Endoscopic Submucosal DissectionESDNCT01132469
Efficacy and Safety Study of Endoscopic Submucosal Dissection for Early Gastric Cancer
A study testing Endoscopic Submucosal Dissection in people with Endoscopic Submucosal Dissection and Early Gastric Cancer, run by National Evidence-Based Healthcare Collaborating Agency at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the safety and clinical effectiveness of ESD(Endoscopic Submucosal Dissection) for early gastric cancer analyzing short-term and long-term results of endoscopic treatment. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Endoscopic Submucosal Dissection, Early Gastric Cancer, Multi-center, Single-arm Clinical Trial
- What is being tested?
- Endoscopic Submucosal Dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,158 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to Jun 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Korean people aged >=20 years
- Endoscopic Grossly the lesion diameter ≤ 3cm
- Endoscopic biopsy results: Well-differentiated and moderately differentiated adenocarcinoma
- No ulcers in lesions
- Endoscopic biopsy results: In case of gastric cancer, no metastasis in CT test performed before ESD procedure
- Subject with gastric laparoscopy or open-surgery for treatment early gastric cancer during 2002.1.1 ~2004. 12. 31
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- Korean people aged >=20 years
- Early gastric cancer confirmed by pathology during gastric surgery; Gastric cancer confirmed to the mucosal or submucosal regardless of lymph node metastasis
- No history of malignant disease in other organs
- No history of stomach surgery due to peptic ulceration etc.
Who cannot join
- Subject with history of malignant disease in other organs
- Subject with history of stomach surgery due to peptic ulceration etc.
- As the cases of an absolute contraindication of general anesthesia; Subject with chronic liver disease over Child score B, Subject with chronic Renal Disease requiring hemodialysis or peritoneal dialysis, Subject with heart failure more than Ⅲ score according to New York Heart Association Classification, Subject with severe systemic diseases such as respiratory disease
- Subject with Bleeding tendency
- Pregnant woman or woman with possibility of pregnancy
- Subject who cann't be obtained informed consent
- Subject who is unable to follow up for any other reason
- Surgery Group(Retrospective data collection)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Inje University Busan Baik Hospital and 10 other institutes
Busan, 614-735
Sang-Yong Seol, M.D., 82-51-890-6158, seolsymd@hanmail.net
Sang-Yong Seol, M.D.
About this study
Official title: Long-term Follow-up After Endoscopic Submucosal Dissection for Early Gastric Cancer
The purpose of this study is to evaluate the safety and clinical effectiveness of ESD(Endoscopic Submucosal Dissection) for early gastric cancer analyzing short-term and long-term results of endoscopic treatment.
Read the detailed description
Traditionally open-gastrectomy is the standard treatment for gastric cancer without distant metastasis, but high mortality and morbidity, the intense weight loss, food intake difficulties after surgery are fraught, including problems with the drawback of significantly degrading the quality of life. Therefore, a lot of effort to seek the more simple treatment than open gastrectomy has been made, recently the endoscopic treatment for early gastric cancer is the most widely used treatment.
This single-arm, multi-center study enroll early gastric cancer patients after ESD compared with the retrospective control(surgical treatment) group considering the unreality of the randomized clinical trials. In addition, the quality of life assessment by the EORTC C30/STO22 tools before and after ESD procedure in enrolled patients will be performed and the direct cost analysis also will be conducted.
- Conditions
- Endoscopic Submucosal Dissection, Early Gastric Cancer, Multi-center, Single-arm Clinical Trial, Historical Control Group, Quality of Life and Cost Analysis
- Being tested
- Endoscopic Submucosal Dissection
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Submucosal DissectionProcedure or surgery
5-years follow-up after Endoscopic Submucosal Dissection
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Submucosal Dissection | Experimental | Single-arm for ESD procedure and retrospective surgical procedure(Laparoscopy, Open surgery)data collection Receives: Procedure: Endoscopic Submucosal Dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year disease(gastric cancer)-free survival rate after ESD procedure
Measured: 5 years after ESD
Secondary outcomes (5)
Short-term result(Histological complete resection,complication)
Measured: within the first 7 days after ESD
The incidence of reoccurrence and Ectopic foci
Measured: within the first 7 days and 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD
The quality of life after ESD
Measured: before and 7 days, 3months, 6months after ESD
The costs of ESD
Measured: From the admission to discharge
The safety of ESD procedure
Measured: within the 7 days, 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Submucosal DissectionStudies 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
- 1,158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Evidence-Based Healthcare Collaborating Agency
- Sponsor type
- Other government
- Investigators
- Sang-Yong Seol, M.D., Principal investigator, Inje University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132469
- Sponsor's protocol ID
- NA09-003
- Acronym
- ESD
- Status last verified
- May 2010
- First submitted
- 24 May 2010
- Last updated
- 28 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up After Endoscopic Submucosal Dissection for Early Gastric Cancer
- ClinicalTrials.gov ID
- NCT01132469
- Acronym / sponsor ID
- ESD / NA09-003
- Conditions
- Endoscopic Submucosal Dissection, Early Gastric Cancer, Multi-center, Single-arm Clinical Trial, Historical Control Group, Quality of Life and Cost Analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,158 participants (estimated)
- Lead sponsor
- National Evidence-Based Healthcare Collaborating AgencyOther government
- Study start
- May 2010
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 28 May 2010 (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 safety and clinical effectiveness of ESD(Endoscopic Submucosal Dissection) for early gastric cancer analyzing short-term and long-term results of endoscopic treatment.
Detailed description
Traditionally open-gastrectomy is the standard treatment for gastric cancer without distant metastasis, but high mortality and morbidity, the intense weight loss, food intake difficulties after surgery are fraught, including problems with the drawback of significantly degrading the quality of life. Therefore, a lot of effort to seek the more simple treatment than open gastrectomy has been made, recently the endoscopic treatment for early gastric cancer is the most widely used treatment.
This single-arm, multi-center study enroll early gastric cancer patients after ESD compared with the retrospective control(surgical treatment) group considering the unreality of the randomized clinical trials. In addition, the quality of life assessment by the EORTC C30/STO22 tools before and after ESD procedure in enrolled patients will be performed and the direct cost analysis also will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Submucosal Dissection | Experimental | Procedure: Endoscopic Submucosal DissectionSingle-arm for ESD procedure and retrospective surgical procedure(Laparoscopy, Open surgery)data collection |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject with gastric laparoscopy or open-surgery for treatment early gastric cancer during 2002.1.1 ~2004. 12. 31
- Korean people aged >=20 years
- Early gastric cancer confirmed by pathology during gastric surgery; Gastric cancer confirmed to the mucosal or submucosal regardless of lymph node metastasis
- No history of malignant disease in other organs
- No history of stomach surgery due to peptic ulceration etc.
Key exclusion criteria (8 listed)
- Surgery Group(Retrospective data collection)
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 |
|---|---|---|
| Endoscopic Submucosal Dissection5-years follow-up after Endoscopic Submucosal Dissection | Procedure or surgery | Endoscopic Submucosal Dissection |
Primary outcome
5-year disease(gastric cancer)-free survival rate after ESD procedure
Time frame: 5 years after ESD
5 secondary outcomes
Short-term result(Histological complete resection,complication)
Time frame: within the first 7 days after ESD
The incidence of reoccurrence and Ectopic foci
Time frame: within the first 7 days and 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD
The quality of life after ESD
Time frame: before and 7 days, 3months, 6months after ESD
The costs of ESD
Time frame: From the admission to discharge
The safety of ESD procedure
Time frame: within the 7 days, 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2010.
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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.
Sang-Yong Seol, M.D. principal investigator
Inje University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Submucosal Dissection in people with Endoscopic Submucosal Dissection and Early Gastric Cancer, run by National Evidence-Based Healthcare Collaborating Agency 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 10 inclusion and 8 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 28 May 2010. 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 Eunhee Shin, Ph.D. (82-2-2174-2740, hshin@neca.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year disease(gastric cancer)-free survival rate after ESD procedure (time frame: 5 years after ESD). 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 28 May 2010.