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Trial Title:
Efficacy and Safety Study of Endoscopic Submucosal Dissection for Early Gastric Cancer
NCT ID:
NCT01132469
Condition:
Endoscopic Submucosal Dissection
Early Gastric Cancer
Multi-center, Single-arm Clinical Trial
Historical Control Group
Quality of Life and Cost Analysis
Conditions: Official terms:
Stomach Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Endoscopic Submucosal Dissection
Description:
5-years follow-up after Endoscopic Submucosal Dissection
Arm group label:
Endoscopic Submucosal Dissection
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.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Inje University Busan Baik Hospital and 10 other institutes
Address:
City:
Busan
Zip:
614-735
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Sang-Yong Seol, M.D.
Phone:
82-51-890-6158
Email:
seolsymd@hanmail.net
Investigator:
Last name:
Sang-Yong Seol, M.D.
Email:
Principal Investigator
Start date:
May 2010
Completion date:
June 2017
Lead sponsor:
Agency:
National Evidence-Based Healthcare Collaborating Agency
Agency class:
Other
Source:
National Evidence-Based Healthcare Collaborating Agency
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01132469
