Pilot Study of Non-exposure Simple Suturing EFTR With Sentinel Lymph Node Navigation for EGC (Senorita3-pilot)

Pilot Study of Non-exposure Simple Suturing EFTR (NESS-EFTR) With Sentinel Lymph Node Navigation for Early Gastric Cancer (Senorita3-pilot)

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03216174

Enrollment

Registered

2017-07-13

Start date

2017-07-11

Completion date

2018-06-30

Last updated

2017-07-13

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, NESS) was recently developed. This is the pilot study to prove the feasibility of NESS-EFTR with sentinel node navigation in early gastric cancer patients.

Interventions

PROCEDURENESS-EFTR

NESS-EFTR includes steps of laparoscopic seromuscular suturing, EFTR of the inverted stomach wall, and endoscopic mucosal suturing with endoloops and clips.

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 in differentiated type, less than 2cm in undifferentiated type * location: 2cm 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

* 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	3 months	single piece resection with clear resection margin

Countries

South Korea

Contacts

Primary ContactChan Gyoo Kim, M.D.

glse@ncc.re.kr+319201620

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026