NCT03216174

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

July 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

6 months

First QC Date

July 10, 2017

Last Update Submit

July 10, 2017

Conditions

Early Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Complete resection

    single piece resection with clear resection margin

    3 months

Study Arms (1)

NESS-EFTR

EXPERIMENTAL

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

Procedure: NESS-EFTR

Interventions

NESS-EFTRPROCEDURE

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

NESS-EFTR

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 33024581DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Chan Gyoo Kim, M.D.

    National Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chan Gyoo Kim, M.D.

CONTACT

+319201620glse@ncc.re.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior scientist

Study Record Dates

First Submitted

July 10, 2017

First Posted

July 13, 2017

Study Start

July 11, 2017

Primary Completion

December 31, 2017

Study Completion

June 30, 2018

Last Updated

July 13, 2017

Record last verified: 2017-07

Locations

KR(1)