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LECS Combined With LSNNS for Early Gastric Cancer (LENS Trial)

Recruitingn/aAges 20 Years - 80 YearsAllPeking University People's Hospital
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In plain words

What the trial is, and whether it could suit you

Early gastric cancer (EGC) is traditionally treated with either endoscopic resection or standard laparoscopic gastrectomy with formal lymph node dissection. However, endoscopic resection cannot evaluate or treat regional lymph node metastasis, whereas standard surgery significantly impairs postoperative gastric physiological function and patient quality of life (QoL). The LENS trial is a prospective, single-arm clinical study designed to evaluate the feasibility, safety, and long-term efficacy of Laparoscopic and Endoscopic Cooperative Surgery (LECS) combined with Laparoscopic Sentinel Node Navigation Surgery (LSNNS) using Indocyanine Green (ICG) fluorescence tracing for patients with cT1N0M0 early gastric cancer. In this trial, eligible patients will undergo intraoperative sentinel lymph node (SN) biopsy guided by ICG. Patients with negative SN status will receive stomach-preserving sur

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Preoperative biopsy confirming solitary lesion of gastric adenocarcinoma * Preoperative magnifying endoscopy diagnosis of differentiated T1b (\> 3 cm) or undifferentiated T1b * Scheduled to undergo laparoscopic surgery * Age between 20 and 80 years * ECOG performance status of 0 or 1 * Signed written informed consent to participate in this clinical study Exclusion Criteria: * Suitable for endoscopic treatment (e.g., standard ESD indications) * Unsuitable for surgery due to severe comorbidities (such as severe cardiopulmonary diseases) * Pregnant women * Known history of allergy to Indocyanine Green (ICG) * Prior history of upper abdominal surgery (except laparoscopic cholecystectomy) * Prior history of upper abdominal radiation therapy * Coexistence of other malignant tumors within the past 5 years
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What it tests

  • Procedure: LECS combined with LSNNS
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Where

1 site
Peking University People's Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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