Efficacy and Safety Study of Endoscopic Submucosal Dissection for Early Gastric Cancer
NCT ID: NCT01132469
Last Updated: 2010-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1158 participants
INTERVENTIONAL
2010-05-31
2017-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Endoscopic Submucosal Dissection
Single-arm for ESD procedure and retrospective surgical procedure(Laparoscopy, Open surgery)data collection
Endoscopic Submucosal Dissection
5-years follow-up after Endoscopic Submucosal Dissection
Interventions
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Endoscopic Submucosal Dissection
5-years follow-up after Endoscopic Submucosal Dissection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
Exclusion Criteria
* 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
2. Surgery Group(Retrospective data collection)
20 Years
ALL
No
Sponsors
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National Evidence-Based Healthcare Collaborating Agency
OTHER_GOV
Responsible Party
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National Evidence-based Healthcare Collaborating Agency
Principal Investigators
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Sang-Yong Seol, M.D.
Role: PRINCIPAL_INVESTIGATOR
Inje University College of Medicine
Locations
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Inje University Busan Baik Hospital and 10 other institutes
Busan, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Sang-Yong Seol, M.D.
Role: primary
Other Identifiers
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NA09-003
Identifier Type: -
Identifier Source: org_study_id