Ignite Creation Date:
2025-12-24 @ 3:19 PM
Ignite Modification Date:
2025-12-24 @ 3:19 PM
Study NCT ID:
NCT06892392
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-24
First Post:
2025-03-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Application of Indocyanine Green Tracer in D2 Lymphadenectomy of Locally Advanced Gastric Cancer
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2032-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-18', 'studyFirstSubmitDate': '2025-03-10', 'studyFirstSubmitQcDate': '2025-03-18', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total nodes resected', 'timeFrame': '18 months', 'description': 'Mean of the total nodes resected in the D2 lymphadenectomy'}, {'measure': 'Nodal ratio', 'timeFrame': '18 months', 'description': 'number of positive nodes divided by number of total nodes'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '2 and 5 years', 'description': 'Overall survival at 2 and 5 years'}, {'measure': 'Disease-free survival', 'timeFrame': '2 and 5 years', 'description': 'Disease-free survival at 2 and 5 years'}, {'measure': 'Number of metastatic nodes', 'timeFrame': '18 months', 'description': 'Number of metastatic nodes'}, {'measure': 'Comprehensive Complication Index', 'timeFrame': '30 days after surgery', 'description': 'Comprehensive Complication Index (CCI)'}, {'measure': 'Intraoperative bleeding volume', 'timeFrame': '18 months', 'description': 'Intraoperative bleeding volume (ml)'}, {'measure': 'Surgical time', 'timeFrame': '18 months', 'description': 'Surgical time (minutes)'}, {'measure': 'Days of hospitalization', 'timeFrame': '18 months', 'description': 'Days of hospitalization'}, {'measure': 'Correlation of positive lymph nodes in anatomical pathology and with ICG uptake', 'timeFrame': '18 months', 'description': 'Correlation of positive lymph nodes in anatomical pathology and with ICG uptake'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multicenter randomized 1:1 clinical trial', 'indocyanine green', 'Laparoscopic gastrectomy with D2 lymphadenectomy'], 'conditions': ['GASTRIC CANCER', 'Indocyanine Green (ICG)', 'Lymph Node Excision', 'Lymphadenectomy', 'Laparoscopic Gastrectomy']}, 'descriptionModule': {'briefSummary': 'Gastric cancer is a frequent neoplasm in the world, presenting more than one million new cases and around 768,000 deaths in the data registered in 2020. Among the therapeutic options for gastric cancer, surgery is an essential pillar for its treatment. Gastric cancer surgery consists of gastric resection with negative margins and radical lymphadenectomy in patients without distant metastases. It has been demonstrated over the years that radical lymphadenectomy in gastric cancer allows for adequate staging and improved long-term survival.\n\nIn order to perform a correct staging using the TNM system, it is necessary to resect at least 15 lymph nodes in the radical lymphadenectomy. For radical lymphadenectomy staging, the Japanese Gastric Cancer Association defined and subdivided nodal stations. Three types of lymphadenectomy are described according to oncologic gastric resections (D1, D1+ and D2), with D2 lymphadenectomy being the standard of treatment for locally advanced gastric tumors. Performing an insufficient or inadequate lymphadenectomy has been shown to negatively impact survival after gastrectomy in such a cohort.\n\nThe development of technology based on fluorescence guided by indocyanine green could improve the technique and results of D2 lymphadenectomy in patients with gastric cancer. There is evidence that the application of ICG in D2 lymphadenectomy increases the number of resected nodes, however, studies of higher scientific quality (randomized clinical trials) are needed. Furthermore, most studies in this field have focused on Eastern countries (Japan, Korea and China), where the percentage of early tumors and chemotherapy treatment is different from Western centers.\n\nTherefore, we propose a multicenter randomized clinical trial aimed at evaluating whether the application of ICG-guided fluorescence-based technology in D2 lymphadenectomy of locally advanced gastric cancer increases the number of resected nodes, improves the oncologic quality of the lymphadenectomy, and thus may increase overall survival and disease-free survival at 2 and 5 years postoperatively.', 'detailedDescription': 'Objective:\n\n\\- Mean total number of nodes/ nodal ratio (number of positive nodes divided by the number of total nodes).\n\nSecondary objective:\n\n* Overall Survival and disease- free survival at 2 and 5 years.\n* Number of metastatic nodes\n* Complications measured with the Comprehensive Complication Index (CCI)\n* Intraoperative bleeding volume\n* Surgical time (minutes)\n* Days of hospitalization (days) Randomized clinical trial 1:1. The patient will be included once the perioperative chemotherapy treatment is completed. The investigator at each center will explain the study, and if the patient consents to participate, he/she will sign the informed consent form (IC). After which, the investigator of each center will contact the principal investigator of the University Hospital of Navarra (HUN), who will perform the randomization and communicate the result by email to the participating center.\n\nRequirements for participating centers:\n\n* Esophagogastric Surgery Unit with a volume of 20 patients with gastric neoplasia operated on in one year.\n* Use the 4k Rubina Tower of the Karl Storz brand.\n\nInclusion criteria:\n\n* \\< 85 years\n* T1/T4a, N+, M0 in the preoperative study.\n* PS 0-1\n* ASA I-III\n* Laparoscopic surgery\n\nExclusion criteria:\n\n* Previous gastric abdominal surgery\n* DSE\n* Cognitive impairment\n* Allergic to iodine\n* Synchronous neoplasm\n* Stroke in the last 6 months\n* Angina or AMI in the last 6 months\n* Plastic lymphitis\n* Open surgery\n\nICG administration: For ICG administration, a gastroscopy must be performed by the Digestive Service of each center, with sedation 24 hours before surgery. For this, the lesion is located by gastroscopy, after which it is injected in 4 quadrants in the submucosa, with a total volume of 2 ml.\n\nTo prepare the ICG, 0.5 ml (containing 0.625 mg of ICG) is dissolved in 1.25 mg/dl of sterile water.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* T2-T4a, N+, M0 on preoperative study\n* PS 0-1\n* ASA I-III\n* Laparoscopic surgery\n\nExclusion Criteria:\n\n* \\- Previous gastric abdominal surgery\n* DSE\n* Cognitive impairment\n* Allergic to iodine\n* Synchronous neoplasm\n* Stroke in the last 6 months\n* Angina or AMI in the last 6 months\n* Plastic lymphitis\n* Open surgery'}, 'identificationModule': {'nctId': 'NCT06892392', 'acronym': 'Gastri-ICG', 'briefTitle': 'Application of Indocyanine Green Tracer in D2 Lymphadenectomy of Locally Advanced Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hospital of Navarra'}, 'officialTitle': 'Aplicación Del ICG En La Linfadenectomía D2 Laparoscópica Del Cáncer Gástrico Localmente Avanzado: Ensayo Clínico Aleatorizado Multicéntrico.', 'orgStudyIdInfo': {'id': 'Hospital Universitario de Nava'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group, Subtotal/Total gastrectomy with D2 lymphadenectomy LPS ( standar of care)', 'description': '* Tumor localization and assessment of resectability\n* Omentectomy\n* Ligation and dissection of the right gastroepiploic vessels at their origin.\n* Dissection of lymph node group 6\n* Opening of the pars flaccida of the lesser omentum.\n* Dissection and ligation of the pyloric artery at its origin\n* Dissection of ganglionic group 5\n* Dissection and section of the first portion of the duodenum.\n* Lymphadenectomy D2: 7, 8, 9, 9, 11 p, 12a\n* Ligation and section of the coronary artery at origin\n* Group 1 lymphadenectomy\n* Gastric section with negative margin\n* Removal of the specimen\n* Reconstruction according to the usual technique\n\nEx vivo analysis of the specimen in the surgical block. A dissection of the D2 lymphadenectomy lymph node groups will be performed including the following groups according to the Japanese Gastric Cancer Association Classification:\n\n\\- Group 7, 8, 9, 11 p, 12 a. Each lymph node group will be sent in a separate labeled sample bottle to the pathology department.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group: ICG administration', 'description': 'ICG administration: For ICG administration, a gastroscopy must be performed by the Digestive Service of each center, with sedation 24 h before surgery. For this, the lesion is located by gastroscopy, after which it is injected in 4 quadrants in the submucosa, with a total volume of 2 ml.\n\nTo prepare the ICG, 0.5 ml (containing 0.625 mg of ICG) is dissolved in 1.25 mg/dl of sterile water\n\nStandard Total or Subtotal gastrectomy and D2 lymphadenectomy will be performed. After removal of the specimen, we will use ICG mode and evaluate if there are foci of uptake in the territory of the D2 lymphadenectomy.\n\n\\- If there are foci of uptake, dissect and resect them. Identified in a separate anatomic pathology jar and labeled with the name of the corresponding anatomic region with ICG', 'interventionNames': ['Procedure: ICG administration']}], 'interventions': [{'name': 'ICG administration', 'type': 'PROCEDURE', 'otherNames': ['ICG'], 'description': 'For the administration of ICG, it is necessary to perform a gastroscopy by the Digestive Service of each center, with sedation 24 h before surgery. For this, the lesion is located by gastroscopy, after which it is injected in 4 quadrants in the submucosa, with a total volume of 2 ml.\n\nTo prepare the ICG, 0.5 ml (containing 0.625 mg of ICG) is dissolved in 1.25 mg/dl of sterile water', 'armGroupLabels': ['Intervention group: ICG administration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310013', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'contacts': [{'name': 'Eguaras Inés, MD, PhD', 'role': 'CONTACT', 'email': 'ineseguaras@hotmail.com', 'phone': '0034666909487'}], 'facility': 'Hospital Universitario de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}], 'centralContacts': [{'name': 'Inés Eguaras, MD, PhD', 'role': 'CONTACT', 'email': 'ineseguaras@hotmail.com', 'phone': '+34666909487'}], 'overallOfficials': [{'name': 'Maria Concepcion Yarnoz, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital of Navarra'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital of Navarra', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ines Eguaras', 'investigatorAffiliation': 'Hospital of Navarra'}}}}