Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-28 @ 11:29 AM
Study NCT ID:
NCT04842968
Status:
COMPLETED
Last Update Posted:
2024-12-02
First Post:
2021-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ex Vivo Intraarterial Methylene Blue Injection Improve Nodal Staging Accuracy in Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008207', 'term': 'Lymphatic Metastasis'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008751', 'term': 'Methylene Blue'}], 'ancestors': [{'id': 'D010640', 'term': 'Phenothiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessor was blinded'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Five to six years ago specimens from a total fo 200 consecutive colorectal cancer resection cases were randomized into two groups: 1. main supplying artery was cannulated and injected with methylene blue solution, 2. no intervention, routine specimen handling.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-26', 'studyFirstSubmitDate': '2021-04-05', 'studyFirstSubmitQcDate': '2021-04-11', 'lastUpdatePostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total number of lymph nodes', 'timeFrame': 'Within 4 weeks after operation (at pathology work-up)', 'description': 'Total number of lymph nodes examined by pathologist'}, {'measure': 'Positive lymph nodes', 'timeFrame': 'Within 4 weeks after operation (at pathology work-up)', 'description': 'Number of positive lymph nodes found by pathologist'}, {'measure': 'Nodal staging accuracy', 'timeFrame': 'Within 4 weeks after operation (at pathology work-up)', 'description': 'Minimum Nr of 12 lymph nodes examined if reported N stage is N0, or positive lymph node=s) found'}, {'measure': 'At least 12 lymph nodes harvested', 'timeFrame': 'Within 4 weeks after operation (at pathology work-up)', 'description': 'Minimum Nr of 12 lymph nodes examined by pathologist'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '5 years (60 months) after operation', 'description': 'Overall survival after operation (in months)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colorectal', 'cancer', 'lymph', 'node', 'metastasis', 'methylene-blue'], 'conditions': ['Lymph Node Metastases', 'Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'Nodal staging holds both important prognostic and predictive value at colorectal cancer. Regional lymph nodes are located close to the primary tumor in the mesocolon / mesorectum. Current pathology and oncology standards require a separate examination of at least 12 lymph nodes each case to fulfill staging "accuracy" criteria.\n\nIn order to reach this number of lymph nodes, a precise surgical technique (total mesorectal excision or complete mesocolic excision), as well as a thorough pathological specimen work-up is needed.\n\nThe aim of the study is to investigate, if ex vivo intra-arterial methylene blue injection by the surgeon can help improving nodal harvesting effectivity of the pathologist, hence leading to a better staging and hopefully even to a better outcome in the long run.\n\nIn 2014-2015 two surgical centers randomised resected colorectal specimens in 1:1 ratio to methylene-blue injection arm and control (no injection) arm in a total of 200 consecutive cases. Both pathologic and oncologic treatment were led regardless of the injection, reports were just routinely saved in the routine medical documentation.\n\nThis retrospective study is designed to recall patient-related, surgery-related factors, as well as pathology reports including nodal staging from the medical databases. The investigators aim to find correlation between methylene blue "staining" and lymph node yield. In addition, the investigators plan to crossmatch methylene blue injection, as a process, with long term survival of the patients.', 'detailedDescription': 'Background:\n\nColorectal Cancer is the second most common cause of death in Hungary. The most important prognostic and predictive factor of colorectal cancer is the stage of disease at the time of diagnosis. Precise staging, especially nodal staging is highly important for correct planning of oncotherapy, i.e. adjuvant chemotherapy. Nodal staging relies on the proper surgical removal of mesocolon/mesorectum belonging to the the affected colorectal segment, as well as on the thorough pathology work-up of the specimen.\n\nCurrent quality standards require examination of a minimum of 12 lymph nodes in order to reliably report N0 stage.\n\nMethylene-blue injection into the main supplying artery of the removed specimen is one of the simplest and most effective techniques described to aid pathologist in lymph node harvesting.\n\nTechnique of methylene blue injection:\n\nFirst of all, surgeon need to en block remove the affected colorectal segment with its mesecolon/mesorectum. Then the surgeon isolates the main supplying artery and cannulated it with an appropriate-size canula.\n\nMethylene blue solution (50 mg methylene blue diluted in in 30 ml saline) is prepared and injected into the freshly removed specimen via the canula until the blue solution appears on the cut edges of the specimen.\n\nThe specimen can be processed in a routine way (placed in 4% formaldehyde).\n\nAim of the study:\n\nThe aim is to investigate if the well described and in Western-European healthcare systems well tested technique (Methylene blue injection) can be effectively adapted in an overwhelmed, busy Eastern-European healthcare environment. (Other techniques, including pathology assistant are not affordable in this area.) Apart form testing diagnostic accuracy of the pathologist on specimens with and without methylene blue injection, the investigators would like to assess a potential survival benefit of the suspected improvement of staging effectivity.\n\nTiming of the study:\n\nOver a 20-month period of 2014 and 2015 two surgical centers in Hungary randomised their elective colorectal resection cases into interventional and control arms. Randomisation was performed with a 1:1 ratio at each site on 100-100 consecutive cases.\n\nFurther pathology work-up and reporting has been routinely performed without any specific effect on oncology follow-up or treatment. No specific data collection has been performed after the intervention.\n\nThis study aims to retrospectively select the 100-100 (total of 200) consecutive colorectal resection cases of the given time frame from the official hospital medical recording systems.\n\nPathology reports and other relevant patient clinical records will be collected and statistically assessed.\n\nEthical approval was requested and gained from the Medical Research Council, Hungary, for the retrospective analysis of patient data.\n\nStatistical analysis:\n\nPower analysis was performed to get the sufficient number of cases (200 cases in total).\n\nCase Report Form The retrospectively included cases will be listed in a specific database on a safe medical server. Anthropometric, disease-specific, operation-specific and pathology report details will be extracted out of the official patient documentation system.\n\nPatients will be included according to the known interventional interval and the operation type (elective colorectal resection). Cases in the database will be anonymized. No patient-identifying data will be recorded or given to the assessor of the study (statistician).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective operation.\n* Colon or rectum resection performed.\n* Malignant colorectal condition.\n* Curative intent.\n\nExclusion Criteria:\n\n* Acute surgery performed\n* Final histology: benign\n* No other pathologic method (apart form Methylene Blue injection) used to improve lymph node yield'}, 'identificationModule': {'nctId': 'NCT04842968', 'acronym': 'MB', 'briefTitle': 'Ex Vivo Intraarterial Methylene Blue Injection Improve Nodal Staging Accuracy in Colorectal Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'St. Borbala Hospital'}, 'officialTitle': 'The Impact of ex Vivo Intra-arterial Methylene Blue Injection on Nodal Staging Accuracy and Survival in Colorectal Cancer.', 'orgStudyIdInfo': {'id': 'IV/3228/2021-EKU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methylene blue', 'description': 'Methylene blue solution (50 mg in 30 ml of saline solution) was injected in the cannulated main supplying artery of the freshly removed specimen, ex vivo. Colorectal specimen was then processed in the routine pathological work-up way.', 'interventionNames': ['Other: Methylene blue injection']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Colorectal specimens were processed in the routine pathological work-up way.'}], 'interventions': [{'name': 'Methylene blue injection', 'type': 'OTHER', 'description': 'Methylene blue solution is injected ex vivo in the main supplying artery trunk of the freshly removed colorectal specimen. (50 mg in 30 ml saline)', 'armGroupLabels': ['Methylene blue']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2800', 'city': 'Tatabánya', 'country': 'Hungary', 'facility': 'St. Borbala Hospital', 'geoPoint': {'lat': 47.59247, 'lon': 18.38099}}], 'overallOfficials': [{'name': 'Balazs Banky, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Borbala Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Borbala Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}