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

National Cancer Center (NCC)

Status and phase

Unknown

Phase 2

Conditions

Early Gastric Cancer

Treatments

Procedure: NESS-EFTR with sentinel lymph node navigation

Study type

Interventional

Funder types

Other

Identifiers

NCT03837301

NCC2018-0162

Details and patient eligibility

About

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.

Enrollment

88 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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