Clinical trial · Interventional
Sentinel Node Resection With or Without LECS After Noncurative ESD for EGC
COmpletion Sentinel Node Resection With or Without Minimally invAsive and Endoscopic Cooperative Surgery Following noncuRative Endoscopic Submucosal Dissection for Early Gastric Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Gastric Cancer | Early Gastric Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICG-guided lymphadenectomy | Procedure | — | UNRESOLVED |
| Laparoscopic and endoscopic cooperative surgery (LECS) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- 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)
Primary outcomes (1)
- measure
- Severe complications defined as Clavien-Dindo >/= III
- timeFrame
- Periprocedural
- description
- Safety of the procedure, defined as Clavien-Dindo complication grade \>/= III
Secondary outcomes (14)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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) * Non curative resection * Lymphovascular invasion * Non-radical resection vertical margin * deep submucosal invasion * Signed informed consent Exclusion Criteria: * Location within 2 cm from cardia or pylorus * Non-curative resection with only non-radicality horizontal margin * Inoperative because of severe comorbidities * Previous radiotherapy to the upper abdomen * Pregnancy * Allergy to ICG * Inability to provide informed consent due to cognitive impairment, language barrier, or other reasons impairing understanding and autonomous decision-making.
References
Publications (9)
- BACKGROUNDBelia 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 35836598
- BACKGROUNDMorais 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 37666656
- BACKGROUNDvan 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 32818901
- BACKGROUNDTsekrekos 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 36808262
- BACKGROUNDNevo 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 29761671