Early Gastric CancerNCT01544413
Quality Control Study of Laparoscopic Sentinel Node Biopsy in Early Gastric Cancer
A study testing Laparoscopic sentinel lymph node biopsy in people with Early Gastric Cancer, run by National Cancer Center, Korea at 15 sites in South Korea.
Trial summary
Laparoscopic sentinel lymph node biopsy and stomach preserving surgery in ealry gastric cancer is less invasive method which can increase quality of life. Multicenter phase III trial is requred to validate this method. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Early Gastric Cancer
- What is being tested?
- Laparoscopic sentinel lymph node biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 15 sitesSouth Korea
- Study dates
- Feb 2012to Sep 2014
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- gastric adenocarcinoma in preoperative endoscopic biopsy
- clinical stage T1-2N0
- long diameter of tumor <4cm
- distance between tumor and pylorus or cardia >2cm
- age: 20-80
- ECOG: 1 or 0
- patients will undergo laparoscopic gastrectomy
Who cannot join
- definite criteria of endoscopic submucosal dissection (size<2cm, differentiated type, no ulcer)
- no indication for surgery for cardiovascular, pulmonary disease
- pregancy
- drug allergy or previous abdominal surgery, radiotherpy
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
South Korea15 sites
Hallym University Sacred Heart Hospital
Anyang
Soonchunhyang University Bucheon Hospital
Bucheon-si
Dong-A University College of Medicine
Busan
Dongnam Institute of Radiological and Medical Science
Busan
Keimyung University School of Medicine
Daegu
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, 410-769
Chonnam National University Hwasun Hospital
Hwasun, Chonnam
Gyeongsang National University
Jinju, Gyeongsangnam-do
Korea University Guro Hospital
Seoul, Seoul
Yonsei Univeristy College of Medicine
Seoul, Seoul
Korea University College of Medicine
Seoul
Kyung Hee University Gangdong Hospital
Seoul
Seoul St. Mary's Hospital
Seoul
Yeouido St. Mary's Hospital
Seoul
Ajou University School of Medicine
Suwon, Gyeonggi-do
About this study
Official title: Quality Control Study for Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy and Stomach Preserving Surgery in Early Gastric Cancer
Laparoscopic sentinel lymph node biopsy and stomach preserving surgery in ealry gastric cancer is less invasive method which can increase quality of life. Multicenter phase III trial is requred to validate this method. In this study all items which are necessary for laparoscopic sentinel lymph node biopsy are identified according to checklist and evaluated the performance completement.
- Conditions
- Early Gastric Cancer
- Being tested
- Laparoscopic sentinel lymph node biopsy
- Keywords
- laparoscopic sentinel lymph node biopsy, quality control study, early gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic sentinel lymph node biopsyProcedure or surgery
Also called Tc 99m HSA (Frosstimage), indocyanine green (IC-GREEN™ (Akorn)), laparoscopic probe (neoprobe® GDS gamma detection system)
During the operation, endoscopic marking was perfomed using Tc 99m HSA and indocyanine green around tumor. Then we identify the sentinel lymph node with laparoscopic probe. Laparoscopic sentinel lymph nodes were dissedted and evaluated them at the backtable in the operating room.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic sentinel lymph node biopsy | Experimental | This is a single armed study. After endoscopic marking using Tc99m HSA and indocyanine green fluid, Laparoscopic sentinel lymph node biopsy was performed and evalute at backtable. Receives: Procedure: Laparoscopic sentinel lymph node biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completement of performance of laparoscopic sentinel lymph node biopsy
Investigators will make out a checklist after operation for evaluating the completement of performance of laparoscopic sentinel lymph node biopsy. The checklist will be made out within 24 hours.
Measured: within 24 hours after operation
Secondary outcomes (1)
Detection rate of laparoscopic sentinel lymph node, learning curve
Detection rate of laparoscopic sentinel lymph node is evaluated within 7 days after operation by pathological examination. Learning curve can be drawn after all cases' data are collected, so it takes upto 2 years.
Measured: upto 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Keun Won Ryu, National Cancer Center, Korea
- Investigators
- Keun Won Ryu, Doctor, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544413
- Sponsor's protocol ID
- SENORITA-2012
- Status last verified
- Dec 2014
- First submitted
- 16 Feb 2012
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Control Study for Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy and Stomach Preserving Surgery in Early Gastric Cancer
- ClinicalTrials.gov ID
- NCT01544413
- Acronym / sponsor ID
- SENORITA-2012
- Conditions
- Early Gastric Cancer
- Keywords
- laparoscopic sentinel lymph node biopsy, quality control study, early gastric cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Feb 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 5 Mar 2012 (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.
Laparoscopic sentinel lymph node biopsy and stomach preserving surgery in ealry gastric cancer is less invasive method which can increase quality of life. Multicenter phase III trial is requred to validate this method. In this study all items which are necessary for laparoscopic sentinel lymph node biopsy are identified according to checklist and evaluated the performance completement.
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 lymph node biopsy | Experimental | Procedure: Laparoscopic sentinel lymph node biopsyThis is a single armed study. After endoscopic marking using Tc99m HSA and indocyanine green fluid, Laparoscopic sentinel lymph node biopsy was performed and evalute at backtable. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- gastric adenocarcinoma in preoperative endoscopic biopsy
- clinical stage T1-2N0
- long diameter of tumor <4cm
- distance between tumor and pylorus or cardia >2cm
- age: 20-80
Key exclusion criteria (4 listed)
- definite criteria of endoscopic submucosal dissection (size<2cm, differentiated type, no ulcer)
- no indication for surgery for cardiovascular, pulmonary disease
- pregancy
- drug allergy or previous abdominal surgery, radiotherpy
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 lymph node biopsyAlso: Tc 99m HSA (Frosstimage), indocyanine green (IC-GREEN™ (Akorn)), laparoscopic probe (neoprobe® GDS gamma detection system)During the operation, endoscopic marking was perfomed using Tc 99m HSA and indocyanine green around tumor. Then we identify the sentinel lymph node with laparoscopic probe. Laparoscopic sentinel lymph nodes were dissedted and evaluated them at the backtable in the operating room. | Procedure or surgery | Laparoscopic sentinel lymph node biopsy |
Primary outcome
Completement of performance of laparoscopic sentinel lymph node biopsy
Time frame: within 24 hours after operation
Investigators will make out a checklist after operation for evaluating the completement of performance of laparoscopic sentinel lymph node biopsy. The checklist will be made out within 24 hours.
1 secondary outcome
Detection rate of laparoscopic sentinel lymph node, learning curve
Time frame: upto 2 years
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 16 Dec 2014.
Related trials for Early Gastric Cancer
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Active, not recruitingObservational study
Early Recovery After Surgery Protocol in Improving Quality of Life in Participants With Stage 0-IIIC Gastric Cancer Undergoing Surgery
Clinical Stage 0 Gastric Cancer AJCC v8, Clinical Stage I Gastric Cancer AJCC v8
RecruitingObservational study
Breath Research Narrow Validation for Gastrointestinal Cancer Detection
Oesophageal Squamous Cell Carcinoma, Oesophageal Adenocarcinoma
RecruitingObservational study
The EpiGASTRIC/EDGAR Project: New Strategies for the Early Detection and Prevention of Gastric Cancer
Gastric Neoplasms, Gastric 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.
Keun Won Ryu, Doctor principal investigator
National Cancer Center, Korea
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic sentinel lymph node biopsy in people with Early Gastric Cancer, run by National Cancer Center, Korea at 15 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 7 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 16 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Completement of performance of laparoscopic sentinel lymph node biopsy (time frame: within 24 hours after operation). 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 16 Dec 2014.