Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-28 @ 7:51 AM
Study NCT ID:
NCT04876235
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2021-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison Between Lumen-apposing Metal Stent and Double-pigtail Plastic Stents for Treatment of Walled-off Necrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D061765', 'term': 'Endoscopic Ultrasound-Guided Fine Needle Aspiration'}], 'ancestors': [{'id': 'D044963', 'term': 'Biopsy, Fine-Needle'}, {'id': 'D001707', 'term': 'Biopsy, Needle'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D061705', 'term': 'Image-Guided Biopsy'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D018084', 'term': 'Ultrasonography, Interventional'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-17', 'studyFirstSubmitDate': '2021-04-30', 'studyFirstSubmitQcDate': '2021-05-04', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical success (clinical improvement and resolution of WON)', 'timeFrame': 'two months', 'description': 'compare rates of WON resolution in patients with LAMS and DPPS for treatment of walled-off necrosis'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'two months', 'description': 'Number of participants with adverse events; type, frequency and intensity of adverse events'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endoscopic ultrasound guided drainage', 'Lumen-apposing metal stent', 'double-pigtail plastic stents', 'Walled-off necrosis'], 'conditions': ['Walled-off Necrosis']}, 'descriptionModule': {'briefSummary': 'Walled-off necrosis (WON) is defined as an encapsulated collection of solid and liquid necrotic material that is usually formed 4 weeks after an episode of acute necrotizing pancreatitis. As the advances in endoscopic techniques and accessories, Endoscopic ultrasound (EUS)-guided transluminal drainage has evolved to become the treatment of choice for symptomatic pancreatic walled-off necrosis (WON). This article aims to compare the efficacy and safety of a double mushroom head metal stent and a double pigtail plastic stent in the treatment of encapsulated necrosis of the pancreas.', 'detailedDescription': 'According to the revised Atlanta classification, pancreatic fluid collections (PFCs) include acute peripancreatic fluid collections(APFCs) and acute necrotic collections(ANCs), which, over time, turn into pancreatic pseudocysts (PPs) and walled-off pancreatic necrosis (WON). Drainage of these PP and WON is required when they increase in size and become infected or become symptomatic.\n\nTraditionally, WON has been managed surgically, however, surgical necrosectomy is associated with substantial morbidity and mortality, particularly when pursued early. In recent years, with the development of minimally invasive techniques, Endoscopic ultrasound (EUS)-guided transluminal drainage has evolved to become the treatment of choice for symptomatic pancreatic walled-off necrosis (WON).\n\nDouble-pigtail plastic stents(DPPS) is the earliest stent used for WON drainage in ultrasound endoscopy, however, These stents are limited by their small diameter leading to increased risk of stent obstruction. Recently, lumen-apposing metal stents (LAMS) have been increasingly used because of the advantage of better lumen apposition and wider diameter, improving access for endoscopic debridement. However, more adverse events(AEs) such as bleeding have been reported.\n\nThis article aims to compare the efficacy and safety of DPPS and LAMS in the treatment of Walled-off necrosis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obtention of a written informed consent\n* According to Revised Atlanta Classification, abdominal CT/MRI and EUS were diagnosed as WON\n* The diameter of WON ≥6cm\n* Patient capable of fill in the quality of life questionnaire\n* The distance between the EUS-probe and WON was \\< 1 cm.\n\nExclusion Criteria:\n\n* No written informed consent\n* pancreatic cystic tumor, pancreatic cancer and other benign and malignant tumors\n* pancreatic pseudocyst\n* WON too far from the stomach and duodenum to perform endoscopic drainage\n* Serious abnormalities in liver and kidney function and coagulation function\n* Pregnant, parturient or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT04876235', 'briefTitle': 'A Comparison Between Lumen-apposing Metal Stent and Double-pigtail Plastic Stents for Treatment of Walled-off Necrosis', 'organization': {'class': 'OTHER', 'fullName': "First People's Hospital of Hangzhou"}, 'officialTitle': 'Efficacy and Safety of Double-pigtail Plastic Versus Lumen-apposing Metal Stents for Transmural Drainage of Walled-off Necrosis', 'orgStudyIdInfo': {'id': '2021-03-221'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LAMS group', 'description': 'place LAMS under endoscopic ultrasound. Direct endoscopic necrosectomy(DEN) was performed through the LAMS with a forward viewing gastroscope if necessary', 'interventionNames': ['Procedure: endoscopic ultrasound', 'Device: lumen-apposing metal stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DPPS group', 'description': 'Place DPPS under endoscopic ultrasound. When required, DEN was performed once the cystogastrostomy/duodenostomy tract had matured. This was done by first removing the stents followed by dilation of the tract with a radial expansion balloon and insertion of a forward viewing gastroscope through the tract for DEN', 'interventionNames': ['Procedure: endoscopic ultrasound', 'Device: double-pigtail plastic stents']}], 'interventions': [{'name': 'endoscopic ultrasound', 'type': 'PROCEDURE', 'description': 'All patients were implanted with stents（DPPS or LAMS）under the EUS', 'armGroupLabels': ['DPPS group', 'LAMS group']}, {'name': 'lumen-apposing metal stent', 'type': 'DEVICE', 'description': 'In the LAMS group, patients were stented with LAMS', 'armGroupLabels': ['LAMS group']}, {'name': 'double-pigtail plastic stents', 'type': 'DEVICE', 'description': 'In the DPPS group, patients were stented with DPPS', 'armGroupLabels': ['DPPS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Jianfeng Yang', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Xiaofeng Zhang, M.S', 'role': 'STUDY_DIRECTOR', 'affiliation': "First People's Hospital of Hangzhou"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First People's Hospital of Hangzhou", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy irector', 'investigatorFullName': 'Jianfeng Yang', 'investigatorAffiliation': "First People's Hospital of Hangzhou"}}}}