Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Gastric Cancer | Early Gastric Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NESS-EFTR | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NESS-EFTR
- description
- This arm will be received non-exposure simple suturing endoscopic full-thickness resection after sentinel lymph node navigation
- interventionNames
- Procedure: NESS-EFTR
Primary outcomes (1)
- measure
- Complete resection
- timeFrame
- 3 months
- description
- single piece resection with clear resection margin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDEom BW, Kim CG, Kook MC, Yoon HM, Ryu KW, Kim YW, Rho JY, Kim YI, Lee JY, Choi IJ. Non-exposure Simple Suturing Endoscopic Full-thickness Resection with Sentinel Basin Dissection in Patients with Early Gastric Cancer: the SENORITA 3 Pilot Study. J Gastric Cancer. 2020 Sep;20(3):245-255. doi: 10.5230/jgc.2020.20.e22. Epub 2020 Jul 6. PMID 33024581