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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03837301

Enrollment

Registered

2019-02-12

Start date

2018-09-12

Completion date

2021-12-31

Last updated

2019-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Gastric Cancer

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.

Interventions

PROCEDURENESS-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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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'.

Countries

South Korea

Contacts

Primary ContactChan G Kim, M.D.

glse@ncc.re.kr+82319201120

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026