Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-25 @ 2:44 PM
Study NCT ID:
NCT07253350
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-28
First Post:
2025-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Endorotor PED® System Versus Conventional Endoscopic Techniques for the Management of Walled-off Pancreatic Necrosis in Acute Necrotizing Pancreatitis: Randomized Single-blinded Controlled Superiority Trial and Cost-utility Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019283', 'term': 'Pancreatitis, Acute Necrotizing'}], 'ancestors': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2025-11-19', 'studyFirstSubmitQcDate': '2025-11-19', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluate the effectiveness of the Endorotor PED® device versus conventional technique for the endoscopic management of symptomatic walled-off necrosis during necrotizing acute pancreatitis.', 'timeFrame': '5 month', 'description': 'The effectiveness of the operative approach (Endorotor 3.2/PED® or conventional technique) will be assessed by the period in days between the first DEN session and the confirmed complete necrosis resolution.'}], 'secondaryOutcomes': [{'measure': 'number of death', 'timeFrame': '10 month'}, {'measure': 'number of new-onset multiple organ failure', 'timeFrame': '10 month'}, {'measure': 'number of visceral perforation', 'timeFrame': '10 month'}, {'measure': 'number of arterial perforation', 'timeFrame': '10 month'}, {'measure': 'number of pancreatic-cutaneous fistulas', 'timeFrame': '10 month'}, {'measure': 'number of sepsis', 'timeFrame': '10 month'}, {'measure': 'number of abscess', 'timeFrame': '4 month'}, {'measure': 'number of Bleeding of any severity', 'timeFrame': '4 month'}, {'measure': 'number of Need for surgery (video-assisted retroperitoneal debridement or open surgery)', 'timeFrame': '4 month'}, {'measure': 'number of Need for "multigate" strategy with the installation of a percutaneous drain', 'timeFrame': '4 month'}, {'measure': 'time to total recovery of acute pancreatitis', 'timeFrame': '16 month'}, {'measure': 'Total time of all DEN sessions in minutes', 'timeFrame': '4 month'}, {'measure': 'Total number of DEN sessions', 'timeFrame': '4 month'}, {'measure': 'Number of days of antibiotic treatment', 'timeFrame': '4 month'}, {'measure': 'operative difficulty of DEN assessed by endoscopists', 'timeFrame': '4 month', 'description': 'A Likert score will be used to assess the ease of use to maneuver device by endoscopist, from 0 (most difficult surgery imaginable) to 10 (easiest).'}, {'measure': 'number of issues with Endorotor PED® device', 'timeFrame': '4 month', 'description': 'Failure types and number of occurrences'}, {'measure': 'Number of days of hospitalization: In intensive care unit', 'timeFrame': '16 month'}, {'measure': 'Number of days of hospitalization: In conventional unit', 'timeFrame': '16 month'}, {'measure': 'Number of days of hospitalization in rehabilitation unit', 'timeFrame': '16 month'}, {'measure': 'quality of life of patients during and after hospitalization', 'timeFrame': '16 month', 'description': "EQ-5D-5L score at the end of hospitalization and during follow-up's visits"}, {'measure': 'Total hospital costs in acute care per patient Endorotor', 'timeFrame': '16 month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endoscopic necrosectomy', 'necrotic pancreatic collection'], 'conditions': ['Acute Necrotizing Pancreatitis']}, 'descriptionModule': {'briefSummary': 'This is a national single-blinded prospective multicenter randomized (1:1) controlled trial, with two parallel arms, using a PROBE methodology, including patients with complicated acute necrotizing pancreatitis who require DEN of WON collection after endoscopic drainage. We will compare 2 groups: conventional DEN and DEN with Endorotor®. The study will be offered to all consecutive patients fulfilling the eligibility criteria after endoscopic drainage for WON. Since the time between drainage and the first necrosectomy session is usually at least 48 hours a period of at least 24h will be allowed for the patient to consider options to participate or not. Information and collection of informed consent will be done by an investigating physician.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age≥18years\n* ASA\\<5\n* CT scan less than 7 days old\n* Hospitalized for acute necrotizing pancreatitis, whatever the cause, and who have undergone drainage of pancreatic collections for the following indications according to the revised Atlanta criteria (infection, organ compression, persistent organ failure)\n* Have need for at least one DEN session despite endoscopic drainage (persistence of clinical symptoms or sepsis \\>48h after drainage with collection still visible)\n\nExclusion Criteria:\n\n* No endoscopic drainage in place for the management of WON\n* Have already had a DEN session (endoscopic or else) before screening for inclusion\n* Life-expectancy \\< 1year (advanced cancer, etc)\n* Known haemostasis disorder (chronic thrombocytopenia, haemophilia, etc.)\n* Pregnant or breastfeeding woman\n* Subject deprived of freedom, subject under a legal protective measure\n* Non-affiliation to a social security regimen or CMU\n* Patient or person of confidence (if present at the time of inclusion) opposing the patient's participation in research\n* Subject already involved in another interventional clinical research"}, 'identificationModule': {'nctId': 'NCT07253350', 'acronym': 'ROTONEC', 'briefTitle': 'Effectiveness of Endorotor PED® System Versus Conventional Endoscopic Techniques for the Management of Walled-off Pancreatic Necrosis in Acute Necrotizing Pancreatitis: Randomized Single-blinded Controlled Superiority Trial and Cost-utility Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Effectiveness of Endorotor PED® System Versus Conventional Endoscopic Techniques for the Management of Walled-off Pancreatic Necrosis in Acute Necrotizing Pancreatitis: Randomized Single-blinded Controlled Superiority Trial and Cost-utility Analysis', 'orgStudyIdInfo': {'id': 'APHP230816'}, 'secondaryIdInfos': [{'id': 'ID-RCB', 'type': 'OTHER', 'domain': '2024-A01139-38'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endorotor Group', 'description': 'DEN will be performed with Endorotor 3.2 or ENDOROTOR PED® system depending on the position of cystoenterostomy.', 'interventionNames': ['Device: Endorotor Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional group', 'description': 'DEN is performed conventionally with abundant lavage and mechanical debridement using a non-dedicated material (diathermic loop, polypectomy or Dormia basket) to catch pieces of necrosis', 'interventionNames': ['Other: Conventional group']}], 'interventions': [{'name': 'Endorotor Group', 'type': 'DEVICE', 'description': 'DEN will be performed with Endorotor 3.2 or ENDOROTOR PED® system depending on the position of cystoenterostomy. Endorotor 3.2 is slimmer and enters WON more easily when the transgastric access is located in the upper portion of the stomach). If needed: lavage, aspiration and conventional mechanical debridement could be used in addition during an ENDOROTOR-based DEN session.', 'armGroupLabels': ['Endorotor Group']}, {'name': 'Conventional group', 'type': 'OTHER', 'description': 'DEN is performed conventionally with abundant lavage and mechanical debridement using a non-dedicated material (diathermic loop, polypectomy or Dormia basket) to catch pieces of necrosis', 'armGroupLabels': ['Conventional group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Clichy', 'country': 'France', 'contacts': [{'name': 'Frederic Prat, MD PHD', 'role': 'CONTACT', 'email': 'frederic.prat@aphp.fr', 'phone': '01 40 87 56 63', 'phoneExt': '+33'}], 'facility': 'Hospital Beaujon, APHP', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}], 'centralContacts': [{'name': 'Frederic Prat, MD PHD', 'role': 'CONTACT', 'email': 'frederic.prat@aphp.fr', 'phone': '01 40 87 56 63', 'phoneExt': '+33'}, {'name': 'Diane Lorenzo, MD PHD', 'role': 'CONTACT', 'email': 'diane.lorenzo@gmail.com', 'phone': '01 40 87 56 63', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'frederic Prat, MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'APHP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}