Early Gastric CancerNCT03216174
Pilot Study of Non-exposure Simple Suturing EFTR With Sentinel Lymph Node Navigation for EGC (Senorita3-pilot)
A study testing NESS-EFTR in people with Early Gastric Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
Laparoscopic sentinel lymph node dissection and stomach preserving surgery in early gastric cancer is less invasive method which can increase quality of life. Current stomach preserving surgery after sentinel lymph node dissection produce transmural communication and expose the tumor to the peritoneum during… 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?
- NESS-EFTR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Jul 2017to 30 Jun 2018
- 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
- 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 in differentiated type, less than 2cm in undifferentiated type
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Non-exposure Simple Suturing EFTR (NESS-EFTR) With Sentinel Lymph Node Navigation for Early Gastric Cancer (Senorita3-pilot)
Laparoscopic sentinel lymph node dissection and stomach preserving surgery in early gastric cancer is less invasive method which can increase quality of life. Current stomach preserving surgery after sentinel lymph node dissection produce transmural communication and expose the tumor to the peritoneum during operation. An endoscopic full-thickness resection method with a simple suturing technique that does not expose the gastric mucosa to the peritoneum (non-exposure simple suturing, NESS) was recently developed.
This is the pilot study to prove the feasibility of NESS-EFTR with sentinel node navigation in early gastric cancer patients.
- Conditions
- Early Gastric Cancer
- Being tested
- NESS-EFTR
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NESS-EFTRProcedure or surgery
NESS-EFTR includes steps of laparoscopic seromuscular suturing, EFTR of the inverted stomach wall, and endoscopic mucosal suturing with endoloops and clips.
| Study group | Role | What they receive |
|---|---|---|
| NESS-EFTR | Experimental | This arm will be received non-exposure simple suturing endoscopic full-thickness resection after sentinel lymph node navigation Receives: Procedure: NESS-EFTR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete resection
single piece resection with clear resection margin
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start11 Jul 2017 (estimated)
- Primary completion31 Dec 2017 (estimated)
- Study completion30 Jun 2018 (estimated)
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 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Chan Gyoo Kim, National Cancer Center, Korea
- Investigators
- Chan Gyoo Kim, M.D., Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216174
- Sponsor's protocol ID
- NCC2017-0088
- Status last verified
- Jul 2017
- First submitted
- 10 Jul 2017
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Eom BW, Kim CG, Kook MC, Yoon HM, Ryu KW, Kim YW, Rho JY, Kim YI, Lee JY, Choi IJ. Non-exposure Simple Suturing Endoscopic Full-thickness Resection with Sentinel Basin Dissection in Patients with Early Gastric Cancer: the SENORITA 3 Pilot Study. J Gastric Cancer. 2020 Sep;20(3):245-255. doi: 10.5230/jgc.2020.20.e22. Epub 2020 Jul 6.
PubMed 33024581
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Non-exposure Simple Suturing EFTR (NESS-EFTR) With Sentinel Lymph Node Navigation for Early Gastric Cancer (Senorita3-pilot)
- ClinicalTrials.gov ID
- NCT03216174
- Acronym / sponsor ID
- NCC2017-0088
- Conditions
- Early Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 11 Jul 2017 (estimated)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 13 Jul 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.
Laparoscopic sentinel lymph node dissection and stomach preserving surgery in early gastric cancer is less invasive method which can increase quality of life. Current stomach preserving surgery after sentinel lymph node dissection produce transmural communication and expose the tumor to the peritoneum during operation. An endoscopic full-thickness resection method with a simple suturing technique that does not expose the gastric mucosa to the peritoneum (non-exposure simple suturing, NESS) was recently developed.
This is the pilot study to prove the feasibility of NESS-EFTR with sentinel node navigation in early gastric cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NESS-EFTR | Experimental | Procedure: NESS-EFTRThis arm will be received non-exposure simple suturing endoscopic full-thickness resection after sentinel lymph node navigation |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 in differentiated type, less than 2cm in undifferentiated type
- location: 2cm far from the pylorus or cardia
- aged 20 to 80
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| NESS-EFTRNESS-EFTR includes steps of laparoscopic seromuscular suturing, EFTR of the inverted stomach wall, and endoscopic mucosal suturing with endoloops and clips. | Procedure or surgery | NESS-EFTR |
Primary outcome
Complete resection
Time frame: 3 months
single piece resection with clear resection margin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- Derived from this study: PubMed 33024581Eom BW, Kim CG, Kook MC, Yoon HM, Ryu KW, Kim YW, Rho JY, Kim YI, Lee JY, Choi IJ. Non-exposure Simple Suturing Endoscopic Full-thickness Resection with Sentinel Basin Dissection in Patients with Early Gastric Cancer: the SENORITA 3 Pilot Study. J Gastric Cancer. 2020 Sep;20(3):245-255. doi: 10.5230/jgc.2020.20.e22. Epub 2020 Jul 6.
- Individual participant dataSharing planned: Undecided
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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.
Chan Gyoo Kim, M.D. principal investigator
National Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NESS-EFTR in people with Early Gastric Cancer, run by National Cancer Center, Korea 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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Jul 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chan Gyoo Kim, M.D. (+319201620, glse@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete resection (time frame: 3 months). 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 NCT03216174, 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 13 Jul 2017.