Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-03-27 @ 8:44 AM
Study NCT ID:
NCT02269020
Status:
COMPLETED
Last Update Posted:
2019-01-11
First Post:
2014-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neck Dissection Via a Robot-assisted Transaxillary Approach in Patients With Squamous Cell Carcinoma of the Epi-larynx
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D037981', 'term': 'Neck Dissection'}], 'ancestors': [{'id': 'D008197', 'term': 'Lymph Node Excision'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013517', 'term': 'Otorhinolaryngologic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-10', 'studyFirstSubmitDate': '2014-10-08', 'studyFirstSubmitQcDate': '2014-10-17', 'lastUpdatePostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The number of ganglions excised at each level.', 'timeFrame': 'expected between day 7 and day 15'}, {'measure': 'The number of metastatic ganglions', 'timeFrame': 'expected between day 7 and day 15'}, {'measure': 'The presence/absence of capsular rupture', 'timeFrame': 'expected between day 7 and day 15'}, {'measure': 'Normal functioning of cranial nerve IX: yes/no.', 'timeFrame': 'Day 15'}, {'measure': 'Normal functioning of cranial nerve X: yes/no.', 'timeFrame': 'Day 15'}, {'measure': 'Normal functioning of cranial nerve XI: yes/no.', 'timeFrame': 'Day 15'}, {'measure': 'Normal functioning of cranial nerve XII: yes/no.', 'timeFrame': 'Day 15'}, {'measure': 'Normal functioning of the brachial plexus nerve: yes/no.', 'timeFrame': 'Day 15'}, {'measure': 'Normal functioning of the cervical sympathetic nerve: yes/no.', 'timeFrame': 'Day 15'}, {'measure': 'Normal functioning of cranial nerve IX: yes/no.', 'timeFrame': 'Month 6'}, {'measure': 'Normal functioning of cranial nerve X: yes/no.', 'timeFrame': 'Month 6'}, {'measure': 'Normal functioning of cranial nerve XI: yes/no.', 'timeFrame': 'Month 6'}, {'measure': 'Normal functioning of cranial nerve XII: yes/no.', 'timeFrame': 'Month 6'}, {'measure': 'Normal functioning of the brachial plexus nerve: yes/no.', 'timeFrame': 'Month 6'}, {'measure': 'Normal functioning of the cervial sympathetic nerve: yes/no.', 'timeFrame': 'Month 6'}, {'measure': 'Normal functioning of cranial nerve IX: yes/no.', 'timeFrame': 'Month 12'}, {'measure': 'Normal functioning of cranial nerve X: yes/no.', 'timeFrame': 'Month 12'}, {'measure': 'Normal functioning of cranial nerve XI: yes/no.', 'timeFrame': 'Month 12'}, {'measure': 'Normal functioning of cranial nerve XII: yes/no.', 'timeFrame': 'Month 12'}, {'measure': 'Normal functioning of the brachial plexus nerve: yes/no.', 'timeFrame': 'Month 12'}, {'measure': 'Normal functioning of the cervical sympathetic nerve: yes/no.', 'timeFrame': 'Month 12'}, {'measure': 'Presence/absence of intraoperative complications', 'timeFrame': 'Day 0'}, {'measure': 'Presence / absence of complications during the hospitalization period', 'timeFrame': 'estimated max of 6 days'}, {'measure': 'Presence / absence of complications at the post-operative follow-up visit', 'timeFrame': 'day 7 to day 15'}, {'measure': 'Analgesic consumption', 'timeFrame': 'During hospitalization; expected max of 6 days', 'description': 'Qualitative: Level I, Level II, Level III.'}, {'measure': 'Analgesic consumption', 'timeFrame': 'days 7 to 15', 'description': 'Qualitative: Level I, Level II, Level III.'}, {'measure': 'Analgesic consumption', 'timeFrame': 'month 6', 'description': 'Qualitative: Level I, Level II, Level III.'}, {'measure': 'Daily visual analog scale for pain', 'timeFrame': 'During hospitalization; expected max of 6 days.'}, {'measure': 'Visual analog scale for pain', 'timeFrame': 'days 7 to 15'}, {'measure': 'Visual analog scale for pain', 'timeFrame': 'month 6'}, {'measure': 'Visual analog scale for pain', 'timeFrame': 'month 12'}, {'measure': 'Length of axillary scar', 'timeFrame': 'day 0'}, {'measure': 'Length of thoracic scar', 'timeFrame': 'day 0'}, {'measure': 'Length of axillary scar', 'timeFrame': 'month 6'}, {'measure': 'Length of thoracic scar', 'timeFrame': 'month 6'}, {'measure': 'Length of axillary scar', 'timeFrame': 'month 12'}, {'measure': 'Length of thoracic scar', 'timeFrame': 'month 12'}, {'measure': 'Patient satisfaction concerning his/her scar', 'timeFrame': 'month 6', 'description': 'visual analog scale from 0 to 10'}, {'measure': 'Patient satisfaction concerning his/her scar', 'timeFrame': 'month 12', 'description': 'visual analog scale from 0 to 10'}, {'measure': 'Oncological results', 'timeFrame': 'month 6', 'description': 'Qualitative variable: (A) Living with disease progression, if so: (i) Recurrence: yes / no; (ii) Metastases: yes / no. or (B) Living without recurrence or (C) Deceased; give causes.'}, {'measure': 'Oncological results', 'timeFrame': 'month 12', 'description': 'Qualitative variable: (A) Living with disease progression, if so: (i) Recurrence: yes / no; (ii) Metastases: yes / no. or (B) Living without recurrence or (C) Deceased; give causes.'}], 'primaryOutcomes': [{'measure': 'Number of patients that had pre-defined key points of the surgical procedure performed', 'timeFrame': 'Day 0', 'description': 'Were all pre-defined key points of the surgical procedure performed? yes/no Description of the key points (includes (i) axillary approach, (ii) robot arm insertion, (iii) dissection, (iv) closing) of the surgical procedure.'}, {'measure': 'Number of lymph nodes dissected', 'timeFrame': 'Day 0', 'description': 'Determined by analysis of excised tissues.'}], 'secondaryOutcomes': [{'measure': 'The duration of surgical site preparation', 'timeFrame': 'Day 0', 'description': 'in minutes'}, {'measure': 'The duration of robot installation / preparation', 'timeFrame': 'Day O', 'description': 'in minutes'}, {'measure': 'Intervention time (between incision and closure by the surgeon)', 'timeFrame': 'Day 0', 'description': 'in minutes'}, {'measure': 'Time in general anesthesia', 'timeFrame': 'Day 0', 'description': 'in minutes'}, {'measure': 'Surgical time (console time for robot-assisted surgery)', 'timeFrame': 'Day 0', 'description': 'in minutes'}, {'measure': 'The estimated volume of bleeding', 'timeFrame': 'Day 0', 'description': 'in ml'}, {'measure': 'Need for conversion to open surgery', 'timeFrame': 'Day 0', 'description': 'yes/no'}, {'measure': 'The anesthesia protocol used', 'timeFrame': 'Day 0', 'description': 'Full description.'}, {'measure': 'The level of difficulty associated with each surgical step', 'timeFrame': 'Day 0', 'description': 'Qualitative: easy, medium, hard, extremely hard'}, {'measure': 'The level of speed associated with each surgical step', 'timeFrame': 'Day 0', 'description': 'Qualitative: slow, normal, fast'}, {'measure': 'Length of hospital stay in days', 'timeFrame': 'estimated max of 6 days'}, {'measure': 'Results of pathological analysis of lymph nodes', 'timeFrame': 'expected between day 7 and day 15'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Squamous Cell Carcinoma of the Epi-larynx'], 'conditions': ['Carcinoma, Squamous Cell']}, 'descriptionModule': {'briefSummary': 'The main hypothesis of this study is that it is possible to make a unilateral selective dissection of ganglion levels IIa, III and IV using an endoscopic transaxillary approach via the da Vinci robotic system to reduce scarring, while respecting patient safety.\n\nFeasibility will be assessed by two combinded criteria: 1) performance of the surgical procedure respecting the different stages of visualization and dissection of key anatomical elements; 2) obtain a minimum of 9 lymph nodes when analyzing pathological evidence of the dissection.', 'detailedDescription': 'Secondary objectives include the following:\n\nA. Describe certain technical variables: surgical time, extent of blood loss, need for conversion to open surgery, anesthesia procedure used, the level of difficulty and speed associated with each surgical step, length of stay, B. Describe the pathological findings for each patient, C. Evaluate neurological complications (function of cranial nerve pairs X, XI, XII, brachial plexus, cervical sympathetic) D. Identify specific complications, E. Evaluate post-operative pain, F. Evaluate the scar outcome at 6 and 12 months G. Describe the oncological results at 6 and 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cancer of the epi-larynx: (i) ranked T1 or T2 in the TNM classification, (ii) supraglottic or glotto-supraglottic location, (iii) CN0 nodal status\n* Absence of distant metastasis (M0)\n* Decision for unilateral endoscopic axillary neck dissection at lymph node levels IIa, III and IV of the Robins classification is retained in a multidisciplinary meeting\n* The patient is available for 12 months of follow-up\n* The patient must have given his/her informed and signed consent\n* The patient must be insured or beneficiary of a health insurance plan\n\nExclusion Criteria:\n\n* Patient participating in or having participated in another study within the previous 3 months or currently in an exclusion period determined by a previous study\n* Adult under judicial protection or any kind of guardianship\n* Refusal to sign the consent\n* It is impossible to correctly inform the patient\n* The patient is pregnant, parturient, or breastfeeding\n* Preoperative diagnosis of a second location of cancerous disease\n* Body Mass Index \\> 25\n* History of cervical spine surgery\n* History of instability of the cervical spine\n* History of surgery in the shoulder or pre-pectoral region\n* History of ipsilateral neck surgery\n* History of cervical radiotherapy\n* History of breast implants'}, 'identificationModule': {'nctId': 'NCT02269020', 'acronym': 'RoboCurage ORL', 'briefTitle': 'Neck Dissection Via a Robot-assisted Transaxillary Approach in Patients With Squamous Cell Carcinoma of the Epi-larynx', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Unilateral Selective Neck Dissection at Lymph Node Levels IIa, III and IV Using a Robot-assisted Transaxillary Approach in Patients With Squamous Cell Carcinoma of the Epi-larynx: the First Three Patients', 'orgStudyIdInfo': {'id': 'LOCAL/2013/BL-01'}, 'secondaryIdInfos': [{'id': '2014-A00117-40', 'type': 'OTHER', 'domain': 'RCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3 patients cancer of the epi larynx', 'description': '3 patients with squamous cell carcinoma of the epi-larynx\n\nIntervention: Neck Dissection', 'interventionNames': ['Procedure: Neck Dissection']}], 'interventions': [{'name': 'Neck Dissection', 'type': 'PROCEDURE', 'description': 'Unilateral Selective Neck Dissection at Lymph Node Levels IIa, III and IV Using a Robot-assisted Transaxillary Approach. The robotic system used is the da Vinci system.', 'armGroupLabels': ['3 patients cancer of the epi larynx']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHRU de Nîmes - Hôpital Universitaire Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Benjamin Lallemant, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}