Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-25 @ 3:19 PM
Study NCT ID:
NCT05199168
Status:
UNKNOWN
Last Update Posted:
2022-06-01
First Post:
2022-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Visualization Versus Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerves During Thoracoscopic Esophagectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064795', 'term': 'Intraoperative Neurophysiological Monitoring'}], 'ancestors': [{'id': 'D016343', 'term': 'Monitoring, Intraoperative'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D064926', 'term': 'Neurophysiological Monitoring'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-30', 'studyFirstSubmitDate': '2022-01-05', 'studyFirstSubmitQcDate': '2022-01-14', 'lastUpdatePostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of the recurrent laryngeal nerve injury', 'timeFrame': 'Till 6 months postoperatively', 'description': 'The vocal cord function will be assessed by an experienced otolaryngologist using a laryngoscope on 1st postoperative day.RLN palsy will be classified according to the following variables: site (unilateral versus bilateral); duration (temporary \\[i.e., recovering within 6 months\\] versus permanent \\[i.e. not recovering within 6 months\\])postoperatively.'}], 'secondaryOutcomes': [{'measure': 'Number of nodes removed along the right and left RLN', 'timeFrame': 'The pathological analysis will be finished within 2 weeks.', 'description': 'number of lymph node removed'}, {'measure': 'Value of IONM during operation', 'timeFrame': '1 Day of surgery'}, {'measure': 'Post esophagectomy pneumonia rate', 'timeFrame': 'Duration of hospital stay, an expected average of 2~3 weeks.'}, {'measure': 'Operation time (thoracic phase)', 'timeFrame': 'Intraoperative'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Esophageal Cancer', 'Minimally invasive surgery', 'Recurrent laryngeal nerves', 'Intraoperative nerve monitoring'], 'conditions': ['Esophageal Cancer']}, 'descriptionModule': {'briefSummary': 'The clinical value of intraoperative nerve monitoring (IONM) in thoracoscopic esophagectomy remains uncertain. The aim of this randomized clinical trial was to compare the impact of RLN visualization versus IONM on their morbidity following thoracoscopic esophagectomy.', 'detailedDescription': 'Recurrent laryngeal nerves (RLN) lymph nodes are the most common metastatic areas in esophageal squamous carcinoma. It is a clinical challenge to reduce high incidence of RLN injury rate result from routine dissection of RLN lymph nodes. Thoracoscopic approach may provide a clear operative field and potentially less invasive surgery. But there are still high RLN injury rate only depending on visualization of thoracoscopy. The use of intraoperative nerve monitoring (IONM) was shown very helpful to identify the RLN and associated with a reduction of RLN injury rate in thyroidectomy. However, there is no solid clinical evidence about the effectiveness of utility of IONM in thoracoscopic esophagectomy. Thus, the aim of this randomized clinical trial was to compare the impact of RLN visualization versus IONM on their morbidity following thoracoscopic esophagectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically proven primary intrathoracic middle and lower esophageal squamous cell carcinoma and will undergo McKeown MIE and bilateral RLN lymph ndoe dissection.\n2. No superclavicular lymph node metastasis after preoperative examination.\n3. No contraindication for esophagectomy.\n4. Expected surgical R0 resection.\n\nExclusion Criteria:\n\n1. Pre-existed vocal cord dysfunction.\n2. Thorax pleural adhesion rendering minimal invasive approach unfeasible.\n3. Gastric tube cannot be used for reconstruction.\n4. Combined with hemorrhagic disease.\n5. Psychiatric patients.\n6. Inability to undergo curative resection and/or follow-up.'}, 'identificationModule': {'nctId': 'NCT05199168', 'briefTitle': 'Visualization Versus Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerves During Thoracoscopic Esophagectomy', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University Cancer Institute and Hospital'}, 'officialTitle': 'Randomized Clinical Trial of Visualization Versus Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerves During Thoracoscopic Esophagectomy', 'orgStudyIdInfo': {'id': 'E20210023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Thoracoscopic esophagectomy without IONM'}, {'type': 'EXPERIMENTAL', 'label': 'Thoracoscopic esophagectomy with IONM', 'description': 'Intraoperative bilateral recurrent laryngeal nerve monitoring was utilized during dissection of right and left recurrent laryngeal nerve lymph nodes.', 'interventionNames': ['Procedure: intraoperative nerve monitoring']}], 'interventions': [{'name': 'intraoperative nerve monitoring', 'type': 'PROCEDURE', 'description': 'Intraoperative bilateral recurrent laryngeal nerve monitoring was utilized during dissection of right and left recurrent laryngeal nerve lymph nodes.', 'armGroupLabels': ['Thoracoscopic esophagectomy with IONM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongjing Jiang, MD,PhD', 'role': 'CONTACT', 'email': 'jianghongjing@tmu.edu.cn', 'phone': '18622221069'}, {'name': 'Zhao Ma, MD,PhD', 'role': 'CONTACT', 'email': 'mazhao2015@163.com', 'phone': '15620610559'}], 'facility': 'Department of minimally invasive esophageal surgery, Tianjin Medical University Cancer Institute and Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Hongjing Jiang, MD. Ph.D.', 'role': 'CONTACT', 'email': 'jianghongjing@tmu.edu.cn', 'phone': '02223340123'}, {'name': 'Zhao Ma, MD. Ph.D.', 'role': 'CONTACT', 'email': 'mazhao2015@163.com', 'phone': '15620610559'}], 'overallOfficials': [{'name': 'Hongjing Jiang, MD. Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tianjin Medical University Cancer Institute and Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University Cancer Institute and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}