Эндолюминальная вакуумная терапия для предотвращения несостоятельности анастомоза после эзофагэктомии по поводу рака пищевода (ESPY)
Проспективное, многоцентровое, исследовательское и обсервационное исследование с использованием одной руки для оценки упреждающей внутрипросветной вакуумной терапии для предотвращения несостоятельности анастомоза после эзофагэктомии по поводу рака пищевода
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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Места учебы
-
-
Catalonia
-
Barcelona, Catalonia, Испания, 08036
- Hospital Clinic de Barcelona
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
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)
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: COHORT
- Временные перспективы: PROSPECTIVE
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
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)
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Rate of patients with anastomotic leakage
Временное ограничение: 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)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Comprehensive Complication Index
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
|
Rate of postoperative mortality
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Dulce Momblán García, Dr., Hospital Clinic of Barcelona
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Послеоперационные осложнения
- Патологические процессы
- Новообразования по локализации
- Новообразования
- Желудочно-кишечные новообразования
- Новообразования пищеварительной системы
- Заболевания пищеварительной системы
- Желудочно-кишечные заболевания
- Новообразования головы и шеи
- Заболевания пищевода
- Патологические состояния, признаки и симптомы
- Новообразования пищевода
- Анастомотическая утечка
Другие идентификационные номера исследования
- AAG-O-H-2209
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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