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Набор по приглашению NCT06509022

Longitudinal Study on the Evolution Trend and Influencing Factors of Postoperative Reflux of Esophageal Cancer Based on PEPTEST Technique

— Наблюдательное GASTROINTESTINAL NEOPLASMS

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
В протоколе указаны: PEPTEST test.
Кому может быть актуально
Состояния в реестре: GASTROINTESTINAL NEOPLASMS. Базовые параметры: Без ограничений · 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
Китай
Следующий шаг
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Официальное название

China Cancer Foundation Beijing Hope Marathon Fund

Обзор

The goal of this observational study intends to explore the evolution trend and related factors of postoperative reflux of esophageal cancer based on PEPTEST detection, in order to identify postoperative reflux The main question it aims to answer are: to provide evidence for high-risk groups, improvement of surgical methods for esophageal cancer, and development of health education programs to prevent postoperative reflux. Using convenient sampling method, patients undergoing esophagectomy in thoracic surgery Department of Cancer Hospital of Chinese Academy of Medical Sciences from January 1, 2023 were continuously enrolled. PEPTEST was performed once before surgery, before discharge, 1 month, 3 months, and 6 months after surgery. The incidence of pathological reflux at 5 time points before and after surgery was observed and compared (that is, both T-line and C-line were shown). The trend of pepsin content in saliva before and after operation; The relationship between pathological reflux and surgical factors; The relationship between pathological reflux and life habits after operation; Relationship between pathological regurgitation and demographic characteristics.

Подробное описание

The subjects of this study were selected from the patients who underwent esophagectomy in the Department of Thoracic Surgery of Cancer Hospital of Chinese Academy of Medical Sciences from January 1, 2023 to December 1, 2023, and the patients who underwent esophagectomy in the Department of thoracic surgery of Cancer Hospital of Chinese Academy of Medical Sciences from January 1, 2023. PEPTEST was performed once before surgery, before discharge, 1 month, 3 months, and 6 months after surgery. To describe the evolution trend of postoperative reflux in patients with esophageal cancer can be used for anticipatory sexual health education. To explore the relevant factors of reflux: to identify the inherent factors, such as gender, BMI, etc., to give preventive intervention to high-risk groups; The variable factors such as the length and width of the tube stomach can be improved.

Вмешательства

  • Диагностический тест PEPTEST test
    Quantitative determination of gastric salivary amylase。

Первичные конечные точки

  • Incidence of pathological regurgitation [Срок оценки: 2023.1.1-2023.12.1]

Критерии участия

Критерии включения

  • Patients who were pathologically diagnosed with esophageal cancer and underwent esophagectomy for esophageal cancer.
  • The patient can communicate in Mandarin.
  • Those who can come to the hospital for review on time.

Критерии исключения

  • People with cognitive impairment or mental illness.
  • Complicating other serious life-threatening diseases (such as leukemia or autoimmune diseases).
  • Unwilling to participate in the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Пекин

Идентификаторы

NCT: NCT06509022 · NCC4005

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗