Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-30 @ 12:28 PM
Study NCT ID:
NCT05867095
Status:
COMPLETED
Last Update Posted:
2023-05-19
First Post:
2022-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Navigated Abdominal Lymph Node Dissections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008207', 'term': 'Lymphatic Metastasis'}], 'ancestors': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D025321', 'term': 'Surgery, Computer-Assisted'}, {'id': 'D003226', 'term': 'Congresses as Topic'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-17', 'studyFirstSubmitDate': '2022-11-09', 'studyFirstSubmitQcDate': '2023-05-17', 'lastUpdatePostDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of failed procedures', 'timeFrame': '3 months', 'description': 'Failed procedure is defined as: presence of any residual target lymph node on follow-up imaging'}], 'secondaryOutcomes': [{'measure': 'Surgical time to remove lymph node', 'timeFrame': 'After surgery', 'description': 'time from having the surgical field prepared for lymph node localization to actual removal of the lymph node, overall surgical time,'}, {'measure': 'LN success', 'timeFrame': '3 months', 'description': 'individual LN retrieval rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Image-guide Surgery', 'Lymph Node Metastasis']}, 'referencesModule': {'references': [{'pmid': '39737148', 'type': 'DERIVED', 'citation': 'Groen HC, Wit EMK, Heerink WJ, Kuhlmann KFD, Nijkamp JA, van Veen R, Schoots IG, Balduzzi S, Zijlmans HJMAA, van Leeuwen PJ, van der Poel HG, Ruers TJM. Surgical navigation for targeted retroperitoneal lymph-node removal: a randomised, controlled, phase 3 trial. EClinicalMedicine. 2024 Jul 26;74:102754. doi: 10.1016/j.eclinm.2024.102754. eCollection 2024 Aug.'}]}, 'descriptionModule': {'briefSummary': 'Image-guided navigation surgery allows for full utilization of pre-operative imaging during surgery, and has the potential of reducing both irradical resections and morbidity. In this study we will randomize patients which will undergo an abdominal lymph node dissection in order to evaluate the actual technical and clinical benefit of navigation', 'detailedDescription': 'In the study patients will be randomized between the use of a surgical navigation system or not. The operation itself will be performed according to current clinical practice, and the navigation system will be used for better localization and orientation during the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for open abdominal surgery in which targeted removal of one or more pathological lymph nodes is part of the surgical plan\n\nExclusion Criteria:\n\n* Metal implants in the pelvic area\n* Contra-indication for contrast enhanced CT scanning'}, 'identificationModule': {'nctId': 'NCT05867095', 'acronym': 'N16LND', 'briefTitle': 'Navigated Abdominal Lymph Node Dissections', 'organization': {'class': 'OTHER', 'fullName': 'The Netherlands Cancer Institute'}, 'officialTitle': 'Targeted Abdominal Lymph nodE Dissections Randomized for Surgical NavigaTion (TALENT)', 'orgStudyIdInfo': {'id': 'N16LND'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Navigation', 'description': 'Patients will get the standard of care in the Netherlands with the addition of surgical navigation', 'interventionNames': ['Procedure: Surgical navigation']}, {'type': 'OTHER', 'label': 'Conventional', 'description': 'Patients will get the standard of care in the Netherlands', 'interventionNames': ['Procedure: Conventional']}], 'interventions': [{'name': 'Surgical navigation', 'type': 'PROCEDURE', 'description': 'Patients will be operated with assistance of a navigation system', 'armGroupLabels': ['Navigation']}, {'name': 'Conventional', 'type': 'PROCEDURE', 'description': 'Patients will be operated using the conventional technique', 'armGroupLabels': ['Conventional']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1066 CX', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Netherlands Cancer Institute', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Netherlands Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}