Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-01-16 @ 1:31 AM
Study NCT ID:
NCT02394327
Status:
COMPLETED
Last Update Posted:
2016-01-05
First Post:
2015-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Nasogallbladder Drainage Versus Gallbladder Stenting Before Cholecystecomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D041881', 'term': 'Cholecystitis, Acute'}, {'id': 'D042882', 'term': 'Gallstones'}], 'ancestors': [{'id': 'D002764', 'term': 'Cholecystitis'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D041761', 'term': 'Cholecystolithiasis'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-04', 'studyFirstSubmitDate': '2015-02-18', 'studyFirstSubmitQcDate': '2015-03-17', 'lastUpdatePostDateStruct': {'date': '2016-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Techncal success rate', 'timeFrame': 'From the time of randomization until the time when the endoscopic procedure is ended, assessed up to 24hours', 'description': 'This outcome was defined as successful deep GB cannulation and placement of assigned drainage device by randomization, and determined by the operator based on the fluoroscoic images of the procedures.'}], 'secondaryOutcomes': [{'measure': 'Clinical success rate', 'timeFrame': 'From the date of randomization until the date of clinical improvement (fever, leukocytosis, abdominal pain), assessed up to 72 hours', 'description': "This outcome was defined as improvement of three clinical parameters of acute cholecystitis (fever, abdominal pain, leukocytosis) within 72 hours following either type of ETGD procedure, and assessed by the review of patient's mediacal records."}, {'measure': 'early adverse event', 'timeFrame': 'From the date of the randomization until the date of the elective cholecystectomy, assessed up to 2 weeks', 'description': "This outcome was defined as any procedure related event occurring between the endoscopic procedure and elective cholecystectomy, and assessed by the patient's medical records."}]}, 'conditionsModule': {'conditions': ['Cholecystitis, Acute', 'Common Bile Duct Calculi']}, 'descriptionModule': {'briefSummary': 'Early laparoscopic cholecystectomy is the current standard therapy for acute cholecystitis, but temporary decompression of the gallbladder (GB) through percutaneous or endoscopic route can be required to alleviate inflammatory process and reach an appropriate time for elective surgery in patients with high operative risk or marked local inflammation or organ dysfunction. Also preoperative endoscopic retrograde cholangiopancreatography (ERCP) is often needed because common bile duct (CBD) stone is accompanied in patients with acute cholecystitis at reported rate from 7-20%.\n\nTwo-steps approach of percutaneous transhepatic GB drainage (PTGBD) followed by ERCP or vice versa has been performed for the treatment of acute cholecystitis with concomitant CBD stone who are not suitable for urgent cholecystectomy. However single-step drainage of CBD and GB through ERCP and endoscopic transpapillary GB drainage (ETGD) using nasocystic tube or plastic stent has alternatively been attempted in patients who have contraindications for PTGBD. In clinical practice, many endoscopists have hesitated to perform ETGD because of its relatively low technical success rate and specific concern about post-ERCP adverse event but it minimizes catheter keeping duration, and provides effective clinical improvement via physiologic route.\n\nCurrently there are scarce data on if ETGD using nasocystic tube or plastic stent are comparable in terms of clinical efficacy and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* grade II or III acute cholecystitis met Tokyo 13 diagnostic criteria\n* a high suspicion of CBD stone based on laboratory and imaging study\n* informed consent given.\n\nExclusion Criteria:\n\n* bilo-pancreatic malignancy or surgically altered enteric anatomy\n* subsequent elective surgery is expected to be impossible even after GB decompression based on American Society of Anesthesiologist class'}, 'identificationModule': {'nctId': 'NCT02394327', 'briefTitle': 'Endoscopic Nasogallbladder Drainage Versus Gallbladder Stenting Before Cholecystecomy', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'Endoscopic Naso-gallbladder Drainage Versus Gallbladder Stenting Before Elective Cholecystectomy in Patients With Acute Cholecystitis and a High Suspicion of Common Bile Duct Stone; A Prospective Randomized Preliminary Study', 'orgStudyIdInfo': {'id': 'AJIRB-MED-MDB-11-318'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Endoscopic nasogallbladder drainage', 'description': 'If GB cannulation was achieved and the wire was coiled in the GB, 5 to 7-Fr Pigtail type naso-cholecystic drainage tube (Liguory nasal biliary drainage set; Wilson-Cook Medical, Salem, NC, USA) was placed into the GB', 'interventionNames': ['Device: 7-Fr Pigtail type naso-cholecystic drainage tube (Liguory nasal biliary drainage set; Wilson-Cook Medical, Salem, NC, USA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Endoscopic gallbladder stenting', 'description': 'If GB cannulation was achieved and the wire was coiled in the GB, 7-Fr double pigtail plastic stent (Zimmon; Wilson-Cook Medical, Salem, NC, USA) was placed into the GB', 'interventionNames': ['Device: 7-Fr double pigtail plastic stent (Zimmon; Wilson-Cook Medical, Salem, NC, USA)']}], 'interventions': [{'name': '7-Fr Pigtail type naso-cholecystic drainage tube (Liguory nasal biliary drainage set; Wilson-Cook Medical, Salem, NC, USA)', 'type': 'DEVICE', 'description': 'Endoscopic', 'armGroupLabels': ['Endoscopic nasogallbladder drainage']}, {'name': '7-Fr double pigtail plastic stent (Zimmon; Wilson-Cook Medical, Salem, NC, USA)', 'type': 'DEVICE', 'armGroupLabels': ['Endoscopic gallbladder stenting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '443-380', 'city': 'Suwon', 'state': 'Gyeonggido', 'country': 'South Korea', 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'Byung Moo Yoo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ajou University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Yoo Byung Moo', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}