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

NCT ID: NCT03837301

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-12
• Study Completion Date: 2021-12-31

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.

Conditions

Early Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NESS-EFTR

Non-exposure Simple Suturing Endoscopic Full-Thickness Resection (NESS-EFTR) With Laparoscopic Sentinel Lymph Node Navigation (basin dissection)

Group Type: EXPERIMENTAL

NESS-EFTR with sentinel lymph node navigation

Intervention Type: PROCEDURE

Non-exposure Simple Suturing Endoscopic Full-Thickness Resection with sentinel lymph node navigation (basin dissection) for early gastric cancer patients

Interventions

NESS-EFTR with sentinel lymph node navigation

Non-exposure Simple Suturing Endoscopic Full-Thickness Resection with sentinel lymph node navigation (basin dissection) for early gastric cancer patients

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

Chan Gyoo Kim

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chan G Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center

Locations

National Cancer Center

Goyang, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Chan G Kim, M.D.

Role: CONTACT

glse@ncc.re.kr

+82319201120

Facility Contacts

Chan G Kim, M.D.

Role: primary

Other Identifiers

NCC2018-0162

Identifier Type: -

Identifier Source: org_study_id