Sentinel Node Resection With or Without LECS After Noncurative ESD for EGC
ConditionEarly Gastric Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Stockholm
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ICG-guided lymphadenectomy
- Laparoscopic and endoscopic cooperative surgery (LECS)
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov