Long-term Follow-up After Endoscopic Submucosal Dissection for Early Gastric Cancer
20 Years
N/A
Both
Endoscopic Submucosal Dissection, Early Gastric Cancer, Multi-center, Single-arm Clinical Trial, Historical Control Group, Quality of Life and Cost Analysis
Trial Information
Long-term Follow-up After Endoscopic Submucosal Dissection for Early Gastric Cancer
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.
1. ESD GROUP
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
2. Surgery Group(Retrospective data collection)
Inclusion Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
5-year disease(gastric cancer)-free survival rate after ESD procedure
Outcome Time Frame:
5 years after ESD
Safety Issue:
No
Principal Investigator
Sang-Yong Seol, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Inje University College of Medicine
Authority:
South Korea: Institutional Review Board
Study ID:
NA09-003
NCT ID:
NCT01132469
Start Date:
May 2010
Completion Date:
June 2017
Related Keywords:
- Endoscopic Submucosal Dissection
- Early Gastric Cancer
- Multi-center, Single-arm Clinical Trial
- Historical Control Group
- Quality of Life and Cost Analysis
- Stomach Neoplasms
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