Меню
Набор скоро начнётся NCT07343869

Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection

— Наблюдательное Superficial Esophageal Cancer Oesophageal Adenocarcinoma Oesophageal Squamous Cell Carcinoma Barretts Esophagus With Dysplasia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Superficial Esophageal Cancer, Oesophageal Adenocarcinoma, Oesophageal Squamous Cell Carcinoma, Barretts Esophagus With Dysplasia. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Prospective Multicenter Cohort on Esophageal Submucosal Dissection: Evaluation of Technical, Oncological, and Organizational Outcomes in Real-Life Practice

Обзор

In France in 2018, there were an estimated 2,074 new cases of esophageal adenocarcinoma and 3,224 cases of squamous cell carcinoma. The estimated deaths from esophageal cancer were 3,725, with a standardized 5-year net survival rate of 20% for cases diagnosed between 2010 and 2015, mainly due to late diagnosis. Surgery was historically the standard treatment for localized disease but carries significant morbidity. Over the past decade, endoscopic treatments, particularly endoscopic submucosal dissection (ESD), have become the reference approach for superficial esophageal cancers. After endoscopic resection, histological analysis allows classification of recurrence risk into very low, low, and high categories. Predicting lymph node or distant recurrence is complex, depending on factors such as depth of wall infiltration, lymphovascular invasion, and tumor differentiation. The frequent combination of unfavorable histological features may have led to an overestimation of lymph node involvement risk in T1b cancers. ESD is widely performed in France, with over 1,600 procedures reported in 2023 for esophageal and gastric lesions, demonstrating the feasibility of a large observational study. This multicenter French cohort will evaluate technical, oncological, and organizational outcomes of esophageal ESD, including overall survival, recurrence-free survival, and management of residual Barrett's esophagus. It will also identify predictive factors for treatment success, recurrence, and complications, providing real-world evidence to guide patient management.

Первичные конечные точки

  • Recurrence-free survival according to adjuvant treatment [Срок оценки: From enrollment to 5 years]
Вторичные конечные точки (12)
  • R0 resection rate [Срок оценки: From ESD to 5 years]
  • En bloc resection rate [Срок оценки: From ESD to 5 years]
  • Curative resection rate [Срок оценки: From ESD to 5 years]
  • 30-day complication rate [Срок оценки: 30 days post-ESD]
  • Rate of MDTB presentation [Срок оценки: From ESD to 5 years]
  • Concordance between MDTB decision and actual management [Срок оценки: From ESD to 5 years]
  • Rate of patients receiving adjuvant treatment [Срок оценки: From enrollment to 5 years]
  • Rate of complementary Barrett's eradication treatment (radiofrequency or other) [Срок оценки: From ESD to 5 years]
  • Morbidity of complementary treatments [Срок оценки: From ESD to 5 years]
  • Efficacy of complementary treatments [Срок оценки: From complementary treatment to 5 years]
  • Prognostic factors for recurrence (local, regional, metastatic) [Срок оценки: From enrollment to 5 years]
  • Predictive factors for post-ESD complications [Срок оценки: From ESD to 5 years]

Критерии участия

Критерии включения

  • Adults (≥ 18 years old)
  • Patients referred for endoscopic resection of an esophageal lesion and treated by submucosal dissection
  • Patients managed in one of the participating centers
  • Patient who has received oral and written information about the study and has not objected to participation
  • Patients covered by a social security or health insurance scheme.

Критерии исключения

  • Patient refusal after reading the information sheet
  • Patient under legal protection (guardianship, curatorship, court-ordered protection)
  • Inability to inform the patient due to cognitive impairment, language barrier, or medical emergency
  • Patients previously included for another lesion in the same study
  • Pregnant or breastfeeding women.
  • Patient deprived of liberty.
  • Patient currently enrolled in another clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Jules Verne Clinic — Nantes

Идентификаторы

NCT: NCT07343869 · SFED-162

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗