Gastric Subepithelial TumorPhase 1EFTR-LANCT02042079
Endoscopic Full Thickness Resection With Laparoscopic Assistance
A Phase 1 study testing EFTR with LA in people with Gastric Subepithelial Tumor, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the feasibility of endoscopic full-thickness resection with laparoscopic assistance. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Subepithelial Tumor
- What is being tested?
- EFTR with LA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2012to Mar 2014
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gastric subepithelial tumor
- Invasion of muscularis propria on Endoscopic ultrasound
- Tumor size 1.5cm-5cm or increasing size during follow-up
Who cannot join
- Bleeding tendency,
- Inappropriate condition for surgery with general anesthesia
- Refuse to be enrolled to study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center
Goyang-si, Gyeonggi-do, 410-769
Chan G Kim, M.D., +82-31-920-1620, glse@chol.com
About this study
Official title: Endoscopic Full Thickness Resection With Laparoscopic Assistance, Single Center Single Arm Study
The purpose of this study is to evaluate the feasibility of endoscopic full-thickness resection with laparoscopic assistance.
Read the detailed description
The laparoscopic resection with a linear stapler for subepithelial tumors (SET) can lead to excessive resection of healthy tissue of the gastric wall resulting in deformity or stenosis. Attaining a positive surgical margin is also possible. Endoscopic full-thickness resection (EFTR) can be used for tumor resection by direct visualization of the tumor from inside the stomach lumen leading to a free surgical margin with little resection of healthy tissue. In order to overcome current endoscopic technical limitations, we will combine the conventional laparoscopic approach with EFTR.
- Conditions
- Gastric Subepithelial Tumor
- Being tested
- EFTR with LA
- Keywords
- Endoscopic full-thickness resection, gastric subepithelial tumor, hybrid-NOTES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EFTR with LAProcedure or surgery
(Endoscopic full-thickness resection with laparoscopic assistance)
| Study group | Role | What they receive |
|---|---|---|
| EFTR with LA | Experimental | (Endoscopic full-thickness resection with laparoscopic assistance) Receives: Procedure: EFTR with LA |
What is being measured
The primary outcome is the main question the study is designed to answer.
En-bloc resection and successful closure
successful En-bloc resection of subepithelial tumor and successful closure of resection site by Endoscopic full-thickness resection with laparoscopic assistance.
Measured: 3 months after surgery
Secondary outcomes (1)
number of troche
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startJul 2012
- Primary completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Subepithelial TumorStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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 G Kim, M.D., Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042079
- Sponsor's protocol ID
- NCCCTS-604
- Acronym
- EFTR-LA
- Status last verified
- Jan 2014
- First submitted
- 19 Jan 2014
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Full Thickness Resection With Laparoscopic Assistance, Single Center Single Arm Study
- ClinicalTrials.gov ID
- NCT02042079
- Acronym / sponsor ID
- EFTR-LA / NCCCTS-604
- Conditions
- Gastric Subepithelial Tumor
- Keywords
- Endoscopic full-thickness resection, gastric subepithelial tumor, hybrid-NOTES
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Jul 2012
- Primary completion
- Mar 2014 (estimated)
- First posted
- 22 Jan 2014 (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.
The purpose of this study is to evaluate the feasibility of endoscopic full-thickness resection with laparoscopic assistance.
Detailed description
The laparoscopic resection with a linear stapler for subepithelial tumors (SET) can lead to excessive resection of healthy tissue of the gastric wall resulting in deformity or stenosis. Attaining a positive surgical margin is also possible. Endoscopic full-thickness resection (EFTR) can be used for tumor resection by direct visualization of the tumor from inside the stomach lumen leading to a free surgical margin with little resection of healthy tissue. In order to overcome current endoscopic technical limitations, we will combine the conventional laparoscopic approach with EFTR.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EFTR with LA | Experimental | Procedure: EFTR with LA(Endoscopic full-thickness resection with laparoscopic assistance) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Gastric subepithelial tumor
- Invasion of muscularis propria on Endoscopic ultrasound
- Tumor size 1.5cm-5cm or increasing size during follow-up
Key exclusion criteria (3 listed)
- Bleeding tendency,
- Inappropriate condition for surgery with general anesthesia
- Refuse to be enrolled to study
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 |
|---|---|---|
| EFTR with LA(Endoscopic full-thickness resection with laparoscopic assistance) | Procedure or surgery | EFTR with LA |
Primary outcome
En-bloc resection and successful closure
Time frame: 3 months after surgery
successful En-bloc resection of subepithelial tumor and successful closure of resection site by Endoscopic full-thickness resection with laparoscopic assistance.
1 secondary outcome
number of troche
Time frame: during surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
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 G Kim, M.D. principal investigator
National Cancer Center, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EFTR with LA in people with Gastric Subepithelial Tumor, 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 3 inclusion and 3 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 22 Jan 2014. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 G Kim, M.D. (+82-31-920-1620, glse@chol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
En-bloc resection and successful closure (time frame: 3 months after surgery). 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 22 Jan 2014.