERCP']}], 'interventions': [{'name': 'ERCP', 'type': 'PROCEDURE', 'otherNames': ['endoscopic papillary balloon'], 'description': 'endoscopic papillary balloon dilation (EPBD) with endoscopic sphincterotomy (EST', 'armGroupLabels': ['patients with CBD stones up to 8-12mm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71409', 'city': 'Heraklion', 'country': 'Greece', 'facility': '\'\'Benizelion" General Hospital', 'geoPoint': {'lat': 35.32787, 'lon': 25.14341}}], 'overallOfficials': [{'name': 'Gregorios Gregorios, Director', 'role': 'STUDY_DIRECTOR', 'affiliation': '\'\'Benizelion" General Hospital, Heraklion, Crete'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Venizelio General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'director of the gastroenterology department of Venizelio General Hospital', 'investigatorFullName': 'Gregorios Paspatis', 'investigatorAffiliation': 'Venizelio General Hospital'}}}}