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

Early Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03216174
• Other study ID #: NCC2017-0088
• Status: Not yet recruiting
• Phase: N/A
• First received: July 10, 2017
• Last updated: July 10, 2017
• Start date: July 11, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: July 2017
• Source: National Cancer Center, Korea
• Contact: Chan Gyoo Kim, M.D.
• Phone: +319201620
• 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, 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 30, 2018
• Est. primary completion date: December 31, 2017
• 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 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

Related Conditions & MeSH terms

• Early Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

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

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	single piece resection with clear resection margin	3 months