Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT07295002
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sentinel Node Resection With or Without LECS After Noncurative ESD for EGC
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010535', 'term': 'Laparoscopy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-09-02', 'size': 138553, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-11-24T08:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-11-15', 'studyFirstSubmitQcDate': '2025-12-15', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severe complications defined as Clavien-Dindo >/= III', 'timeFrame': 'Periprocedural', 'description': 'Safety of the procedure, defined as Clavien-Dindo complication grade \\>/= III'}], 'secondaryOutcomes': [{'measure': 'Any complications', 'timeFrame': 'Periprocedural', 'description': 'Any complication during the procedure (Clavien-Dindo II-IV)'}, {'measure': 'Postoperative bleeding', 'timeFrame': 'Periprocedural', 'description': 'Postoperative bleeding requiring blood transfusion'}, {'measure': 'Leakage', 'timeFrame': 'Periprocedural', 'description': 'Leakage/postoperative abscess requiring drainage'}, {'measure': 'Operation time', 'timeFrame': 'Periprocedural', 'description': 'Time of the surgical procedure'}, {'measure': 'Pathological tumor (T)-stage', 'timeFrame': 'Up to 2 months post procedure', 'description': 'Depth of tumor invasion into the gastric wall (for LECS cases)'}, {'measure': 'Tumor-free resection margins', 'timeFrame': 'Up to 2 months post procedure', 'description': 'The rate of horizontal and vertical margins free of tumor cells (for LECS cases).'}, {'measure': 'Number of lymph nodes', 'timeFrame': 'Periprocedural', 'description': 'Number of lymph nodes harvested during the procedure'}, {'measure': 'Number of positive lymph nodes', 'timeFrame': 'Up to 2 months post procedure', 'description': 'Number of lymph nodes positive for cancer'}, {'measure': 'Hospital-stay', 'timeFrame': 'From the day of the procedure until patient is discharged from the hospital, assessed up to 12 weeks post procedure', 'description': 'Number of days from the procedure until discharge'}, {'measure': 'Health-related quality of life (HQL) score QLQ-30', 'timeFrame': 'Preoperatively, after 30 days and 1 year', 'description': 'Pre and postoperative HQL, tested with the validated score QLQ-C30 (The EORTC QLG Core Questionnaire for cancer patients)'}, {'measure': 'Health-related quality of life (HQL) score OG25', 'timeFrame': 'Preoperatively, after 30 days and 1 year', 'description': 'Pre and postoperative HQL, tested with the validated score OG25 (The EORTC QLG Module Questionnaire specifically for esophago-gastric patients)'}, {'measure': '30-day mortality', 'timeFrame': 'From procedure to maximum 30 days postoperatively', 'description': '30-day mortality'}, {'measure': 'In-hospital mortality', 'timeFrame': 'From the day of the procedure until patient is discharged from the hospital, assessed up to 12 weeks post procedure', 'description': 'In-hospital mortality'}, {'measure': '1-year disease-free survival', 'timeFrame': 'Until 1 year after the procedure', 'description': '1-year disease-free survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sentinel node-resection', 'minimal invasive surgery'], 'conditions': ['Early Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '35836598', 'type': 'BACKGROUND', 'citation': "Belia F, Biondi A, Agnes A, Santocchi P, Laurino A, Lorenzon L, Pezzuto R, Tirelli F, Ferri L, D'Ugo D, Persiani R. The Use of Indocyanine Green (ICG) and Near-Infrared (NIR) Fluorescence-Guided Imaging in Gastric Cancer Surgery: A Narrative Review. Front Surg. 2022 Jun 28;9:880773. doi: 10.3389/fsurg.2022.880773. eCollection 2022."}, {'pmid': '37666656', 'type': 'BACKGROUND', 'citation': 'Morais R, Libanio D, Dinis Ribeiro M, Ferreira A, Barreiro P, Bourke MJ, Gupta S, Amaro P, Kuttner Magalhaes R, Cecinato P, Boal Carvalho P, Pinho R, Rodriguez de Santiago E, Sferrazza S, Lemmers A, Figueiredo M, Pioche M, Gallego F, Albeniz E, Ramos Zabala F, Uchima H, Berr F, Wagner A, Marques M, Pimentel-Nunes P, Goncalves M, Mascarenhas A, Soares EG, Xavier S, Faria-Ramos I, Sousa-Pinto B, Gullo I, Carneiro F, Macedo G, Santos-Antunes J. Predicting residual neoplasia after a non-curative gastric ESD: validation and modification of the eCura system in the Western setting: the W-eCura score. Gut. 2023 Dec 7;73(1):105-117. doi: 10.1136/gutjnl-2023-330804.'}, {'pmid': '32818901', 'type': 'BACKGROUND', 'citation': 'van den Boorn HG, Stroes CI, Zwinderman AH, Eshuis WJ, Hulshof MCCM, van Etten-Jamaludin FS, Sprangers MAG, van Laarhoven HWM. Health-related quality of life in curatively-treated patients with esophageal or gastric cancer: A systematic review and meta-analysis. Crit Rev Oncol Hematol. 2020 Oct;154:103069. doi: 10.1016/j.critrevonc.2020.103069. Epub 2020 Aug 5.'}, {'pmid': '36808262', 'type': 'BACKGROUND', 'citation': 'Tsekrekos A, Vossen LE, Lundell L, Jeremiasen M, Johnsson E, Hedberg J, Edholm D, Klevebro F, Nilsson M, Rouvelas I. Improved survival after laparoscopic compared to open gastrectomy for advanced gastric cancer: a Swedish population-based cohort study. Gastric Cancer. 2023 May;26(3):467-477. doi: 10.1007/s10120-023-01371-8. Epub 2023 Feb 19.'}, {'pmid': '29761671', 'type': 'BACKGROUND', 'citation': 'Nevo Y, Goldes Y, Barda L, Nadler R, Gutman M, Nevler A. Risk Factors for Complications of Total/Subtotal Gastrectomy for Gastric Cancer: Prospectively Collected, Based on the Clavien-Dindo Classification System. Isr Med Assoc J. 2018 May;20(5):277-280.'}, {'pmid': '30560498', 'type': 'BACKGROUND', 'citation': 'Wang WJ, Li HT, Yu JP, Su L, Guo CA, Chen P, Yan L, Li K, Ma YW, Wang L, Hu W, Li YM, Liu HB. Severity and incidence of complications assessed by the Clavien-Dindo classification following robotic and laparoscopic gastrectomy for advanced gastric cancer: a retrospective and propensity score-matched study. Surg Endosc. 2019 Oct;33(10):3341-3354. doi: 10.1007/s00464-018-06624-7. Epub 2018 Dec 17.'}, {'pmid': '36342574', 'type': 'BACKGROUND', 'citation': 'Japanese Gastric Cancer Association. Japanese Gastric Cancer Treatment Guidelines 2021 (6th edition). Gastric Cancer. 2023 Jan;26(1):1-25. doi: 10.1007/s10120-022-01331-8. Epub 2022 Nov 7.'}, {'pmid': '35523224', 'type': 'BACKGROUND', 'citation': 'Pimentel-Nunes P, Libanio D, Bastiaansen BAJ, Bhandari P, Bisschops R, Bourke MJ, Esposito G, Lemmers A, Maselli R, Messmann H, Pech O, Pioche M, Vieth M, Weusten BLAM, van Hooft JE, Deprez PH, Dinis-Ribeiro M. Endoscopic submucosal dissection for superficial gastrointestinal lesions: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2022. Endoscopy. 2022 Jun;54(6):591-622. doi: 10.1055/a-1811-7025. Epub 2022 May 6.'}, {'pmid': '532187', 'type': 'BACKGROUND', 'citation': 'Murakami T. Early cancer of the stomach. World J Surg. 1979 Nov;3(6):685-92. doi: 10.1007/BF01654788. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'For patients with non-curative resection after endoscopic submucosal dissection (ESD) for early gastric cancer (EGC), complementary surgery is generally recommended. However, about 2/3 of patients have no remaining tumor in the stomach or regional lymph nodes. In this trial, Indocyanine Green (ICG)-guided lymphadenectomy with or without laparoscopic and endoscopic cooperative surgery (LECS) will be tested as a less invasive alternative in such cases. For patients with a primary radically resected EGC, ICG-guided lymphadenectomy alone will be performed. For patients with deep-margin positive EGC, ICG-guided lymphadenectomy and LECS will be performed, in order to ensure both local tumor control in the stomach and in regional nodes.', 'detailedDescription': 'Endoscopic submucosal dissection (ESD) is the recommended treatment for early gastric cancer (EGC) who are fullfillling the criteria based on international guidelines. After ESD, some resections are classified as non-curative because of factors such as non radicality (especially when the deep margin is positive for cancer), lymphovascular invasion or deep submucosal invasion Sm\\>1. In such cases, guidelines recommend complementary gastrectomy and lymphadenectomy. Gastrectomy is known to carry a risk for severe complications in about 9-22 % of cases. Furthermore, up to 2/3 of patients are found to have no remaining tumor in the stomach or regional nodes after surgery.\n\nIn this trial, Indocyanine Green (ICG)-guided lymphadenectomy including sentinel node resection, with or without complementary laparoscopic and endoscopic cooperative surgery (LECS) will be tested as a less invasive treatment option. For patients with radically resected EGC, ICG-guided lymphadenectomy alone will be performed. In patients with deep margin positive EGC, ICG-guided lymphadenectomy and LECS will be performed.\n\nICG-guided lymphadenectomy is performed by first injecting 100 times diluted ICG in four quadrants in the submucosa around the tumor scar with gastroscopy. After 15 minutes, the draining nodes will be visualized with laparoscopy, and locally resected. LECS is performed by endoscopic marking of the scar followed circumferential mucosal cutting, trimming, and perforation of the stomach followed by full-thickness resection of the scar with laparoscopy. After resection, the resected specimen will be taken out and the stomach defect sutured laparoscopically.\n\nAfter the procedure, the patient will be presented at a multidisciplinary tumor board. If only clinical follow-up is recommended, the patient will be followed closely with gastroscopy and computer tomography (CT) scan every 3 months for the first year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* EGC previously treated with ESD according to current guidelines (differentiated adenocarcinoma, not ulcerative, of any size, differentiated adenocarcinoma ulcerative \\</=3cm, undifferentiated adenocarcinoma not ulcerative \\</=2cm)\n* Non curative resection\n\n * Lymphovascular invasion\n * Non-radical resection vertical margin\n * deep submucosal invasion\n* Signed informed consent\n\nExclusion Criteria:\n\n* Location within 2 cm from cardia or pylorus\n* Non-curative resection with only non-radicality horizontal margin\n* Inoperative because of severe comorbidities\n* Previous radiotherapy to the upper abdomen\n* Pregnancy\n* Allergy to ICG\n* Inability to provide informed consent due to cognitive impairment, language barrier, or other reasons impairing understanding and autonomous decision-making.'}, 'identificationModule': {'nctId': 'NCT07295002', 'acronym': 'Co-SNARE', 'briefTitle': 'Sentinel Node Resection With or Without LECS After Noncurative ESD for EGC', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Region Stockholm'}, 'officialTitle': 'COmpletion Sentinel Node Resection With or Without Minimally invAsive and Endoscopic Cooperative Surgery Following noncuRative Endoscopic Submucosal Dissection for Early Gastric Cancer', 'orgStudyIdInfo': {'id': '2025-05956-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ICG-guided lymphadenectomy +/- LECS', 'description': 'Laparoscopic and endoscopic cooperative surgery to locally resect the gastric scar. This method will we be used for cases where pathology showed positive vertical margin after ESD. Otherwise, submucosal injection of ICG in quadrants around the scar after ESD, followed by laparoscopic resection of positive lymph nodes after 15 minutes', 'interventionNames': ['Procedure: ICG-guided lymphadenectomy', 'Procedure: Laparoscopic and endoscopic cooperative surgery (LECS)']}], 'interventions': [{'name': 'ICG-guided lymphadenectomy', 'type': 'PROCEDURE', 'description': 'Submucosal injection of ICG in quadrants around the scar after ESD, followed by laparoscopic resection of positive lymph nodes after 15 minutes', 'armGroupLabels': ['ICG-guided lymphadenectomy +/- LECS']}, {'name': 'Laparoscopic and endoscopic cooperative surgery (LECS)', 'type': 'PROCEDURE', 'description': 'Endoscopic marking and submucosal cutting around the scar after ESD, followed by perforation of the gastric wall and laparoscopic full thickness resection of the area under endoscopic guidance.', 'armGroupLabels': ['ICG-guided lymphadenectomy +/- LECS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '141 57', 'city': 'Stockholm', 'country': 'Sweden', 'contacts': [{'name': 'Ioannis Rouvelas, MD PhD', 'role': 'CONTACT', 'email': 'ioannis.rouvelas@regionstockholm.se', 'phone': '+46707976814'}, {'name': 'Henrik Maltzman, MD', 'role': 'CONTACT', 'email': 'henrik.maltzman@regionstockholm.se', 'phone': '+46706334445'}], 'facility': 'Karolinska University Hospital Huddinge', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'centralContacts': [{'name': 'Ioannis Rouvelas, MD, PhD', 'role': 'CONTACT', 'email': 'ioannis.rouvelas@ki.se', 'phone': '+46707976814'}, {'name': 'Henrik Maltzman, MD', 'role': 'CONTACT', 'email': 'henrik.maltzman@ki.se', 'phone': '+46706334445'}], 'overallOfficials': [{'name': 'Ioannis Rouvelas, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ME Övre buk, Karolinska Universitetssjukhuset'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Stockholm', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, MD, PhD', 'investigatorFullName': 'Ioannis Rouvelas', 'investigatorAffiliation': 'Region Stockholm'}}}}