Ivor Lewis 食道切除術後のステープル円形食道胃吻合における OBSiDiAN (Obsidian ph II)
多施設無作為対照試験における Ivor Lewis 食道切除術後のステープル環状食道胃吻合を強化するための自家 BioMatrix OBSiDiAN の有効性と安全性の評価。
Oesophagectomy is very invasive surgery. A leakage at the level of the connection between oesophagus and stomach made during surgery causes a lot more problems and can lead to death. Studies show that the leakage rate sometimes goes up to 40 per cent. The chance of dying if you develop a leak after surgery is 15%, while the overall chance of dying during hospitalisation for this procedure is about 4%. We want to investigate whether the use of this new type of 'glue' (Obsidian®) can reduce the number of leaks. We invite you to participate in a clinical trial with the aim of investigating whether Obsidian® is safe and can reduce the number of leaks after oesophageal surgery in patients with oesophageal cancer. We want to apply a new type of 'glue', Obsidian®, at the level of the new connection between oesophagus and stomach.
調査の概要
詳細な説明
STUDY PRODUCT Autologous BioMatrix: Obsidian (medical device class III)
STUDY POPULATION Subjects ≥ 18 years and ≤ 75 years of age scheduled for elective Ivor Lewis esophagectomy for esophageal cancer with a circular stapled intrathoracic esophagogastric anastomosis.
SAMPLE SIZE A total of 90 patients will be included in the study. ENROLEMENT PERIOD Based on an annual number of 70-80 esophagectomies in University Hospital Ghent, we predict an enrolment period of 3 years.
STUDY DURATON Considering a 3 years enrolment period and a 1 year follow up we predict a study duration of 4 years.
PRIMAIRY ANALYSIS
• Anastomotic leak within 30 days post operatively. Anastomotic leak type I, II and III is defined according to the Esophagectomy Complications Consensus Group (ECCG).
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Hanne Vanommeslaeghe
- 電話番号：+3293325945
- メール：hanne.vanommeslaeghe@uzgent.be
研究場所
-
-
East-Flanders
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Ghent、East-Flanders、ベルギー、9000
- 募集
- University Hospital Ghent
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コンタクト：
- Hanne Vanommeslaeghe, MD
- 電話番号：00323325945
- メール：hanne.vanommeslaeghe@uzgent.be
-
Ghent、East-Flanders、ベルギー、9000
- まだ募集していません
- University Hospital Ghent
-
コンタクト：
- Hanne Vanommeslaeghe, MD
- 電話番号：00323325945
- メール：hanne.vanommeslaeghe@uzgent.be
-
-
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 Preoperatively
- Subjects ≥ 18 years and ≤ 75 years who are willing to participate and provide written informed consent prior to any study-related procedures.
- Subjects with esophageal carcinoma (distal until Siewert II) scheduled for elective minimally invasive Ivor Lewis esophagectomy (cT1-4a,N0-3,M0).
Intra-operatively
- Intrathoracic circular stapled esophagogastric anastomosis
-
Exclusion criteria preoperatively
- Female patients who are pregnant or nursing
- Participation in another study involving investigational drugs or devices.
- Use of Avastin within 30 days prior to surgery
- ASA IV (patient with severe systemic disease that is a constant threat to life)
- Patients with other malignancies
- Patients with previous esophageal or gastric surgery
- Known hypersensitivity to batroxobin and tranexamic acid.
- HB level < 8 g/dL
- Patients on medicine containing acetylsalicylic acid not able to stop using the medicine for medical reasons minimum 3 days before taking the blood sampling.
- Patients on clopidogrel not able to stop clopidogrel for medical reasons 7 days before blood sampling
- Patients on other platelet aggregation inhibitor therapies not able to stop using the platelet aggregation inhibitor therapies for 3 days before taking the blood sample.
Intra-operatively
- Intra-operative findings that may preclude conduct of the study procedures, such as pleural metastasis, tumor invasion in other organs, …
- Anastomosis preformed differently than the standard of care
- Excessive bleeding (>500 ml) prior to anastomosis
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 |
|---|---|
|
実験的：study group
For the study group, a unit of autologous BioMatrix OBSiDiAN will be produced. Blood sample (120ml) will be taken after randomization at the ending of the abdominal phase of the surgery. The surgeon will create an esophagogastric anastomosis, after ruling out tension or torsion. Around 1-2ml of autologous BioMatrix OBSiDiAN will be applied on the distal/or proximal resection stump before the stapled anastomose will be created. After firing the standard circular device and creation of a functional anastomosis, a further 2.5-3ml OBSiDiAN must be applied circumferentially on the outside on the anastomosis. Once application is completed, a 30 seconds waiting period is required before putting the esophagus back into the surgical field (study specific). A methylene blue leakage test or other leakage test is performed (standard of care). If there is a leak, the anastomosis will be corrected or the completed procedure has to be done again. |
To create OBSiDiAN BioMatrix, 120 ml of the the patient's blood is added to the processing unit. The Vivostat® processor unit heats, separates, centrifugates to get the plasma. Batroxobin is added. After again processing, the result is an OBSiDian syringe filled with BioMatrix Obsidian®ASG. This will be applied on the anastomosis |
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 |
|---|---|---|
|
Anastomotic leak
時間枠：Absence of anastomotic leak within 30 days post operatively
|
Anastomotic leak defined according to the ECCG guidelines type I: local defect requiring no change in therapy or treated medicallly or with dietary modifications type II: localized defect requiring interventional but not surgical therapy, for example, interventional radiology drain, stent or bedside opening and packing or incision type III: localized defect requiring surgical therapy |
Absence of anastomotic leak within 30 days post operatively
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
mortality
時間枠：from surgery until 30 days post operative
|
in hospital mortality |
from surgery until 30 days post operative
|
|
sepsis
時間枠：from surgery until 30 day post operative
|
in hospital sepsis |
from surgery until 30 day post operative
|
|
pneumonia
時間枠：from surgery until 30 day post operative
|
in hospital pneumonia |
from surgery until 30 day post operative
|
|
late anastomotic leakage
時間枠：from surgery until 90 days post operative
|
late anastomotic leakage (ECCG type I, II and III) |
from surgery until 90 days post operative
|
|
stricture
時間枠：from surgery until 1 year post operative
|
stricture of the esophagogastric anastomosis |
from surgery until 1 year post operative
|
|
inflammation WBC
時間枠：from date of randomisation to postoperative day 5
|
post operative inflammation (WBC) |
from date of randomisation to postoperative day 5
|
|
inflammation CRP
時間枠：from date of randomisation to postoperative day 5
|
post operative inflammation (CRP) |
from date of randomisation to postoperative day 5
|
|
ICU stay
時間枠：from surgery until discharge or until the date of death from any cause, whichever came first, assessed up to 3 months
|
length of ICU stay |
from surgery until discharge or until the date of death from any cause, whichever came first, assessed up to 3 months
|
|
hospital stay
時間枠：from surgery until discharge or until the date of death from any cause, whichever came first, assessed up to 3 months
|
total hospital stay |
from surgery until discharge or until the date of death from any cause, whichever came first, assessed up to 3 months
|
|
thoracic drainage volume
時間枠：from surgery until removal of thoracic drain within the first week postoperative
|
Volume of thoracic drain |
from surgery until removal of thoracic drain within the first week postoperative
|
|
thoracic drainage duration
時間枠：from surgery until removal of thoracic drain within the first week postoperative
|
duration of thoracic drain |
from surgery until removal of thoracic drain within the first week postoperative
|
|
intra-operative checklist
時間枠：peroperative
|
|
peroperative
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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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