Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-30 @ 11:04 AM
Study NCT ID:
NCT05433467
Status:
RECRUITING
Last Update Posted:
2025-08-13
First Post:
2022-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CT-guided Localization for Micro Hepatocellular Carcinoma Before Surgical Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2022-06-21', 'studyFirstSubmitQcDate': '2022-06-21', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The position of the needle', 'timeFrame': 'During operation', 'description': 'The distance (mm) of the needle to the edge of hepatocellular carcinoma'}], 'secondaryOutcomes': [{'measure': 'Operation time', 'timeFrame': 'During operation', 'description': 'The length of operation time (min)'}, {'measure': 'Intraoperative bleeding', 'timeFrame': 'During operation', 'description': 'The volume of intraoperative bleeding (ml)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cirrhosis', 'hepatocellular carcinoma', 'localization needle'], 'conditions': ['Cirrhosis, Liver', 'Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'In this project, the preoperative anatomical location of micro hepatocellular carcinoma under the guidance of CT can provide guidance for accurate surgical resection. It may also shorten the operation time and reduce intraoperative bleeding.', 'detailedDescription': 'General and basic information of the patients included in the study was collected. After preoperative preparation was completed, on the day of surgery, disposable pulmonary nodular localization needle (Ningbo Sonjiecang Biological Technology Co., LTD., Model: SS510-10) was used for the localization of micro hepatocellular carcinoma that could be found by preoperative CT enhancement or MRI. After the micro hepatocellular carcinoma was located under the guidance of CT, and then the patient was sent to the operating room. During the operation, the lesion was removed according to the tail line of the positioning needle and the position of the positioning needle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Be at least 18 years old and give informed consent to participate in the study\n2. A preoperative (clinical, radiological, or histological) diagnosis of cirrhosis of the liver due to any cause.\n3. micro hepatocellular carcinoma (diameter less than 1cm).\n4. Preoperative CT plain scan could not find the lesion, and preoperative B-ultrasound could not find the lesion.\n5. Preoperative CT enhancement or MRI can detect the lesion.\n\nExclusion Criteria:\n\n1. Child-Pugh grade C\n2. Uncontrolled Hypertension\n3. Severe lung dysfunction\n4. Severe cardiac dysfunction'}, 'identificationModule': {'nctId': 'NCT05433467', 'acronym': 'CTMH', 'briefTitle': 'CT-guided Localization for Micro Hepatocellular Carcinoma Before Surgical Resection', 'organization': {'class': 'OTHER', 'fullName': "Northern Jiangsu People's Hospital"}, 'officialTitle': 'The Feasibility of CT-guided Localization for Micro Hepatocellular Carcinoma Before Surgical Resection', 'orgStudyIdInfo': {'id': 'YZUC-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CT-guided localization for micro hepatocellular carcinoma before surgical resection', 'description': 'fter preoperative preparation was completed, on the day of surgery, disposable pulmonary nodular localization needle (Ningbo Sonjiecang Biological Technology Co., LTD., Model: SS510-10) was used for the localization of micro hepatocellular carcinoma that could be found by preoperative CT enhancement or MRI. After the micro hepatocellular carcinoma was located under the guidance of CT, and then the patient was sent to the operating room. During the operation, the lesion was removed according to the tail line of the positioning needle and the position of the positioning needle.', 'interventionNames': ['Procedure: CT-guided localization for micro hepatocellular carcinoma before surgical resection']}], 'interventions': [{'name': 'CT-guided localization for micro hepatocellular carcinoma before surgical resection', 'type': 'PROCEDURE', 'description': 'After preoperative preparation was completed, on the day of surgery, disposable pulmonary nodular localization needle (Ningbo Sonjiecang Biological Technology Co., LTD., Model: SS510-10) was used for the localization of micro hepatocellular carcinoma that could be found by preoperative CT enhancement or MRI. After the micro hepatocellular carcinoma was located under the guidance of CT, and then the patient was sent to the operating room. During the operation, the lesion was removed according to the tail line of the positioning needle and the position of the positioning needle.', 'armGroupLabels': ['CT-guided localization for micro hepatocellular carcinoma before surgical resection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '225001', 'city': 'Yangzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guo-Qing Jiang, MD', 'role': 'CONTACT', 'email': 'jgqing2003@hotmail.com', 'phone': '86-514-87373372'}, {'name': 'Dou-Sheng Bai, MD', 'role': 'CONTACT', 'email': 'bdsno1@hotmail.com', 'phone': '86-514-87373372'}, {'name': 'Guo-Qing Jiang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tian-Ming Gao, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Clinical Medical College, Yangzhou University', 'geoPoint': {'lat': 32.39722, 'lon': 119.43583}}], 'centralContacts': [{'name': 'Guo-Qing Jiang, MD', 'role': 'CONTACT', 'email': 'jgqing2003@hotmail.com', 'phone': '+8651487373382'}, {'name': 'Dou-Sheng Bai, MD', 'role': 'CONTACT', 'email': 'jgqing2003@hotmail.com', 'phone': '+8651487373382'}], 'overallOfficials': [{'name': 'Guo-Qing Jiang, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Clinical Medical College, Yangzhou University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Northern Jiangsu People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Guo-Qing Jiang', 'investigatorAffiliation': "Northern Jiangsu People's Hospital"}}}}