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

Phase 2

• Conditions: Early Gastric Cancer
• Interventions: Procedure: NESS-EFTR with sentinel lymph node navigation

• Registration Number: NCT03837301
• Lead Sponsor: National Cancer Center, Korea

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-12
• Status Verified: 2019-02
• Study First Submitted: 2019-02-03
• Study First Submitted QC: 2019-02-09
• Last Update Submitted: 2019-02-09
• Study First Posted: 2019-02-12
• Last Update Posted: 2019-02-12
• Primary Completion: 2019-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NESS-EFTR	NESS-EFTR with sentinel lymph node navigation	Non-exposure Simple Suturing Endoscopic Full-Thickness Resection (NESS-EFTR) With Laparoscopic Sentinel Lymph Node Navigation (basin dissection)

Primary Outcome Measures

Name	Time	Method
complete resection rate (%) of tumor	2 weeks	the definition of complete resection is 'Tumor exist in single resected piece (en bloc resection) with clear resection margin'.

Trial Locations

Locations (1)

National Cancer Center; 🇰🇷 Goyang, Korea, Republic of