NCT05978882

Brief Summary

SENORITA 1 trial showed laparoscopic sentinel lymph node biopsy and stomach preserving surgery in early gastric cancer can increase the quality of life. (Ryu KW et al. JCO 2022) The radioactive isotope is difficult to use because of the hazard of radiation and shortage of materials. The aim of this study is to investigate whether laparoscopic sentinel lymph node biopsy and stomach-preserving surgery using only fluorescence is feasible.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
203

participants targeted

Target at P75+ for not_applicable

Timeline
57mo left

Started Aug 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
not yet recruiting

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

Study Progress37%
Aug 2023Dec 2030

First Submitted

Initial submission to the registry

July 20, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

August 17, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected
Last Updated

August 7, 2023

Status Verified

July 1, 2023

Enrollment Period

2.4 years

First QC Date

July 20, 2023

Last Update Submit

July 31, 2023

Conditions

Early Gastric Cancer

Keywords

Early gastric cancerSentinel lymph nodeFluorescenceStomach-preserving surgeryQuality of life

Outcome Measures

Primary Outcomes (1)

  • Detection rate of Sentinel lymph nodes

    number of patients whose sentinel nodes are detected / enrolled number of patients \*100

    15 days after operation

Secondary Outcomes (9)

  • 3 year disease free survival

    3 year after surgery

  • 3 year overall survival rate

    3 year after surgery

  • 3 year disease specific death rate

    3 year after surgery

  • 3 year recurrence free survival rate

    3 year 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

    5 years

  • +4 more secondary outcomes

Study Arms (1)

Laparoscopic sentinel navigation surgery

EXPERIMENTAL

compare the detection rate of sentinel lymph nodes to that of previous study (SENORITA1 trial)

Procedure: Laparoscopic sentinel navigation surgery using fluorescence

Interventions

Laparoscopic sentinel navigation surgery using fluorescencePROCEDURE

If the frozen biopsy of sentinel lymph nodes are all negative using fluorescence, stomach-preserving surgery is performed

Laparoscopic sentinel navigation surgery

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 laparoscopic or robotic gastrectomy

You may not qualify if:

  • indication of endoscopic submucosal resection
  • inoperable due to poor cardiac, and 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)

Dongnam Inst. of Radiological & Medical Science

Busan, Gijang-gun, 46033, South Korea

Location

Gyeongsang National University Hospital

Gyeongsang, Gingu-si, 52727, South Korea

Location

Sevrance Hospital

Seoul, Sinchon, 03722, South Korea

Location

Ajou University Medical Center

Gyeonggi-do, Suwon-si, 16499, South Korea

Location

Gyeongsang National University Changwon Hospital

Changwon, 51472, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Soon Chun Hyang University Hospital Bucheon

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Hong Man Yoon, MD

CONTACT

+82-31-920-1710red10000@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
MD

Study Record Dates

First Submitted

July 20, 2023

First Posted

August 7, 2023

Study Start

August 17, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2030

Last Updated

August 7, 2023

Record last verified: 2023-07

Locations

KR(7)