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

Sponsor
National Cancer Center, Korea (Other)
Overall Status
Unknown status
CT.gov ID
NCT03216174
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
11.6
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: NESS-EFTR
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pilot Study of Non-exposure Simple Suturing EFTR (NESS-EFTR) With Sentinel Lymph Node Navigation for Early Gastric Cancer (Senorita3-pilot)
Anticipated Study Start Date :
Jul 11, 2017
Anticipated Primary Completion Date :
Dec 31, 2017
Anticipated Study Completion Date :
Jun 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: NESS-EFTR

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

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.

Outcome Measures

Primary Outcome Measures

  1. Complete resection [3 months]

    single piece resection with clear resection margin

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Cancer Center Goyang Gyeonggi Korea, Republic of 410-769

Sponsors and Collaborators

  • National Cancer Center, Korea

Investigators

  • Principal Investigator: Chan Gyoo Kim, M.D., National Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chan Gyoo Kim, Senior scientist, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT03216174
Other Study ID Numbers:
  • NCC2017-0088
First Posted:
Jul 13, 2017
Last Update Posted:
Jul 13, 2017
Last Verified:
Jul 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Stomach Neoplasms

Study Results

No Results Posted as of Jul 13, 2017