Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
Study NCT ID:
NCT06287112
Status:
RECRUITING
Last Update Posted:
2025-02-20
First Post:
2024-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevention of Acute Cholecystitis With ETGBD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D041881', 'term': 'Cholecystitis, Acute'}], 'ancestors': [{'id': 'D002764', 'term': 'Cholecystitis'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2024-02-20', 'studyFirstSubmitQcDate': '2024-02-28', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence rate of acute cholecystitis', 'timeFrame': '2 months from the date of stent placement', 'description': 'Diagnosis of Acute cholecystitis will be based on the Tokyo Guidelines 2018'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Malignant biliary obstruction', 'Fully covered self expandable metal stent', 'Endoscopic transpapillary gallbladder drainage', 'Preventive Effect', 'Acute cholecystitis'], 'conditions': ['Biliary Obstruction', 'Acute Cholecystitis']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn about Efficacy of the ETGBD parallel insertion with fully covered self-expandable metal stent for preventing acute cholecystitis in patients with low cystic duct insertion.\n\nIn this study, we hypothesized that endoscopic transpapillary gallbladder drainage (ETGBD) with parallel insertion of a fully covered self-expanding metal stent(FCSEMS) through an endoscopic biliary drainage tunnel is superior in preventing complications such as cholecystitis when the gallbladder ducts confluence within the distal third of the common bile duct. And we aimed to confirm its efficacy by comparing the frequency, severity, and rate of invasive additional procedures due to cholecystitis complications to provide evidence of clinical utility.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults 19 years of age or older\n2. Patients requiring endoscopic retrograde cholangiography and drainage for therapeutic purposes.\n3. Patients with imaging (CT, Cholangiogram) confirmed confluence of the cystic duct with the distal third of the common bile duct.\n4. Patients who have voluntary informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients who have undergone percutaneous/surgical bile duct or gallbladder drainage prior to study enrollment.\n* Patients with anatomic deformity of the upper gastrointestinal tract after gastric or hepatobiliary surgery\n* Patients with concomitant gastric/duodenal obstruction\n* Patients with confirmed or suspected cystic duct obstruction on imaging studies\n* Patients with acute cholecystitis, acute pancreatitis\n* Patients who underwent cholecystectomy\n* Patients with a life expectancy of less than 3 months\n* Patients who are otherwise unable to undergo endoscopic retrograde cholangiopancreatography'}, 'identificationModule': {'nctId': 'NCT06287112', 'briefTitle': 'Prevention of Acute Cholecystitis With ETGBD', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Efficacy of ETGBD Parallel Insertion With Fully Covered Self-expandable Metal Stent for Preventing Acute Cholecystitis in Patients With Low Cystic Duct Insertion', 'orgStudyIdInfo': {'id': 'PAC-ETGBD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PAC-ETGBD (Prevention of Acute Cholecystitis with ETGBD)', 'interventionNames': ['Device: Endoscopic transpapillary gallbladder drainage (ETGBD)']}], 'interventions': [{'name': 'Endoscopic transpapillary gallbladder drainage (ETGBD)', 'type': 'DEVICE', 'description': 'Fully covered self-Expandable metal stent with Endoscopic transpapillary gallbladder drainage (ETGBD) in patient with cystic duct low insertion', 'armGroupLabels': ['PAC-ETGBD (Prevention of Acute Cholecystitis with ETGBD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Woo Hyun Paik, MD, PhD', 'role': 'CONTACT', 'email': 'iatrus@snu.ac.kr', 'phone': '+82220722228'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Myeong Hwan Lee, MD.', 'role': 'CONTACT', 'email': 'dlaudghks01@snu.ac.kr', 'phone': '+82-10-7733-6494'}], 'overallOfficials': [{'name': 'Woo Hyun Paik, MD., PhD.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Woo Hyun Paik', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}