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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
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Busan、大韓民国、614-735
- 募集
- Inje University Busan Baik Hospital and 10 other institutes
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コンタクト：
- Sang-Yong Seol, M.D.
- 電話番号：82-51-890-6158
- メール：seolsymd@hanmail.net
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主任研究者：
- Sang-Yong Seol, M.D.
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：内視鏡的粘膜下層解剖
ESD処置およびレトロスペクティブ外科処置（腹腔鏡検査、開腹手術）データ収集用のシングルアーム
|
5-years follow-up after Endoscopic Submucosal Dissection
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
5-year disease(gastric cancer)-free survival rate after ESD procedure
時間枠：5 years after ESD
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5 years after ESD
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Short-term result(Histological complete resection,complication)
時間枠：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
時間枠：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
|
|
The quality of life after ESD
時間枠：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
時間枠：From the admission to discharge
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From the admission to discharge
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The safety of ESD procedure
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Sang-Yong Seol, M.D.、Inje University College of Medicine
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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