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

NCT03837301 | Unknown Phase 2

• 1 other identifier: NCC2018-0162
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

NESS-EFTR

EXPERIMENTAL

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

Interventions

NESS-EFTR with sentinel lymph node navigation PROCEDURE

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

NESS-EFTR

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center

Goyang, 10408, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Chan G Kim, M.D.

  National Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chan G Kim, M.D.

CONTACT

+82319201120; glse@ncc.re.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 3, 2019
• First Posted: February 12, 2019
• Study Start: September 12, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2021
• Last Updated: February 12, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)