Efficacy and Safety Study of Endoscopic Submucosal Dissection for Early Gastric Cancer (ESD)
Long-term Follow-up After Endoscopic Submucosal Dissection for Early Gastric Cancer
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Busan, 대한민국, 614-735
- 모병
- Inje University Busan Baik Hospital and 10 other institutes
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연락하다:
- Sang-Yong Seol, M.D.
- 전화번호: 82-51-890-6158
- 이메일: seolsymd@hanmail.net
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수석 연구원:
- Sang-Yong Seol, M.D.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 내시경 점막하 절개
ESD 시술 및 후향적 수술(복강경, 개복 수술) 데이터 수집을 위한 단일 팔
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5-years follow-up after Endoscopic Submucosal Dissection
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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5-year disease(gastric cancer)-free survival rate after ESD procedure
기간: 5 years after ESD
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5 years after ESD
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Short-term result(Histological complete resection,complication)
기간: within the first 7 days after ESD
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within the first 7 days after ESD
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The incidence of reoccurrence and Ectopic foci
기간: within the first 7 days and 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD
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within the first 7 days and 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD
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The quality of life after ESD
기간: before and 7 days, 3months, 6months after ESD
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before and 7 days, 3months, 6months after ESD
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The costs of ESD
기간: From the admission to discharge
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From the admission to discharge
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The safety of ESD procedure
기간: within the 7 days, 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD
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within the 7 days, 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sang-Yong Seol, M.D., Inje University College of Medicine
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .