Gastric CancerPhase 2SNNSNCT01441310
Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer
A Phase 2 study testing Laparoscopic sentinel node navigation surgery in people with Gastric Cancer, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
There are few reports on a dual dye and isotope approach using laparoscopy in gastric cancer sentinel node mapping. The aim of this study was to evaluate the feasibility of laparoscopic limited gastrectomy with sentinel basin(SB) dissection for gastric cancer using simultaneous indocyanine green (ICG) and… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Laparoscopic sentinel node navigation surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2010to Aug 2016
- Phase
- Phase 2
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20-80
- Informed consent
- No other malignancies
- cT1N0 stage gastric cancers < 4cm
- no allergic history of isotope
Who cannot join
- Patients eligible for endoscopic submucosal dissection(ESD) with absolute indication
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
About this study
There are few reports on a dual dye and isotope approach using laparoscopy in gastric cancer sentinel node mapping.
The aim of this study was to evaluate the feasibility of laparoscopic limited gastrectomy with sentinel basin(SB) dissection for gastric cancer using simultaneous indocyanine green (ICG) and 99mTc-antimony sulfur colloid (ASC) injections.
Read the detailed description
Prospective phase II clinical trials for sentinel node navigation surgery(SNNS) in early gastric cancer.
Laparoscopic SNNS:
- ICG and 99mTc-antimony sulfur colloid (ASC) submucosal injection under intraoperative endoscopy
- Sentinel node basin identification and dissection
- Sentinel nodes picking in back table
- Frozen biopsy of sentinel nodes(hematoxylin and eosin staining and immunohistochemistry for cytokeratin)
- If the sentinel node biopsy by frozen section is negative, limited gastrectomy will be performed or if positive, radical D2 gastrectomy will be performed.
Sample size: 100 cases
Study duration: 5 years( 2year enrollment, 3 year follow-up)
- Conditions
- Gastric Cancer
- Being tested
- Laparoscopic sentinel node navigation surgery
- Keywords
- Gastric cancer, Sentinel node navigation surgery, Dual method, Recurrence
- Medical subject headings
- Stomach Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic sentinel node navigation surgeryProcedure or surgery
Laparoscopic SNNS using simultaneous indocyanine green (ICG) and 99mTc-antimony sulfur colloid (ASC) injections
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic sentinel node navigation surgery | Experimental | Laparoscopic sentinel node navigation surgery Receives: Procedure: Laparoscopic sentinel node navigation surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 Year disease free survival
Recurrence evaluation by eddoscopy, computed tomography and Positron emission tomography if needed.
Measured: Postoperative 3 year
Secondary outcomes (1)
Sentinel node detection rate, occurrence of complication ,Qualtity of life and remnant stomach function evaluation.
Sentinel node detection rate and occurrence of complication of SNNS using dual method for gastric cancer were evaluated QoL questennaire and remnant stomach function were evaluated for the evaluation of patient's quality of life
Measured: postoperative 1, 3, 6, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2011 (estimated)
- Study startJul 2010
- Primary completionAug 2013
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyung-Ho Kim, Seoul National University Bundang Hospital
- Investigators
- Hyung-Ho Kim, M.D.Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441310
- Sponsor's protocol ID
- SNUBHGS01
- Acronym
- SNNS
- Status last verified
- Jan 2017
- First submitted
- 25 Sep 2011
- Last updated
- 9 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer
- ClinicalTrials.gov ID
- NCT01441310
- Acronym / sponsor ID
- SNNS / SNUBHGS01
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, Sentinel node navigation surgery, Dual method, Recurrence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 27 Sep 2011 (estimated)
- 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.
There are few reports on a dual dye and isotope approach using laparoscopy in gastric cancer sentinel node mapping.
The aim of this study was to evaluate the feasibility of laparoscopic limited gastrectomy with sentinel basin(SB) dissection for gastric cancer using simultaneous indocyanine green (ICG) and 99mTc-antimony sulfur colloid (ASC) injections.
Detailed description
Prospective phase II clinical trials for sentinel node navigation surgery(SNNS) in early gastric cancer.
Laparoscopic SNNS:
- ICG and 99mTc-antimony sulfur colloid (ASC) submucosal injection under intraoperative endoscopy
- Sentinel node basin identification and dissection
- Sentinel nodes picking in back table
- Frozen biopsy of sentinel nodes(hematoxylin and eosin staining and immunohistochemistry for cytokeratin)
- If the sentinel node biopsy by frozen section is negative, limited gastrectomy will be performed or if positive, radical D2 gastrectomy will be performed.
Sample size: 100 cases
Study duration: 5 years( 2year enrollment, 3 year follow-up)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic sentinel node navigation surgery | Experimental | Procedure: Laparoscopic sentinel node navigation surgeryLaparoscopic sentinel node navigation surgery |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 20-80
- Informed consent
- No other malignancies
- cT1N0 stage gastric cancers < 4cm
- no allergic history of isotope
Key exclusion criteria (1 listed)
- Patients eligible for endoscopic submucosal dissection(ESD) with absolute indication
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 |
|---|---|---|
| Laparoscopic sentinel node navigation surgeryLaparoscopic SNNS using simultaneous indocyanine green (ICG) and 99mTc-antimony sulfur colloid (ASC) injections | Procedure or surgery | Laparoscopic sentinel node navigation surgery |
Primary outcome
3 Year disease free survival
Time frame: Postoperative 3 year
Recurrence evaluation by eddoscopy, computed tomography and Positron emission tomography if needed.
1 secondary outcome
Sentinel node detection rate, occurrence of complication ,Qualtity of life and remnant stomach function evaluation.
Time frame: postoperative 1, 3, 6, 12 month
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 9 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Hyung-Ho Kim, M.D.Ph.D. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laparoscopic sentinel node navigation surgery in people with Gastric Cancer, run by Seoul National University Bundang Hospital at 1 site 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 5 inclusion and 1 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 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
3 Year disease free survival (time frame: Postoperative 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2017.