Back to results

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

Primary Purpose

Early Gastric Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

NESS-EFTR

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 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

Sites / Locations

National Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NESS-EFTR

Arm Description

This arm will be received non-exposure simple suturing endoscopic full-thickness resection after sentinel lymph node navigation

Outcomes

Primary Outcome Measures

Complete resection

single piece resection with clear resection margin

Secondary Outcome Measures

Full Information

NCT ID

NCT03216174

First Posted

July 10, 2017

Last Updated

July 10, 2017

Sponsor

National Cancer Center, Korea

1. Study Identification

Unique Protocol Identification Number

NCT03216174

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 11, 2017 (Anticipated)

Primary Completion Date

December 31, 2017 (Anticipated)

Study Completion Date

June 30, 2018 (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, 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.

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

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NESS-EFTR

Arm Type

Experimental

Arm Description

This arm will be received non-exposure simple suturing endoscopic full-thickness resection after sentinel lymph node navigation

Intervention Type

Procedure

Intervention Name(s)

NESS-EFTR

Intervention Description

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

Primary Outcome Measure Information:

Title

Complete resection

Description

single piece resection with clear resection margin

Time Frame

3 months

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 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

Central Contact Person:

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

Chan Gyoo Kim, M.D.

Phone

+319201620

glse@ncc.re.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chan Gyoo Kim, M.D.

Organizational Affiliation

National Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Center

City

Goyang

State/Province

Gyeonggi

ZIP/Postal Code

410-769

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

33024581

Citation

Eom 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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs