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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03837301
Other study ID # NCC2018-0162
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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