Early Gastric CancerNCT02216110
Endoscopic Submucosal Dissection Versus Gastrectomy
An observational study of Early Gastric Cancer, run by Soonchunhyang University Hospital at 1 site in South Korea.
Trial summary
Gastrectomy is curative treatment for early gastric cancer (EGC). Recently, endoscopic submucosal dissection (ESD) has been accepted as standard treatment in selected patients with negligible risk of lymph node metastasis. 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?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2003to Mar 2015
- Phase
- Observational
- 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
Study population: All patients with early gastric cancer were treated by surgery or ESD at a single, tertiary-care, academic medical center.
Who may be able to join
- differentiated type mucosal cancer without ulceration, regardless of tumor size
- differentiated type mucosal cancer with ulceration ≤ 3 cm in diameter
- superficial (SM1 < 500 μm) submucosal cancer ≤ 3 cm in diameter
- undifferentiated type mucosal cancer without ulceration ≤ 2 cm in diameter
Who cannot join
- early gastric cancer in a remnant stomach
- gastrectomy due to metachronous lesions during follow-up period
- post-ESD additional surgery due to high risk of lymph node metastasis or the possibility of residual tumor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Outcomes of Endoscopic Submucosal Dissection Versus Gastrectomy for Early Gastric Cancer
Gastrectomy is curative treatment for early gastric cancer (EGC). Recently, endoscopic submucosal dissection (ESD) has been accepted as standard treatment in selected patients with negligible risk of lymph node metastasis. However, there are limited data regarding the long-term outcomes of ESD in comparison with surgery. This protocol aims to compare overall survival rate, tumor recurrence, development of metachronous cancers after ESD and surgery.
Read the detailed description
The prevalence of gastric cancer is high in Asia, especially in Korea and Japan. In Korea, the detection rate of EGC has increased with mass screening for the prevention of gastric cancer-related death. EGC is defined as mucosal or submucosal cancer, regardless of regional lymph node metastasis. The presence of lymph node metastasis has been reported to range from 2% to 18%. For this reason, radical gastrectomy with lymph node dissection was considered as the only curative treatment. In EGC patients, surgical outcome demonstrated excellent 5-year survival rate above 90%.
In 2000, EGC subgroups with negligible risk of lymph node metastasis were proposed on the basis of large scale retrospective data. Thereafter, the result was adopted as expanded criteria for endoscopic resection of EGC. ESD is useful technique to dissect the tumor along the submucosal layer using various endoscopic knives. Compared to endoscopic mucosal resection (EMR), ESD achieved a higher complete resection rate and a lower local tumor recurrence rate.
Although curative resection is pathologically achieved by ESD, post-resection surveillance is needed to confirm the presence of nodal metastasis. Recently, several studies reported that 5-year overall and disease-specific survival rate were highly favorable in EGC patients who underwent curative ESD. However, there is no comparative study about long-term outcomes after ESD and gastrectomy. Therefore, this protocol aims to evaluate overall survival rate, tumor recurrence, development of metachronous cancers between ESD and surgery groups.
- Conditions
- Early Gastric Cancer
- Being tested
- Surgery
- Keywords
- Endoscopic submucosal dissection, Gastrectomy, Survival, Outcome
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Surgery for early gastric cancer includes distal gastrectomy, total gastrectomy, proximal gastrectomy, and wedge resection
| Study group | Role | What they receive |
|---|---|---|
| Surgery group | Patients who underwent surgery as treatment of early gastric cancer Receives: Procedure: Surgery | |
| ESD group | Patients who underwent endoscopic submucosal dissection (ESD) as treatment of early gastric cancer, instead of surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's death
Measured: up to 5 years
Secondary outcomes (2)
Tumor recurrence
Measured: up to 5 years
Development of metachronous cancers
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startMay 2003
- Primary completionDec 2014
- Study completionMar 2015
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun-Hyung Cho, Soonchunhyang University Hospital
- Investigators
- Jun-Hyung Cho, M.D., Principal investigator, Soonchunhyang University Hospital, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216110
- Sponsor's protocol ID
- SCHDDC-2014-01
- Status last verified
- May 2015
- First submitted
- 9 Aug 2014
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes of Endoscopic Submucosal Dissection Versus Gastrectomy for Early Gastric Cancer
- ClinicalTrials.gov ID
- NCT02216110
- Acronym / sponsor ID
- SCHDDC-2014-01
- Conditions
- Early Gastric Cancer
- Keywords
- Endoscopic submucosal dissection, Gastrectomy, Survival, Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- May 2003
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 13 Aug 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.
Gastrectomy is curative treatment for early gastric cancer (EGC). Recently, endoscopic submucosal dissection (ESD) has been accepted as standard treatment in selected patients with negligible risk of lymph node metastasis. However, there are limited data regarding the long-term outcomes of ESD in comparison with surgery. This protocol aims to compare overall survival rate, tumor recurrence, development of metachronous cancers after ESD and surgery.
Detailed description
The prevalence of gastric cancer is high in Asia, especially in Korea and Japan. In Korea, the detection rate of EGC has increased with mass screening for the prevention of gastric cancer-related death. EGC is defined as mucosal or submucosal cancer, regardless of regional lymph node metastasis. The presence of lymph node metastasis has been reported to range from 2% to 18%. For this reason, radical gastrectomy with lymph node dissection was considered as the only curative treatment. In EGC patients, surgical outcome demonstrated excellent 5-year survival rate above 90%.
In 2000, EGC subgroups with negligible risk of lymph node metastasis were proposed on the basis of large scale retrospective data. Thereafter, the result was adopted as expanded criteria for endoscopic resection of EGC. ESD is useful technique to dissect the tumor along the submucosal layer using various endoscopic knives. Compared to endoscopic mucosal resection (EMR), ESD achieved a higher complete resection rate and a lower local tumor recurrence rate.
Although curative resection is pathologically achieved by ESD, post-resection surveillance is needed to confirm the presence of nodal metastasis. Recently, several studies reported that 5-year overall and disease-specific survival rate were highly favorable in EGC patients who underwent curative ESD. However, there is no comparative study about long-term outcomes after ESD and gastrectomy. Therefore, this protocol aims to evaluate overall survival rate, tumor recurrence, development of metachronous cancers between ESD and surgery groups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery group | – | Procedure: SurgeryPatients who underwent surgery as treatment of early gastric cancer |
| ESD group | – | –Patients who underwent endoscopic submucosal dissection (ESD) as treatment of early gastric cancer, instead of surgery |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with early gastric cancer were treated by surgery or ESD at a single, tertiary-care, academic medical center.
Key inclusion criteria (4 listed)
- differentiated type mucosal cancer without ulceration, regardless of tumor size
- differentiated type mucosal cancer with ulceration ≤ 3 cm in diameter
- superficial (SM1 < 500 μm) submucosal cancer ≤ 3 cm in diameter
- undifferentiated type mucosal cancer without ulceration ≤ 2 cm in diameter
Key exclusion criteria (3 listed)
- early gastric cancer in a remnant stomach
- gastrectomy due to metachronous lesions during follow-up period
- post-ESD additional surgery due to high risk of lymph node metastasis or the possibility of residual tumor
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 |
|---|---|---|
| SurgerySurgery for early gastric cancer includes distal gastrectomy, total gastrectomy, proximal gastrectomy, and wedge resection | Procedure or surgery | Surgery group |
Primary outcome
Patient's death
Time frame: up to 5 years
2 secondary outcomes
Tumor recurrence
Time frame: up to 5 years
Development of metachronous cancers
Time frame: up to 5 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 20 May 2015.
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
RecruitingObservational study
Breath Research Narrow Validation for Gastrointestinal Cancer Detection
Oesophageal Squamous Cell Carcinoma, Oesophageal Adenocarcinoma
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
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.
Jun-Hyung Cho, M.D. principal investigator
Soonchunhyang University Hospital, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Gastric Cancer, run by Soonchunhyang University 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 4 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: finished, as of the sponsor's last update on 20 May 2015. 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?
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?
Patient's death (time frame: up to 5 years). 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 20 May 2015.