Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-31 @ 9:17 PM
Study NCT ID:
NCT01073358
Status:
UNKNOWN
Last Update Posted:
2017-10-27
First Post:
2010-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 166}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2010-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-26', 'studyFirstSubmitDate': '2010-02-22', 'studyFirstSubmitQcDate': '2010-02-22', 'lastUpdatePostDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of disease recurrence', 'timeFrame': '2 years after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['resectable hepatic metastases of colorectal cancer'], 'conditions': ['Hepatic Metastases', 'Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'It is uncertain, whether hilar lymphadenectomy should be performed routinely in patients undergoing resection of colorectal liver metastases.\n\nFor this reason it is the aim of the present prospective randomized trial to evaluate, if routine lymphadenectomy reduces recurrent disease in patients undergoing resection of colorectal liver metastases.', 'detailedDescription': 'Routine lymphadenectomy in patients undergoing hepatic resection for colorectal liver metastases may improve outcome of further patients due to the presence of micrometastases that have been shown to be of prognostic relevance. While previous studies highlight the clinical significance of perihepatic lymph node metastases, the outcome of patients with and without hilar lymphadenectomy has not yet been compared and thus no clear conclusion about the clinical value of routine hilar lymphadenectomy in CRC patients undergoing resection of liver metastases can be drawn from present data.\n\nAs disease recurrence occurs frequently and may affect up to 75 % of patients, further strategies are required to improve postoperative outcome. Routine hilar lymphadenectomy may offer an effective approach to remove residual disease and by this to reduce disease recurrence with little additional morbidity. For this reason it is the aim of the present prospective randomized trial to evaluate, if routine lymphadenectomy reduces recurrent disease in patients undergoing resection of colorectal liver metastases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for curative (R0) resection\n* No evidence of extrahepatic disease\n* No history of previous hepatic lymphadenectomy\n* Age equal or greater than 18 years\n* Written Informed consent\n\nExclusion Criteria:\n\n* Expected lack of compliance\n* Impaired mental state or language problems\n* History of another primary cancer, except:\n\n * Curatively treated in situ cervical cancer or curatively resected non-melanoma skin cancer\n * Other primary solid tumour curatively treated with no known active disease present and no treatment administered for ≥ 5 years prior to randomisation'}, 'identificationModule': {'nctId': 'NCT01073358', 'acronym': 'RELY', 'briefTitle': 'Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy - A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NNR-5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group A: No routine hilar lymphadenectomy', 'description': 'Resection of colorectal liver metastases without routine hilar lymphadenectomy'}, {'type': 'EXPERIMENTAL', 'label': 'Group B: Routine hilar lymphadenectomy', 'description': 'Hilar lymphadenectomy is performed before actual resection of the colorectal liver metastases.', 'interventionNames': ['Procedure: Routine hilar lymphadenectomy']}], 'interventions': [{'name': 'Routine hilar lymphadenectomy', 'type': 'PROCEDURE', 'description': 'Hilar lymphadenectomy is performed before actual resection of the colorectal liver metastases', 'armGroupLabels': ['Group B: Routine hilar lymphadenectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Department of Gastrointestinal, Thoracic and Vascular Surgery', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}], 'overallOfficials': [{'name': 'Jürgen Weitz, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Gastrointestinal, Thoracic and Vascular Surgery Dresden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD MD', 'investigatorFullName': 'Nuh Rahbari', 'investigatorAffiliation': 'University Hospital Carl Gustav Carus'}}}}