ESI With EUS to Differentiate T3 and T4 ESCC (ESI)
Extraesophageal Saline Injection Combined With EUS to Differentiate Between T3 and T4 Stage Esophageal Squamous Cell Carcinoma - A PhaseⅠTrial
調査の概要
詳細な説明
Esophageal cancer (EC) is one of the most common malignant tumors in the world, and China has the highest incidence of esophageal squamous cell carcinoma (ESCC).According to the TNM staging system of the Union for International Cancer Control (UICC) (7th Edition, 2012), EC invades the esophageal adventitia at the T3 stage; invades the pleura, pericardium and diaphragm at the T4a stage; and involves adjacent vital organs (mainly the thoracic aorta, aortic arch, trachea, tracheal bifurcation, and spine) at the T4b stage.It is considered that T3- and T4a-stage tumors can be surgically resected, while tumors at the T4b stage are not suitable for surgical resection.Therefore, it is important for physicians and patients to know whether the tumor has metastasized to adjacent organs before considering resection. The preoperative stage is unclear in many cases of progressive disease and the involvement of vital organs is only discovered by exploratory thoracotomy, because of which the resection may need to be terminated prematurely, leading to unnecessary injuries.Therefore, accurate preoperative staging of EC, especially during the later stages, is important for deciding the appropriate therapeutic option and evaluation of the prognosis.
The imaging methods used for preoperative staging of EC include endoscopic ultrasonography (EUS). However, EUS has poor accuracy in advanced ESCC, especially in T3 and T4 stage ESCC. Therefore, it is necessary to improve the preoperative accuracy of EUS for advanced EC.
Since extraesophageal space contains loose connective tissue and saline can permeate into extraesophageal space and separate esophagus from adjacent organ; furthermore, saline serves as an EUS contrast agent (negative) and is detected by EUS.Therefore, we envisaged that if saline is directly injected into extraesophageal space, the separation between the esophageal adventitia and its adjacent organs (especially the thoracic aorta, arcus aortae, and tracheal bifurcation) can be observed by EUS. In our recent experiment in canine model, guided by EUS,extraesophageal saline injection was successfully conducted and saline separated esophageal adventitia from adjacent organs including thoracic aorta, arcus aortae, trachea and bronchial bifurcation without any complication.
研究の種類
入学 (予想される)
段階
- フェーズ 1
連絡先と場所
研究場所
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Guangdong
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Guangzhou、Guangdong、中国、510060
- Sun Yat-sen University Cancer Center
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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
Inclusion Criteria:
A)Age ranges 18-65 years old, no gander limited;
B)Patients with advanced ESCC (T2-T4) who were confirmed by standard endoscopy and pathologic biopsy;
C)Patients who agree to accept esophagectomy;
D)Patients with normal cardio-pulmonary and blood coagulation function; patients were predicted to be tolerated anesthesia and surgery;
E)Patients who understand the study, are willing to join this study and sign consent inform;
Exclusion Criteria:
- Patients with early ESCC of Tis,T1a and T1b stages detected by standard EUS;
- Patients cannot tolerate endoscopy and esophagectomy with various reasons;
- Patients who have distant metastatic disease or multiple source of malignant tumor;
- Patients with blood coagulation disorder;
- Patients don't accept endoscopic or surgical resection subsequently;
- Patients with poor compliancy.
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:診断
- 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:Extraesophageal saline injection (ESI)
Extraesophageal saline injection (ESI) guided by EUS in patients with advanced ESCC preoperatively
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The patients with advanced ESCC are to undergo extraesophageal injection of 15ml saline preoperatively and subsequently detected by EUS to confirm whether saline separates esophagus from adjacent organs.
他の名前:
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of participants with adverse events
時間枠:10 days
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Adverse events included bleeding due to great vessel split, asphyxia, esophageal perforation, acute heart failure or acute mediastinum inflammation during/post ESI.
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10 days
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Efficacy of extraesophageal saline separating esophagus from adjacent organs detected by EUS or computerized tomography (CT) just after ESI
時間枠:30 minutes
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30 minutes
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Jian-jun Li, MD & PhD、Sun Yat-sen University
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- ESI-2013
- 2012-FXY-006 (その他の識別子:The ethic committee of Sun Yat-sen University Cancer Center)
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