Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT03027895
Status:
UNKNOWN
Last Update Posted:
2018-03-30
First Post:
2017-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010192', 'term': 'Pancreatic Pseudocyst'}], 'ancestors': [{'id': 'D010181', 'term': 'Pancreatic Cyst'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 256}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-28', 'studyFirstSubmitDate': '2017-01-14', 'studyFirstSubmitQcDate': '2017-01-20', 'lastUpdatePostDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical success', 'timeFrame': 'uo to 1 months', 'description': 'The cysts completely disappeared, or diameter ≤ 2cm in the imaging follow-up symptoms have eased'}], 'secondaryOutcomes': [{'measure': 'adverse event', 'timeFrame': 'up to 2months/ stent remove', 'description': 'any adverse event occured after stent inserted'}, {'measure': 'recurrence rate', 'timeFrame': 'up to 12 months', 'description': 'After the clinical success, imaging examination show cyst again and accompanied by symptoms'}, {'measure': 'technical success', 'timeFrame': 'up to 48 hours', 'description': 'Stent placed through the wall bracket and pancreatic pseudocyst successfully'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Pseudocyst']}, 'referencesModule': {'references': [{'pmid': '30305160', 'type': 'DERIVED', 'citation': 'Zhu HY, Xie P, Song YX, Li ZS, Jin ZD, Du YQ. Lumen-apposing metal stents (LAMS) versus plastic stents for EUS-guided drainage of walled-off necrosis (WON) (LVPWON): study protocol for a multicenter randomized controlled trial. Trials. 2018 Oct 11;19(1):549. doi: 10.1186/s13063-018-2901-3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and double pigtail plastic stents (DPPSs) on the drainage of pancreatic walled-off necrosis (WON), mainly to observe the efficacy and safety of LAMS for WON.', 'detailedDescription': 'Patient with pancreatic walled-off necrosis (WON) would be treated randomized with lumen-apposing metal stent (LAMS) or double pigtail plastic stents (DPPSs) under the guidance of Endoscopic Ultrasonography. The investigators compare the effect of the two stents, including technical success, clinical success, adverse event, recurrence, and so on.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject with ages from 18-80 years old\n2. Subject with pancreatic pseudocysts confirmed by CT\n3. Subject with a history of MSAP or SAP, the pseudocysts were formed more than 3 months\n4. The size of pseudocyst is more than 6 cm, and the cyst adjacent to the gastric wall\n5. Subject has the symptoms related with the pseudocyst\n6. The consent form has been signed\n\nExclusion Criteria:\n\n1. Subject is younger than 18 years or older than 80 years\n2. Pancreatic pseudocyst communicate with the main pancreatic duct\n3. Subject can't accept the endoscopic procedure\n4. Pancreatic pseudocyst with infection or subject diagnosed with pancreatic abscess\n5. The distance between gastric and the wall of the pseudocyst is more than 1 cm\n6. Subject with 2 or more than 2 cysts\n7. Subject has blood coagulation dysfunction\n8. Pregnant or subject has mental disorders"}, 'identificationModule': {'nctId': 'NCT03027895', 'briefTitle': 'Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)', 'orgStudyIdInfo': {'id': '2017010302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lumen-apposing metal stent(LAMS)', 'description': 'Lumen-apposing metal stent(LAMS) will be deployed by endoscopist under the guidance of EUS', 'interventionNames': ['Device: Lumen-apposing metal stent (LAMS)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Double pigtail plastic stent(DPPS)', 'description': 'Double pigtail plastic stent(DPPS) will be deployed by endoscopist under the guidance of EUS', 'interventionNames': ['Device: Double pigtail plastic stent (DPPS)']}], 'interventions': [{'name': 'Lumen-apposing metal stent (LAMS)', 'type': 'DEVICE', 'description': 'Endoscopic Ultrasound-guided Drainage of WON with LAMS', 'armGroupLabels': ['Lumen-apposing metal stent(LAMS)']}, {'name': 'Double pigtail plastic stent (DPPS)', 'type': 'DEVICE', 'description': 'Endoscopic Ultrasound-guided Drainage of WON with DPPS', 'armGroupLabels': ['Double pigtail plastic stent(DPPS)']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yiqi Du', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yiqi Du', 'investigatorAffiliation': 'Changhai Hospital'}}}}