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

Region Stockholm

Status: Not yet enrolling

Conditions: Early Gastric Cancer

Treatments: Procedure: Laparoscopic and endoscopic cooperative surgery (LECS); Procedure: ICG-guided lymphadenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07295002

2025-05956-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

ICG-guided lymphadenectomy +/- LECS

Experimental group

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

Treatment:

Procedure: ICG-guided lymphadenectomy

Procedure: Laparoscopic and endoscopic cooperative surgery (LECS)