Non-exposure Simple Suturing EFTR (NESS-EFTR) With Laparoscopic Sentinel Lymph Node Navigation for EGC (Senorita3-phase 2)

Study Overview
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Brief Summary
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Laparoscopic sentinel lymph node dissection and stomach preserving surgery in early gastric cancer is less invasive method which can increase quality of life. Current stomach preserving surgery after sentinel lymph node dissection produce transmural communication and expose the tumor to the peritoneum during operation. An endoscopic full-thickness resection method with a simple suturing technique that does not expose the gastric mucosa to the peritoneum (non-exposure simple suturing endoscopic full-thickness resection, NESS-EFTR) was recently developed. This is the phase2 study to identify the efficacy of NESS-EFTR with sentinel node navigation in early gastric cancer patients.

Official Title
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Non-exposure Simple Suturing Endoscopic Full-Thickness Resection (NESS-EFTR) With Laparoscopic Sentinel Lymph Node Navigation for EGC (Senorita3-phase 2)

Conditions
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Early Gastric Cancer

Intervention / Treatment
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* Procedure: NESS-EFTR with sentinel lymph node navigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: single lesion of adenocarcinoma in preoperative endoscopic biopsy clinical stage T1N0 in the preoperative evaluation of endoscopy and computed tomography tumor size: less than 3cm location: 3cm far from the pylorus or cardia aged 20 to 80 ECOG 0 or 1 patient who signed the agreement patient who is suspected to underwent laparoscopy assisted gastrectomy Exclusion Criteria: absolute indication of endoscopic submucosal resection inoperable due to poor cardiac, pulmonary function pregnant having allergic reaction, previous upper abdominal surgery except laparoscopic cholecystectomy, previous radiation therapy to upper abdomen diagnosed as malignancy within 5 years except carcinoma in situ of cervix cancer and thyroid cancer

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NESS-EFTR<br>Non-exposure Simple Suturing Endoscopic Full-Thickness Resection (NESS-EFTR) With Laparoscopic Sentinel Lymph Node Navigation (basin dissection) | Procedure: NESS-EFTR with sentinel lymph node navigation<br>* Non-exposure Simple Suturing Endoscopic Full-Thickness Resection with sentinel lymph node navigation (basin dissection) for early gastric cancer patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete resection rate (%) of tumor | the definition of complete resection is 'Tumor exist in single resected piece (en bloc resection) with clear resection margin'. | 2 weeks |