食道がんによる食道切除術後の吻合部漏出を防ぐ管腔内真空療法 (ESPY)
食道がんによる食道切除術後の吻合部漏出を防ぐための先制腔内真空療法を評価するための前向き、多施設共同、探索的および観察的ワンアーム研究
A prospective, multi-centre, exploratory and observational one-arm study to evaluate preventive Endoluminal Vacuum Therapy(pEVT) to prevent anastomotic leakage after esophagectomy due to esophageal cancer. The main objective is to evaluate the potential protective effect of prophylactic preemptive endoluminal vacuum therapy on esophageal-gastric anastomosis dehiscence after esophagectomy.
調査の概要
詳細な説明
Prospective, multi-centre, exploratory and observational one-arm study to evaluate preemptive endoluminal vacuum therapy to prevent anastomotic leakage after esophagectomy due to esophageal cancer.
The study comprises a maximum of 5 visits per protocol. At visit 0, informed consent will be obtained, and the patient will be checked for compliance with all inclusion criteria and no exclusion criteria in the study. Demographic characteristics, medical history and oncological parameters will be collected. At visit 1 ttMILE will be carry out and immediately (0-24h) after completion of the anastomosis, in patients who meet selection criteria, the Eso-SPONGE® will be placed endoscopically via an overtube, as usual clinical practice of the centre. The tube will be routed transnasally and then connected to a vacuum pump, generating a continuous negative pressure of 75 mmHg. The Eso-SPONGE system will be checked 6-hourly for leakage and dislocation. The sponge will be removed after 4-6 days (V2). After removal, the anastomosis and the gastric tube will be assessed endoscopically to exclude leakage and evaluate ischemia and stenosis, and the pylorus will be evaluated for spasm. The next visits (V3 and V4) will be carried out at 30 and 90 days after the intervention has been placed. Leakage, ischemia and stenosis will be clinically evaluated at each visit and a new endoscopy will be performed in patient who show symptoms.
研究の種類
入学 (推定)
連絡先と場所
研究場所
-
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Catalonia
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Barcelona、Catalonia、スペイン、08036
- Hospital Clinic de Barcelona
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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
サンプリング方法
調査対象母集団
Patients undergoing a total minimally invasive (laparoscopic or robotic and thoracoscopic) transthoracic Ivor Lewis esophagectomy (ttMILE) due to esophageal cancer and subsequent eso-SPONGE® application to prevent anastomotic leakage (AL)
説明
Inclusion Criteria:
- Age ≥ 18 years
- Scheduled for total minimally invasive (laparoscopic or robotic and thoracoscopic) transthoracic Ivor Lewis esophagectomy (ttMILE) due to esophageal cancer and subsequent eso-SPONGE application to prevent anastomotic leakage
- Patients able to read and understand the Patient Information Sheet and sign, if accepted, the Informed Consent Form
- Patients able, at the discretion of the investigator, to comply with the requirements of the study and without impediments to follow the instructions and assessments throughout the study.
Exclusion Criteria:
- Patients undergoing transhiatal esophagectomy without reconstruction, open Ivor Lewis esophagectomy or other esophageal resections different to ttMILE.
- Multi-organ resection during the esophagectomy.
- Emergent-urgent esophagectomy.
- Coloplasty or small bowel plasty.
- Necrotic tissue/gangrene.
- Blood clotting disorder.
- Bleeding esophageal varices.
- Sponge placement required directly on major vessels.
- Patients with known sensitivities or allergies to its components
- Participation in any other clinical trial and use of any drug or experimental device, currently or in the 4 weeks prior to inclusion in the study.
- Women who are pregnant, suspected of being pregnant or breastfeeding.
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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Eso-SPONGE®
endoluminal vacuum therapy to prevent anastomotic leakage after esophagectomy due to esophageal cancer |
minimally invasive treatment and prevention of anastomotic leakages and perforations in the upper gastrointestinal tract (upper GIT)
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 |
|---|---|---|
|
Rate of patients with anastomotic leakage
時間枠：throughout the duration of the study (until last follow-up at postoperative day 90)
|
Anastomotic leakage (AL) is a severe complication following gastric and esophageal surgery. Anastomotic leakage occurs in 5-30% of patients after esophagectomy and may be further complicated by mediastinitis, sepsis, multiple organ failure, or death. The primary objective of the study is to evaluate the potential protective effect of prophylactic preemptive endoluminal vacuum therapy on esophageal-gastric anastomosis dehiscence after esophagectomy. |
throughout the duration of the study (until last follow-up at postoperative day 90)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Comprehensive Complication Index
時間枠：Postoperative day 30 and day 90
|
The Comprehensive Complication Index (CCI®) calculates the overall morbidity of a patient after any surgical intervention based on the complication grading by the "Clavien-Dindo Classification" (CDC). The Comprehensive Complication Index (CCI®) reflects the gravity of this overall complication burden on the patient on a scale from 0 (no complication) to 100 (death). |
Postoperative day 30 and day 90
|
|
Description of Adverse Events
時間枠：throughout the duration of the study (until last follow-up at postoperative day 90)
|
All the Adverse Events reported during the study will be described together with their characteristics, noting those related with the investigational device application. |
throughout the duration of the study (until last follow-up at postoperative day 90)
|
|
Rate of postoperative ischemia
時間枠：Postoperative day 30 and day 90
|
The different grades of postoperative ischemia at Visit 1, Visit 2 and Visit 3 |
Postoperative day 30 and day 90
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|
Rate of postoperative mortality
時間枠：Postoperative day 30 and day 90
|
The percentage of patients who died along the study will be described in terms of absolute and relative frequencies, as well as causes for death and time until death regarding investigational device application. |
Postoperative day 30 and day 90
|
|
Rate of postoperative stenosis
時間枠：throughout the duration of the study (until last follow-up at postoperative day 90)
|
The percentage of postoperative stenosis at Visit 1, Visit 2 and Visit 3, as well as along the study |
throughout the duration of the study (until last follow-up at postoperative day 90)
|
|
Length of hospitalization
時間枠：until discharge (approximately 10 days postoperatively)
|
time elapsed until reaching the "fit for discharge criteria" regarding investigational device application |
until discharge (approximately 10 days postoperatively)
|
|
Re-admissions to hospital
時間枠：throughout the duration of the study (until last follow-up at postoperative day 90)
|
The percentage of patients re-admitted along the study will be described; as well as the time elapsed until re-admission regarding investigational device application |
throughout the duration of the study (until last follow-up at postoperative day 90)
|
|
Surgical reoperations
時間枠：throughout the duration of the study (until last follow-up at postoperative day 90)
|
The percentage of patients with surgical reoperations along the study will be described; as well as the time elapsed until surgical reoperation regarding investigational device application |
throughout the duration of the study (until last follow-up at postoperative day 90)
|
|
Anastomotic leakage free survival
時間枠：throughout the duration of the study (until last follow-up at postoperative day 90)
|
Event free survival at 30 days and at 90 days will be analyzed using Kaplan-Meier method, considering the anastomotic leakage reported during the study. Patients with no anastomotic leakage during the analyzed period will be censored at last follow-up date |
throughout the duration of the study (until last follow-up at postoperative day 90)
|
|
Rate of intraluminal hemorrhage
時間枠：throughout the duration of the study (until last follow-up at postoperative day 90)
|
The percentage of patients with intraluminal hemorrhage along the study will be described in terms of absolute and relative frequencies; as well as the time elapsed until hemorrhage regarding investigational device application. Additionally, to see the distribution of the time until intraluminal hemorrhage Kaplan-Meier method will be performed at 90 days (patients with no intraluminal hemorrhage during the study will be censored at last follow-up date). |
throughout the duration of the study (until last follow-up at postoperative day 90)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Dulce Momblán García, Dr.、Hospital Clinic of Barcelona
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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