Sentinel Lymph NodeSENORITA2NCT03123042
Feasibility Study of Sentinel Navigation Surgery After Non-curative Endoscopic Resection
A study testing Sentinel basin dissection in people with Sentinel Lymph Node and Early Gastric Cancer, run by National Cancer Center, Korea at 9 sites in South Korea.
Trial summary
Purpose: To prove the feasibility of sentinel node navigation surgery (SNNS) in early gastric cancer patients with the risk of lymph node metastasis after endoscopic resection and preparation of multicenter phase 3 trial of stomach preserving surgery in these patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sentinel Lymph Node, Early Gastric Cancer
- What is being tested?
- Sentinel basin dissection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 9 sitesSouth Korea
- Study dates
- 20 Mar 2017to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- No limitation for age if the patient is available for gastrectomy
- Patient who underwent endoscopic submucosal dissection and the tumor was defined as out of indication.
- The expanded criteria for endoscopic resection are as follows
- criterion I: intramucosal tumor without ulcerative findings and of differentiated type with size > 2 cm
- criterion II: intramucosal tumor with ulcerative findings and of differentiated type with size ≤ 3 cm
- criterion III: intramucosal tumor without ulcerative findings and of undifferentiated type with size < 2 cm
- criterion IV, submucosal invasion < 500 mm and of differentiated type with size ≤ 3 cm)
- Eastern Cooperative Oncology Group (ECOG) performance scale 0 or 1
Who cannot join
- Inoperative due to severe cardiovascular or pulmonary disease
- Pregnant
- Patients who had previous gastric surgery
- Patients who had previous upper abdomen surgery except cholecystectomy, or radiation therapy on upper abdomen, or hypersensitivity to any medicine
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Soonchunhyang University College of Medicine
Bucheon-si
Dongnam Institute of Radiological and Medical Science
Busan
Gyeongsang National University Changwon Hospital
Changwon
Kyungpook National University Medical Center
Daegu
Bang Wool Eom
Goyang-si, Gyeonggi-do, 10408
Chonnam National University Hwasun Hospital
Hwasun
Gyeongsang National University Hospital
Jinju
Samsung Medical Center
Seoul
Ajou University School of Medicine
Suwon
About this study
Official title: Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Patients After Non-curative Endoscopic Resection
Purpose: To prove the feasibility of sentinel node navigation surgery (SNNS) in early gastric cancer patients with the risk of lymph node metastasis after endoscopic resection and preparation of multicenter phase 3 trial of stomach preserving surgery in these patients.
Contents: The number of enrollment is 247 patients. The patients underwent endoscopic resection for early gastric cancer, and the tumor was defined to be out of indication for endoscopic resection pathologically. So, additional gastrectomy is recommended for them.
The investigators will enroll patients who agree this study. After general anesthesia, Tc99m-Phytate with indocyanine green will be injected with endoscopy. Then sentinel basin will be detected using gamma probe and laparoscopic basin dissection will be done. Sentinel lymph node will be identify in back table dissection, and patients will undergo conventional gastrectomy. Detection rate and false negative rate will be evaluated by pathological review.
Read the detailed description
Sentinel basin dissection method
- endoscopic tracer injection after general anesthesia
- Tracer : Tc99m-phytate 3cc and indocyanine green 3cc mix --> Injection of the probe (1cc/site, 4 sites) around endoscopic submucosal dissection ulcer scar
- Sentinel basin identification with laparoscopic probe
- Dissection of the sentinel basin
- Sentinel node dissection at back table
- Conventional laparoscopic gastrectomy
- Conditions
- Sentinel Lymph Node, Early Gastric Cancer
- Being tested
- Sentinel basin dissection
- Keywords
- Sentinel lymph node, Early gastric cancer, Non-curative endoscopic resection
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel basin dissectionProcedure or surgery
Sentinel basin detection using endoscopic detector (Tc99m plus indocyanine green) injection and laparoscopic sentinel basin dissection. Then conventional gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Sentinel basin dissection | Experimental | Intervention: Sentinel basin dissection Receives: Procedure: Sentinel basin dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection rate (%)
number of patients whose sentinel nodes are detected / enrolled number of patients *100
Measured: 15 days after operation
Secondary outcomes (1)
False negative rate
number of patients without metastatic lymph node in sentinel basin / number of patients with metastatic lymph node *100
Measured: 15 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start20 Mar 2017
- Primary completion21 Nov 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sentinel Lymph NodeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bang Wool Eom, National Cancer Center, Korea
- Investigators
- Bang Wool Eom, MD, PhD, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123042
- Sponsor's protocol ID
- 1710162
- Acronym
- SENORITA2
- Status last verified
- Mar 2025
- First submitted
- 10 Apr 2017
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eom BW, Yoon HM, Min JS, Cho I, Park JH, Jung MR, Hur H, Kim YW, Park YK, Nam BH, Ryu KW; Sentinel Node Oriented Tailored Approach (SENORITA) Study Group. Prospective Multicenter Feasibility Study of Laparoscopic Sentinel Basin Dissection after Endoscopic Submucosal Dissection for Early Gastric Cancer: SENORITA 2 Trial Protocol. J Gastric Cancer. 2019 Jun;19(2):157-164. doi: 10.5230/jgc.2019.19.e12. Epub 2019 Apr 15.
PubMed 31245160
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Patients After Non-curative Endoscopic Resection
- ClinicalTrials.gov ID
- NCT03123042
- Acronym / sponsor ID
- SENORITA2 / 1710162
- Conditions
- Sentinel Lymph Node, Early Gastric Cancer
- Keywords
- Sentinel lymph node, Early gastric cancer, Non-curative endoscopic resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 21 Nov 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: To prove the feasibility of sentinel node navigation surgery (SNNS) in early gastric cancer patients with the risk of lymph node metastasis after endoscopic resection and preparation of multicenter phase 3 trial of stomach preserving surgery in these patients.
Contents: The number of enrollment is 247 patients. The patients underwent endoscopic resection for early gastric cancer, and the tumor was defined to be out of indication for endoscopic resection pathologically. So, additional gastrectomy is recommended for them.
The investigators will enroll patients who agree this study. After general anesthesia, Tc99m-Phytate with indocyanine green will be injected with endoscopy. Then sentinel basin will be detected using gamma probe and laparoscopic basin dissection will be done. Sentinel lymph node will be identify in back table dissection, and patients will undergo conventional gastrectomy. Detection rate and false negative rate will be evaluated by pathological review.
Detailed description
Sentinel basin dissection method
- endoscopic tracer injection after general anesthesia
- Tracer : Tc99m-phytate 3cc and indocyanine green 3cc mix --> Injection of the probe (1cc/site, 4 sites) around endoscopic submucosal dissection ulcer scar
- Sentinel basin identification with laparoscopic probe
- Dissection of the sentinel basin
- Sentinel node dissection at back table
- Conventional laparoscopic gastrectomy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sentinel basin dissection | Experimental | Procedure: Sentinel basin dissectionIntervention: Sentinel basin dissection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- No limitation for age if the patient is available for gastrectomy
- Patient who underwent endoscopic submucosal dissection and the tumor was defined as out of indication.
- The expanded criteria for endoscopic resection are as follows
- criterion I: intramucosal tumor without ulcerative findings and of differentiated type with size > 2 cm
- criterion II: intramucosal tumor with ulcerative findings and of differentiated type with size ≤ 3 cm
Key exclusion criteria (4 listed)
- Inoperative due to severe cardiovascular or pulmonary disease
- Pregnant
- Patients who had previous gastric surgery
- Patients who had previous upper abdomen surgery except cholecystectomy, or radiation therapy on upper abdomen, or hypersensitivity to any medicine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentinel basin dissectionSentinel basin detection using endoscopic detector (Tc99m plus indocyanine green) injection and laparoscopic sentinel basin dissection. Then conventional gastrectomy | Procedure or surgery | Sentinel basin dissection |
Primary outcome
detection rate (%)
Time frame: 15 days after operation
number of patients whose sentinel nodes are detected / enrolled number of patients *100
1 secondary outcome
False negative rate
Time frame: 15 days after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Derived from this study: PubMed 31245160Eom BW, Yoon HM, Min JS, Cho I, Park JH, Jung MR, Hur H, Kim YW, Park YK, Nam BH, Ryu KW; Sentinel Node Oriented Tailored Approach (SENORITA) Study Group. Prospective Multicenter Feasibility Study of Laparoscopic Sentinel Basin Dissection after Endoscopic Submucosal Dissection for Early Gastric Cancer: SENORITA 2 Trial Protocol. J Gastric Cancer. 2019 Jun;19(2):157-164. doi: 10.5230/jgc.2019.19.e12. Epub 2019 Apr 15.
- Individual participant dataSharing planned: No
Related trials for Sentinel Lymph Node
Recruiting
Sentinel lympH Node Biopsy With Indocyanine Green in Breast Cancer After NEoadjuvant Chemotherapy (SHINE)
Breast Cancer
RecruitingEarly Phase 1
Indocyanine Green (ICG) Guided Sentinel Lymph Node Mapping for Pediatric Visceral Solid Tumors
Solid Tumor
RecruitingObservational study
Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery
Breast Cancer, Axillary Lymph Nodes Dissection
Recruiting
The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema
Lymphedema, Breast Cancer
Not yet recruiting
Feasibility and Effectiveness of Sentinel Lymph Node Biopsy in Inflammatory Breast Cancer
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bang Wool Eom, MD, PhD principal investigator
National Cancer Center, Korea
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel basin dissection in people with Sentinel Lymph Node and Early Gastric Cancer, run by National Cancer Center, Korea at 9 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection rate (%) (time frame: 15 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03123042, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.