Sentinel Node Resection With or Without LECS After Noncurative ESD for EGC (Co-SNARE)

COmpletion Sentinel Node Resection With or Without Minimally invAsive and Endoscopic Cooperative Surgery Following noncuRative Endoscopic Submucosal Dissection for Early Gastric Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Early Gastric Cancer
• Intervention / Treatment: Procedure: ICG-guided lymphadenectomy; Procedure: Laparoscopic and endoscopic cooperative surgery (LECS)

Detailed Description

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.

In 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.

ICG-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.

After 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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ioannis Rouvelas, MD, PhD; Phone Number: +46707976814; Email: ioannis.rouvelas@ki.se
• Study Contact Backup: Name: Henrik Maltzman, MD; Phone Number: +46706334445; Email: henrik.maltzman@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden, 141 57
    • Karolinska University Hospital Huddinge
    • Contact: Henrik Maltzman, MD; Phone Number: +46706334445; Email: henrik.maltzman@regionstockholm.se
    • Contact: Ioannis Rouvelas, MD PhD; Phone Number: +46707976814; Email: ioannis.rouvelas@regionstockholm.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ICG-guided lymphadenectomy +/- LECS; 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

Procedure: ICG-guided lymphadenectomy; Submucosal injection of ICG in quadrants around the scar after ESD, followed by laparoscopic resection of positive lymph nodes after 15 minutes; Procedure: Laparoscopic and endoscopic cooperative surgery (LECS); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe complications defined as Clavien-Dindo >/= III	Safety of the procedure, defined as Clavien-Dindo complication grade >/= III	Periprocedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any complications	Any complication during the procedure (Clavien-Dindo II-IV)	Periprocedural
Postoperative bleeding	Postoperative bleeding requiring blood transfusion	Periprocedural
Leakage	Leakage/postoperative abscess requiring drainage	Periprocedural
Operation time	Time of the surgical procedure	Periprocedural
Pathological tumor (T)-stage	Depth of tumor invasion into the gastric wall (for LECS cases)	Up to 2 months post procedure
Tumor-free resection margins	The rate of horizontal and vertical margins free of tumor cells (for LECS cases).	Up to 2 months post procedure
Number of lymph nodes	Number of lymph nodes harvested during the procedure	Periprocedural
Number of positive lymph nodes	Number of lymph nodes positive for cancer	Up to 2 months post procedure
Hospital-stay	Number of days from the procedure until discharge	From the day of the procedure until patient is discharged from the hospital, assessed up to 12 weeks post procedure
Health-related quality of life (HQL) score QLQ-30	Pre and postoperative HQL, tested with the validated score QLQ-C30 (The EORTC QLG Core Questionnaire for cancer patients)	Preoperatively, after 30 days and 1 year
Health-related quality of life (HQL) score OG25	Pre and postoperative HQL, tested with the validated score OG25 (The EORTC QLG Module Questionnaire specifically for esophago-gastric patients)	Preoperatively, after 30 days and 1 year
30-day mortality	30-day mortality	From procedure to maximum 30 days postoperatively
In-hospital mortality	In-hospital mortality	From the day of the procedure until patient is discharged from the hospital, assessed up to 12 weeks post procedure
1-year disease-free survival	1-year disease-free survival	Until 1 year after the procedure

Collaborators and Investigators

• Sponsor: Region Stockholm
• Investigators: Principal Investigator: Ioannis Rouvelas, MD, PhD, ME Övre buk, Karolinska Universitetssjukhuset

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Murakami T. Early cancer of the stomach. World J Surg. 1979 Nov;3(6):685-92. doi: 10.1007/BF01654788. No abstract available.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: November 15, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: minimal invasive surgery; sentinel node-resection
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy; Laparoscopy
• Other Study ID Numbers: 2025-05956-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No