NCT01804998

Brief Summary

Laparoscopic sentinel lymph node biopsy and stomach preserving surgery in early gastric cancer is less invasive method which can increase quality of life. For last two years, multicenter quality control study (Phase II) has been performed in Korea and tolerable results were observed. Based on these results, multicenter phase III trial is required to validate the clinical role of laparoscopic sentinel lymph node biopsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
580

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

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

March 4, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2013

Completed
22 days until next milestone

Study Start

First participant enrolled

March 27, 2013

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2021

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

6.8 years

First QC Date

March 4, 2013

Last Update Submit

February 13, 2022

Conditions

Early Gastric Cancer

Keywords

laparoscopic sentinel lymph node biopsyphase 3early gastric cancer

Outcome Measures

Primary Outcomes (1)

  • 3 year disease free survival rate

    A total of enrollment period is suspected to be four years and patients will be followed up for five years. However, primary end point is 3 year disease free survival and we can analyze survival data at three year later from when the last enrolled patients underwent intervention.

    3 years after surgery

Secondary Outcomes (9)

  • postoperative morbidity and mortality

    30 days after surgery

  • scores of global health status scale, functional scales, and symptom scales/items of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30 and STO22

    3 years

  • 5 year disease free survival rate

    5 years after surgery

  • 5 year overall survival rate

    5 years after surgery

  • 3 year recurrence free survival rate

    3 years after surgery

  • +4 more secondary outcomes

Study Arms (2)

Laparoscopic Sentinel Node Biopsy

EXPERIMENTAL

Laparoscopic Sentinel Node Biopsy or Stomach Preserving Surgery could be performed in this arm

Procedure: Laparoscopic Sentinel Node Biopsy

Laparoscopy Assisted Gastrectomy

ACTIVE COMPARATOR

Conventional procedure is laparoscopy assisted gastrectomy in early gastric cancer patient.

Procedure: Laparoscopy Assisted Gastrectomy

Interventions

Laparoscopic Sentinel Node BiopsyPROCEDURE

Laparoscopic Sentinel Node Biopsy or Stomach Preserving Surgery could be performed in the experimental arm.

Laparoscopic Sentinel Node Biopsy
Laparoscopy Assisted GastrectomyPROCEDURE

In the control arm, laparoscopy assisted gastrectomy with lymph node dissection (D1+ or more) will be performed.

Laparoscopy Assisted Gastrectomy

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
  • 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 (7)

Chonnam National University Hwasun Hospital

Hwasun, Chonnam, South Korea

Location

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Location

Soonchunhyang University Bucheon Hospital

Bucheon-si, South Korea

Location

Dongnam Institute of Radiological and Medical Science

Busan, South Korea

Location

Gyeongsang National University

Jinju, South Korea

Location

Yonsei Univeristy College of Medicine

Seoul, South Korea

Location

Ajou University School of Medicine

Suwon, South Korea

Location

Related Publications (4)

  • Eom BW, Yoon HM, Kim YW, Min JS, An JY, Hur H, Lee YJ, Cho GS, Park YK, Jung MR, Park JH, Hyung WJ, Jeong SH, Kook MC, Han M, Nam BH, Ryu KW; Sentinel Node Oriented Tailored Approach (SENORITA) Study Group. Quality of Life and Nutritional Outcomes of Stomach-Preserving Surgery for Early Gastric Cancer: A Secondary Analysis of the SENORITA Randomized Clinical Trial. JAMA Surg. 2024 Aug 1;159(8):900-908. doi: 10.1001/jamasurg.2024.1210.

    PMID: 38809537DERIVED

  • Kim YW, Min JS, Yoon HM, An JY, Eom BW, Hur H, Lee YJ, Cho GS, Park YK, Jung MR, Park JH, Hyung WJ, Jeong SH, Kook MC, Han M, Nam BH, Ryu KW. Laparoscopic Sentinel Node Navigation Surgery for Stomach Preservation in Patients With Early Gastric Cancer: A Randomized Clinical Trial. J Clin Oncol. 2022 Jul 20;40(21):2342-2351. doi: 10.1200/JCO.21.02242. Epub 2022 Mar 24.

    PMID: 35324317DERIVED

  • An JY, Min JS, Hur H, Lee YJ, Cho GS, Park YK, Jung MR, Park JH, Hyung WJ, Jeong SH, Kim YW, Yoon HM, Eom BW, Kook MC, Han MR, Nam BH, Ryu KW; SEntinel Node ORIented Tailored Approach (SENORITA) Study Group. Laparoscopic sentinel node navigation surgery versus laparoscopic gastrectomy with lymph node dissection for early gastric cancer: short-term outcomes of a multicentre randomized controlled trial (SENORITA). Br J Surg. 2020 Oct;107(11):1429-1439. doi: 10.1002/bjs.11655. Epub 2020 Jun 3.

    PMID: 32492186DERIVED

  • Park JY, Kim YW, Ryu KW, Nam BH, Lee YJ, Jeong SH, Park JH, Hur H, Han SU, Min JS, An JY, Hyung WJ, Cho GS, Jeong GA, Jeong O, Park YK, Jung MR, Yoon HM, Eom BW. Assessment of laparoscopic stomach preserving surgery with sentinel basin dissection versus standard gastrectomy with lymphadenectomy in early gastric cancer-A multicenter randomized phase III clinical trial (SENORITA trial) protocol. BMC Cancer. 2016 May 31;16:340. doi: 10.1186/s12885-016-2336-8.

    PMID: 27246120DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Stomach preserving surgery after laparoscopic sentinel node dissection and evaluation
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 4, 2013

First Posted

March 5, 2013

Study Start

March 27, 2013

Primary Completion

January 15, 2020

Study Completion

December 21, 2021

Last Updated

February 15, 2022

Record last verified: 2022-02

Locations

KR(7)