Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-03-15 @ 9:23 AM
Study NCT ID:
NCT07004634
Status:
RECRUITING
Last Update Posted:
2025-06-10
First Post:
2025-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Drainage Methods in Minimally Invasive Esophagectomy (DEMURE）
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], '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'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015505', 'term': 'Chest Tubes'}], 'ancestors': [{'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2025-05-05', 'studyFirstSubmitQcDate': '2025-05-26', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Pain Scores', 'timeFrame': 'Pain scores were recorded at different times during the postoperative period when the patients were quiet and active (at 7 AM, 11 AM, 3 PM, and 7 PM) from postoperative day 1 to postoperative day 4.', 'description': 'Pain scores were assessed based on the visual analog scale according to the World Health Organization guidelines, in which 0 indicated no pain and 10 indicated the worst possible pain.\n\nWe also recorded and evaluated maximum daily pain scores when pain caused by the mediastinal drainage tube incision.'}], 'secondaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': 'Postoperative complications from posoperative day 1 to postoperative month 3', 'description': 'Postoperative complications included anastomotic leak, major pulmonary complications, and major abdominal complications. Pleural effusion was defined as a drainage volume of greater than 800 mL. Pneumothorax was defined by a distance of greater than 3 cm between the apex of the lung and the top of the ribcage on chest radiography.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Esophageal cancer', 'Mediastinal drainage tube', 'Postoperative pain'], 'conditions': ['Esophageal Cancer', 'Drainage/Methods', 'Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'This RCT compares three drainage approaches after minimally invasive esophagectomy (chest tube + thoracic mediastinal drainage tube, thoracic, and abdominal mediastinal drainage tube) to evaluate perioperative outcomes, addressing current evidence gaps in pain and complication profiles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Pathologically confirmed esophageal cancer requiring three-incision esophagectomy (cervical, thoracic, and abdominal incisions)\n* ASA physical status class I-III\n\nExclusion Criteria:\n\n* History of chronic pain or long-term use of analgesics prior to surgery\n* Severe cardiopulmonary dysfunction (e.g., FEV1 \\<50%)\n* Coagulation disorders or patients undergoing reoperation\n* Intraoperative findings of extensive pleural adhesions, combined resection of adjacent organs, or other conditions deemed by the investigator to warrant exclusion'}, 'identificationModule': {'nctId': 'NCT07004634', 'briefTitle': 'Comparison of Drainage Methods in Minimally Invasive Esophagectomy (DEMURE）', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Comparison of the Application Effects of Different Drainage Modes in the Perioperative Period of Minimally Invasive Three-Field Radical Esophagectomy for Esophageal Cancer', 'orgStudyIdInfo': {'id': 'RTS-026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Abdominal mediastinal tube', 'description': 'Transperitoneal mediastinal drainage was performed for postoperative management of the patient.', 'interventionNames': ['Procedure: Abdominal mediastinal tube']}, {'type': 'EXPERIMENTAL', 'label': 'Chest mediastinal tube', 'description': 'Transthoracic mediastinal drainage was performed for postoperative management of the patient.', 'interventionNames': ['Procedure: Chest mediastinal tube']}, {'type': 'EXPERIMENTAL', 'label': 'Chest tube + chest mediastinal tube', 'description': 'Chest tube insertion combined with transthoracic mediastinal drainage was performed for postoperative management of the patient.', 'interventionNames': ['Procedure: Chest tube + chest mediastinal tube']}], 'interventions': [{'name': 'Chest mediastinal tube', 'type': 'PROCEDURE', 'description': 'Transthoracic mediastinal drainage was performed for postoperative management of the patient.', 'armGroupLabels': ['Chest mediastinal tube']}, {'name': 'Abdominal mediastinal tube', 'type': 'PROCEDURE', 'description': 'Transperitoneal mediastinal drainage was performed for postoperative management of the patient.', 'armGroupLabels': ['Abdominal mediastinal tube']}, {'name': 'Chest tube + chest mediastinal tube', 'type': 'PROCEDURE', 'description': 'Chest tube insertion combined with transthoracic mediastinal drainage was performed for postoperative management of the patient.', 'armGroupLabels': ['Chest tube + chest mediastinal tube']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dingpei Han, PhD, MD', 'role': 'CONTACT', 'email': 'dmhan1985@163.com', 'phone': '00862164370045', 'phoneExt': '666112'}], 'facility': 'Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Hecheng Li, PhD, MD', 'role': 'CONTACT', 'email': 'lihecheng2000@hotmail.com', 'phone': '00862164370045', 'phoneExt': '664566'}, {'name': 'Wangyang Meng, MD', 'role': 'CONTACT', 'email': 'mengwymed@163.com', 'phone': '00861592767592'}], 'overallOfficials': [{'name': 'Hecheng Li, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'De-identified baseline characteristics, outcomes, and adverse events.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}