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

Primary Purpose

Early Gastric Cancer

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

NESS-EFTR with sentinel lymph node navigation

About this trial

This is an interventional treatment trial for Early Gastric Cancer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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
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

Sites / Locations

National Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NESS-EFTR

Arm Description

Non-exposure Simple Suturing Endoscopic Full-Thickness Resection (NESS-EFTR) With Laparoscopic Sentinel Lymph Node Navigation (basin dissection)

Outcomes

Primary Outcome Measures

complete resection rate (%) of tumor

the definition of complete resection is 'Tumor exist in single resected piece (en bloc resection) with clear resection margin'.

Secondary Outcome Measures

Full Information

NCT ID

NCT03837301

First Posted

February 3, 2019

Last Updated

February 9, 2019

Sponsor

National Cancer Center, Korea

1. Study Identification

Unique Protocol Identification Number

NCT03837301

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

September 12, 2018 (Actual)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Cancer Center, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Early Gastric Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NESS-EFTR

Arm Type

Experimental

Arm Description

Non-exposure Simple Suturing Endoscopic Full-Thickness Resection (NESS-EFTR) With Laparoscopic Sentinel Lymph Node Navigation (basin dissection)

Intervention Type

Procedure

Intervention Name(s)

NESS-EFTR with sentinel lymph node navigation

Intervention Description

Non-exposure Simple Suturing Endoscopic Full-Thickness Resection with sentinel lymph node navigation (basin dissection) for early gastric cancer patients

Primary Outcome Measure Information:

Title

complete resection rate (%) of tumor

Description

the definition of complete resection is 'Tumor exist in single resected piece (en bloc resection) with clear resection margin'.

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chan G Kim, M.D.

Phone

+82319201120

glse@ncc.re.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chan G Kim, M.D.

Organizational Affiliation

National Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Center

City

Goyang

ZIP/Postal Code

10408

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chan G Kim, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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