Ignite Creation Date:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
Study NCT ID:
NCT04615806
Status:
UNKNOWN
Last Update Posted:
2022-01-25
First Post:
2020-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in 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': 'D007208', 'term': 'Indocyanine Green'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-23', 'studyFirstSubmitDate': '2020-10-27', 'studyFirstSubmitQcDate': '2020-11-03', 'lastUpdatePostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy rate of lymph node dissection', 'timeFrame': '1 week after operation', 'description': 'Accuracy rate of lymph node dissection of each arm（according to postoperative pathology）'}, {'measure': 'False positive rate of lymph node dissection', 'timeFrame': '1 week after operation', 'description': 'False positive rate of lymph node dissectionof each arm（according to postoperative pathology）'}, {'measure': 'False negative rate of lymph node dissection', 'timeFrame': '1 week after operation', 'description': 'False negative rate of lymph node dissection of each arm（according to postoperative pathology）'}, {'measure': 'Sensitivity and specificity of lymph node dissection', 'timeFrame': '1 week after operation', 'description': 'Sensitivity and specificity of lymph node dissection of each arm（according to postoperative pathology）'}], 'secondaryOutcomes': [{'measure': 'The mapping of sentinel lymph nodes in esophageal cancer', 'timeFrame': '1 week after operation', 'description': 'The mapping of sentinel lymph nodes in esophageal cancer'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Esophageal Cancer', 'Indocyanine Green', 'the lymph node markers'], 'conditions': ['Esophageal Cancer', 'Indocyanine Green']}, 'referencesModule': {'references': [{'pmid': '38012899', 'type': 'DERIVED', 'citation': 'Du J, Zeng T, Zhang S, Chen M, Huang G, Xu C, Xu G, Ni C, Hong R, Zheng W, Chen C, Zheng B. Comparison of indocyanine green-near-infrared fluorescence guided and traditional mediastinal lymphadenectomy during radical esophagectomy: A randomized controlled trial. Surgery. 2024 Feb;175(2):347-352. doi: 10.1016/j.surg.2023.10.007. Epub 2023 Nov 26.'}, {'pmid': '35770339', 'type': 'DERIVED', 'citation': 'Du J, Xu G, Yang Z, Zheng B, Chen C. Pericancerous lymph node imaging with indocyanine green-guided near-infrared fluorescence in radical esophagectomy: Protocol for a single-center, prospective, randomized controlled clinical trial. Thorac Cancer. 2022 Aug;13(15):2283-2287. doi: 10.1111/1759-7714.14548. Epub 2022 Jun 29.'}]}, 'descriptionModule': {'briefSummary': 'Indocyanine green (ICG) has been recently introduced in clinical practice as a fuorescent tracer. Lymphadenectomy is particularly challenging in esophageal cancer surgery, owing to the complex anatomical drainage.Therefore, the purpose of this study was to explore whether the NIR-ICG imaging system could accurately assess the lymph node markers during radical resection of esophageal cancer.', 'detailedDescription': 'This study will be accepted in esophageal cancer patients with Radical Esophag-ectomy as the research object.We will divide them into two groups: experimental group for injection of indocyanine green group and control group for injectable in-docyanine green group.We will compare with the accuracy,false positive rate and false negative rate,sensitivity, specificity and related indicators of intraoperative lymph node cleaning,in order to explore the common position of esophageal cancer sentinel lymph node,guidance of esophageal cancer lymph node cleaning thoroughly.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age and gender: 18-75 years old, male and female unlimited;\n2. Preoperative biopsy was pathologically diagnosed as esophageal squamous cell carcinoma;\n3. Preoperative combination with neoadjuvant chemoradiotherapy;\n4. Surgical resection of esophageal carcinoma under endoscopic selection and intraoperative anastomosis;\n5. Heart, lung, liver and kidney functions can tolerate operation;\n6. Patients and their family members can understand and are willing to participate in this clinical study and sign the informed consent.\n\nExclusion Criteria:\n\n1. Allergic to ICG or iodine;\n2. Patients with a history of chest surgery or thoracic lymph node dissection;\n3. Patients needing emergency surgery;\n4. Patients whose tumors involve neighboring organs and need to be removed by combining organs;\n5. Patients with tumor recurrence or distant metastasis;\n6. Patients who had participated in or were participating in other clinical trials within the previous 4 weeks were included;\n7. A history of serious mental illness;\n8. Pregnant or lactating women;\n9. Patients with other conditions considered by the researcher should not participate in the study.'}, 'identificationModule': {'nctId': 'NCT04615806', 'briefTitle': 'The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Esophagectomy', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Medical University Union Hospital'}, 'officialTitle': 'The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Video-assisted Thoracoscope Radical Esophagectomy', 'orgStudyIdInfo': {'id': 'ICG-NIR UNION'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NIR-ICG', 'description': 'After positioning,Indocyanine green（ICG） dye (Yichuang Pharmaceutical, Liaoning, China) stored at a dose of 25 mg in a small bottle was diluted with 5 ml sterile water. Then, 2 ml of this solution was added to 8 ml sterile water in a dis-posable dressing bowl, resulting in a final concentration of 1.25 mg/ml.', 'interventionNames': ['Drug: Indocyanine green solution']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'This group of patients received only conventional radical resection of esophageal cancer without Indocyanine green injection.'}], 'interventions': [{'name': 'Indocyanine green solution', 'type': 'DRUG', 'otherNames': ['Indocyanine Green for Injection'], 'description': 'ICG solution was endoscopically injected into the esophageal submucosa at the four quadrants around the tumor.', 'armGroupLabels': ['NIR-ICG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350001', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bin Zheng, MD', 'role': 'CONTACT', 'email': 'Dujt1220@qq.com', 'phone': '13023806690'}], 'facility': 'Fujian Medical University Union Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'centralContacts': [{'name': 'Bin Zheng, MD', 'role': 'CONTACT', 'email': 'Dujt1220@qq.com', 'phone': '13023806690'}], 'overallOfficials': [{'name': 'Chun Chen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fujian Medical University Union Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Medical University Union Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}