Ignite Creation Date:
2025-12-24 @ 4:22 PM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT07182266
Status:
COMPLETED
Last Update Posted:
2025-09-19
First Post:
2025-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Outcomes and Survival of Inflatable Video-Assisted Mediastinoscopic Transhiatal Esophagectomy for Selected Esophageal Cancer
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1661}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2025-09-11', 'studyFirstSubmitQcDate': '2025-09-11', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'within 2 years after surgery', 'description': 'Disease-Free Survival, Overall Survival'}, {'measure': 'Complication', 'timeFrame': 'perioperative', 'description': 'follow the guidelines of the Esophageal Complications Consensus Group (ECCG) recommendations and Clavien-Dindo classification'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['esophageal carcinoma', 'mediastinoscopic', 'McKeown'], 'conditions': ['Esophageal Carcinoma']}, 'descriptionModule': {'briefSummary': 'Perioperative and oncologic benefits of inflatable video-assisted mediastinoscopic transhiatal esophagectomy (IVMTE) are unclear. This retrospective study aimed to compare the differences in perioperative outcomes and survival between IVMTE and video-assisted McKeown esophagectomy (VME).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'From January 2021 to December 2023, patients with esophageal cancer who received IVMTE or VME were identified from the prospectively maintained esophageal cancer database at Zhongshan Hospital, Fudan University', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n(I) primary esophageal cancer confirmed by endoscopic biopsy and (II) diagnosed resectable tumors based on positron emission tomography-computed tomography (PET-CT) according to the International Union Against Cancer Tumor, Node, Metastasis (TNM) Classification (8th edition)\n\nExclusion Criteria:\n\n(I) presence of other advanced malignancies, (II) insufficient clinical data, or (III) postoperative follow-up of less than 12 months.'}, 'identificationModule': {'nctId': 'NCT07182266', 'briefTitle': 'Perioperative Outcomes and Survival of Inflatable Video-Assisted Mediastinoscopic Transhiatal Esophagectomy for Selected Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Perioperative Outcomes and Survival of Inflatable Video-Assisted Mediastinoscopic Transhiatal Esophagectomy for Selected Esophageal Cancer: A Comparative Study With Propensity-Score Matching Analysis', 'orgStudyIdInfo': {'id': 'B2024-122R'}, 'secondaryIdInfos': [{'id': '20ZR1411600', 'type': 'OTHER_GRANT', 'domain': 'Science and Technology Commission of Shanghai Municipality'}, {'id': 'SHDC2020CR4039', 'type': 'OTHER_GRANT', 'domain': 'Shanghai Hospital Development Center'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'IVMTE', 'description': 'The patient was positioned supine. A 5-cm cervical incision was made along the anterior border of the left sternocleidomastoid muscle as the main surgical route. The skin and subcutaneous tissues were carefully incised in layers. The left recurrent laryngeal nerve (RLN) was identified and traced, followed by mobilization of the cervical esophagus. A lap protector was inserted into the left incision to create a closed cavity, and the mediastinum was insufflated with carbon dioxide at 8 mmHg. Three 5-mm trocars were used for the specialized retractor, LigaSure Maryland jaw sealer, and mediastinoscope. Then, the esophagus was dissected up to the level of the carina or the inferior pulmonary vein. During this process, mediastinal lymph nodes were also removed, including bilateral RLN, paraesophageal, tracheobronchial, and subcarinal nodes. If necessary, the incision was then extended to the right neck to facilitate the dissection of the right cervical lymph nodes.'}, {'label': 'VME', 'description': 'traditional video-assisted McKeown esophagectomy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'A data sharing plan is under consideration but must first be reviewed and approved by our ethics committee to ensure full compliance with participant confidentiality agreements.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}