Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-30 @ 2:19 PM
Study NCT ID:
NCT06593132
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Port Endoscopic Breast Conserving Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-10', 'studyFirstSubmitDate': '2024-08-27', 'studyFirstSubmitQcDate': '2024-09-10', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Six months after operation SURVIVAL EFFECTS', 'timeFrame': 'From enrollment to the end of 6 months after surgery', 'description': 'To compare the overall survival (OS) within 6 months after single-port endoscopic breast-conserving surgery and open breast-conserving surgery.'}], 'secondaryOutcomes': [{'measure': 'Intraoperative blood loss', 'timeFrame': 'From the beginning to the end of the operation', 'description': 'To compare the total blood loss between single-port endoscopic breast-conserving surgery and open breast-conserving surgery.'}, {'measure': 'Postoperative drainage volume in the first three days after breast conserving surgery', 'timeFrame': '3 days after surgery', 'description': 'The total drainage volume in the first three days after breast conserving surgery was compared between single-port endoscopic breast conserving surgery and open breast conserving surgery.'}, {'measure': 'Length of surgical incision', 'timeFrame': '1 week after surgery', 'description': 'The total incision length was compared between single-port endoscopic breast-conserving surgery and open breast-conserving surgery.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast conserving surgery', 'single port endoscopic', 'early breast cancer'], 'conditions': ['Breast Conserving Surgery', 'Endoscopic Surgery']}, 'descriptionModule': {'briefSummary': 'The center plans to carry out a prospective clinical study of single hole total endoscopic breast conserving surgery for early breast cancer compared with open breast conserving surgery, to provide high-level evidence-based medical evidence for the development of endoscopic breast conserving surgery for early breast cancer.', 'detailedDescription': 'Data show that breast cancer has surpassed lung cancer asthemost prevalent malignant tumor in the world, and traditional open surgery is highly invasive and has poor cosmetic results. This study investigates the results of endoscopic breast- conserving surgery(E-BCS) versus conventional breast-conserving surgery(C-BCS) in the treatment of patients with early-stage breast cancer and to compare the advantages and disadvantages of the two surgical procedures, so as to provide the best evidence for the rational choice of the procedure by both doctors and patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Female patients aged 20-70 years who are eligible for breast-conserving surgery and are willing to undergo breast-conserving surgery.', 'genderDescription': 'All participants are women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Breast cancer confirmed by pathology；\n2. Tumor \\<5 cm, TNM stage 0-II；\n3. Single Port Endoscopic or traditional open surgery; (4)20 to 70 years old female patients.\n\nExclusion Criteria:\n\n1. Bilateral breast cancer;\n2. Reconstruction after breast conserving surgery ;\n3. Basic information is not complete；\n4. Breast conserving surgery was converted to modified radical resection or subcutaneous adenoidectomy.'}, 'identificationModule': {'nctId': 'NCT06593132', 'briefTitle': 'Single Port Endoscopic Breast Conserving Surgery', 'organization': {'class': 'OTHER', 'fullName': "First Affiliated Hospital Xi'an Jiaotong University"}, 'officialTitle': 'Prospective Clinical Study of Single Port Endoscopic Breast Conserving Surgery or Open Breast Conserving Surgery for Early Breast Cancer', 'orgStudyIdInfo': {'id': 'SPEBCS-2023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'single port endoscopic breast conserving surgery', 'description': 'Endoscopic breast conserving surgery, which uses breast endoscope for breast conserving surgery, can not only preserve the breast completely, but also meet the appearance needs of patients with breast preservation, and has more advantages than traditional surgery.', 'interventionNames': ['Procedure: endoscopic breast conserving surgery']}, {'label': 'open breast conserving surgery', 'description': 'On the surface of the breast tumor centered, is apart from the 2 cm do arc, radial incision tumor, tags in the cut edge around the joints and removing tissue inspection, to ensure the cut edge negative.', 'interventionNames': ['Procedure: endoscopic breast conserving surgery']}], 'interventions': [{'name': 'endoscopic breast conserving surgery', 'type': 'PROCEDURE', 'description': 'Breast endoscopy technology completes complex surgical operations through small incisions, achieving aesthetically pleasing results while ensuring tumor safety.', 'armGroupLabels': ['open breast conserving surgery', 'single port endoscopic breast conserving surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710061', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu Ren, MD,PhD', 'role': 'CONTACT', 'email': 'renyyyyy@126.com', 'phone': '13700222161'}], 'facility': "the First Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Zhaoli Nan, bacheior', 'role': 'CONTACT', 'email': '369075227@qq.com', 'phone': '15114822852'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ren,Yu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'chief physician', 'investigatorFullName': 'Ren,Yu', 'investigatorAffiliation': "First Affiliated Hospital Xi'an Jiaotong University"}}}}