Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT06945718
Status:
RECRUITING
Last Update Posted:
2025-05-08
First Post:
2025-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Extended Lymphadenectomy Beyond D2 for Locally Advanced Gastric Cancer (FUGES-30)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 760}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2030-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2025-03-21', 'studyFirstSubmitQcDate': '2025-04-20', 'lastUpdatePostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-year disease free survival rate', 'timeFrame': '3 years', 'description': 'Disease-free survival is calculated from the day of surgery to the day of recurrence or death'}], 'secondaryOutcomes': [{'measure': 'Total number of retrieved lymph nodes', 'timeFrame': '30 days', 'description': 'Total number of retrieved lymph nodes'}, {'measure': 'Noncompliance rate of lymph node dissection', 'timeFrame': '30 days', 'description': 'The LN dissection rate was determined by the number of patients in whom a LN station was harvested divided by the total number of patients who required retrieval at the corresponding LN station. Within the scope of D2 dissection, LN noncompliance was defined as the absence of LNs that should have been resected from \\> 1 LN station.'}, {'measure': 'Relationship between fluorescent lymph nodes in group A and total number of lymph nodes in group A', 'timeFrame': '30 days', 'description': 'Relationship between the number of fluorescent lymph nodes in group A and total number of lymph nodes in group A'}, {'measure': 'Relationship between fluorescent lymph nodes in Group A and positive lymph nodes in Group A (positive rate)', 'timeFrame': '30 days', 'description': 'The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in Group A (True positive rate).'}, {'measure': 'Relationship between fluorescent lymph nodes in Group A and negative lymph nodes in Group A (false positive rate)', 'timeFrame': '30 days', 'description': 'The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in Group A (false positive rate).'}, {'measure': 'Relationship between non-fluorescent lymph nodes in Group A and negative lymph nodes in group A (negative rate)', 'timeFrame': '30 days', 'description': 'The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in group A (True negative rate).'}, {'measure': 'Relationship between nonfluorescent lymph nodes in Group A and positive lymph nodes in Group A (false negative rate)', 'timeFrame': '30 days', 'description': 'The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in Group A (false negative rate).'}, {'measure': 'Relationship between fluorescent lymph nodes in group B and total number of lymph nodes in group B', 'timeFrame': '30 days', 'description': 'Relationship between the number of fluorescent lymph nodes in group B and total number of lymph nodes in group B'}, {'measure': 'Relationship between fluorescent lymph nodes in Group B and positive lymph nodes in Group B (positive rate)', 'timeFrame': '30 days', 'description': 'The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in Group B (True positive rate).'}, {'measure': 'Relationship between fluorescent lymph nodes in Group B and negative lymph nodes in Group B (false positive rate)', 'timeFrame': '30 days', 'description': 'The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in Group A (false positive rate).'}, {'measure': 'Relationship between non-fluorescent lymph nodes in Group B and negative lymph nodes in group B (negative rate)', 'timeFrame': '30 days', 'description': 'The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in group B (True negative rate).'}, {'measure': 'Relationship between nonfluorescent lymph nodes in Group B and positive lymph nodes in Group B (false negative rate)', 'timeFrame': '30 days', 'description': 'The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in Group B (false negative rate).'}, {'measure': 'Number of metastatic lymph nodes', 'timeFrame': '30 days', 'description': 'Number of metastatic lymph nodes'}, {'measure': 'Metastasis rate of lymph nodes', 'timeFrame': '30 days', 'description': 'Metastasis rate of lymph nodes'}, {'measure': 'Postoperative complications', 'timeFrame': '30 days', 'description': 'Postoperative complications were evaluated within 30 days following surgery. These postoperative complications include gastrointestinal-related complications, incision-related complications, respiratory complications, cardiovascular and cerebrovascular complications, urinary system complications, infection complications, embolism complications, and other complications. The grading of postoperative complications adopts the Clavien-Dindo classification.'}, {'measure': 'Mortality rates', 'timeFrame': '30 days', 'description': 'Patient died during hospitalization.'}, {'measure': '3-year overall survival rate', 'timeFrame': '3 years', 'description': '3-year overall survival rate'}, {'measure': '3-year recurrence pattern', 'timeFrame': '3 years', 'description': '3-year recurrence pattern'}, {'measure': 'Postoperative recovery course', 'timeFrame': '30 days', 'description': 'Time to first flatus after surgery, time to first ambulation after surgery, time to first liquid diet after surgery, time to first semi-liquid diet after surgery, length of hospital stay after surgery.'}, {'measure': 'The incidence of intraoperative complications', 'timeFrame': '30 days', 'description': 'Intraoperative complications were defined as bleeding due to named vessel injury, injury to visceral organs, mechanical factor-related problems, cardiopulmonary dysfunction due to hypercapnia, and other complications'}, {'measure': 'Inflammatory and immune response', 'timeFrame': '7 days', 'description': 'the values of hemoglobin, prealbumin, albumin, C-reactive protein, and white blood cell count from peripheral blood before the operation and on postoperative day 1, 3, 5 are recorded.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastric Cancer', 'Laparoscopic Gastrectomy', 'Indocyanine Green Tracer'], 'conditions': ['Gastric Cancer', 'Surgery']}, 'descriptionModule': {'briefSummary': 'Taking patients with locally advanced gastric adenocarcinoma (cT2-4a, N-/+, M0) as the research subjects, to evaluate whether the clinical efficacy of laparoscopic beyond D2 regional lymph node dissection for gastric cancer with indocyanine green tracer is better or not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Age from 18 to 75 years Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 8th Edition', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge from 18 to 75 years Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 8th Edition No distant metastasis, no direct invasion of pancreas, spleen or other adjacent organs in the preoperative examinations Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale ASA (American Society of Anesthesiology) class I to III Written informed consent\n\nExclusion Criteria:\n\nWomen during pregnancy or breast-feeding Severe mental disorder History of previous upper abdominal surgery (except for laparoscopic cholecystectomy) History of previous gastric surgery (including ESD/EMR for gastric cancer) Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging including enlarged or bulky lymph nodes in D3 region.\n\nOther malignant disease within the past 5 years History of unstable angina or myocardial infarction within past six months History of cerebrovascular accident within past six months History of continuous systematic administration of corticosteroids within one month Requirement for simultaneous surgery for other disease Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer FEV1 (forced expiratory volume in one second)\\<50% of predicted values Diffuse invasive gastric cancer Tumors preoperatively confirmed to involve the squamocolumnar junction or duodenum History of an iodine allergy Patients who declined laparoscopic surgery'}, 'identificationModule': {'nctId': 'NCT06945718', 'briefTitle': 'Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Extended Lymphadenectomy Beyond D2 for Locally Advanced Gastric Cancer (FUGES-30)', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Medical University'}, 'officialTitle': 'Prospective Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With D2 Extra-regional Lymph Node Dissection for Locally Advanced Gastric Cancer (FUGES-30)', 'orgStudyIdInfo': {'id': 'FUGES-30'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'laparoscopic gastrectomy with beyond D2 regional fluorescent lymph node dissection with ICG group', 'description': 'ICG with D2+ group', 'interventionNames': ['Procedure: beyond D2 regional lymph node dissection']}, {'label': 'laparoscopic gastrectomy with D2 regional lymph node dissection with ICG group', 'description': 'ICG with D2 group', 'interventionNames': ['Procedure: beyond D2 regional lymph node dissection']}], 'interventions': [{'name': 'beyond D2 regional lymph node dissection', 'type': 'PROCEDURE', 'description': 'dissect the lymph nodes outside the extent of D2 LN region.', 'armGroupLabels': ['laparoscopic gastrectomy with D2 regional lymph node dissection with ICG group', 'laparoscopic gastrectomy with beyond D2 regional fluorescent lymph node dissection with ICG group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350001', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Changming Huang, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'hcmlr2002@163.com', 'phone': '+86-133-6591-0253'}, {'name': 'Changming Huang, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fujian Medical University Union Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'centralContacts': [{'name': 'Mi Lin, phD', 'role': 'CONTACT', 'email': 'silihuala@qq.com', 'phone': '13459152658'}, {'name': 'Hua-Long Zheng, phD', 'role': 'CONTACT', 'email': '291167038@qq.com', 'phone': '18359190587'}], 'overallOfficials': [{'name': 'Chang-Ming Huang, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fujian Medical University Union Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief doctor, phD, FACS', 'investigatorFullName': 'Chang-Ming Huang, Prof.', 'investigatorAffiliation': 'Fujian Medical University'}}}}