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NOT YET RECRUITING
NCT07295002
NA

Sentinel Node Resection With or Without LECS After Noncurative ESD for EGC

Sponsor: Region Stockholm

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2026-01-01

Completion Date

2029-10-01

Last Updated

2025-12-19

Healthy Volunteers

No

Interventions

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.

Locations (1)

Karolinska University Hospital Huddinge

Stockholm, Sweden