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

Early Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03837301
• Other study ID #: NCC2018-0162
• Status: Recruiting
• Phase: Phase 2
• Start date: September 12, 2018
• Est. completion date: December 2021

Study information

• Verified date: February 2019
• Source: National Cancer Center, Korea
• Contact: Chan G Kim, M.D.
• Phone: +82319201120
• Email: glse[@]ncc.re.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: December 2021
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Early Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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