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Набор скоро начнётся NCT07129447

Feasibility and Safety Evaluation of Endoscopic Treatment of Esophagogastric Varices in Cirrhosis on the Day-care Unit

— Наблюдательное Liver Cirrhosis Gastroesophageal Varices

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: Liver Cirrhosis, Gastroesophageal Varices. Базовые параметры: 18 лет — 75 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Feasibility and Safety Assessment of Endoscopic Treatment of Esophagogastric Variceal Bleeding in Cirrhosis on the Day Unit: a Single-centre, Prospective-historical Controlled Study

Обзор

The goal of this observational study is to learn about the feasibility and safety evaluation of endoscopic treatment of esophagogastric varices in cirrhosis on the day-care ward. The main question it aims to answer is: Is inpatient endoscopic treatment on day wards also feasible and safe for patients with esophagogastric variceal bleeding in cirrhosis when compared to inpatient endoscopy on a general ward? Participants undergoing inpatient endoscopic treatment for cirrhotic esophagogastric variceal bleeding on day wards and general wards will answer online survey questions about their postoperative period over a 1-year period.

Подробное описание

Our project team found that for patients with varicose veins treated with re-endoscopy during sequential treatment, day ward treatment can also achieve the goal of eradicating varicose veins, reducing bleeding, and shortening the number of days in the hospital, reducing hospitalization costs, and increasing the satisfaction of the patient's visit. This study was a single-center, prospective-historical controlled study that prospectively included study participants who underwent reendoscopic treatment of cirrhotic esophagogastric varices who presented to the gastroenterology day unit of our hospital from May 2025 to December 2028 and were followed up until the death of the study participant or the end of the study, with a follow-up period of 1 year. Retrospectively included study participants who underwent reendoscopic treatment for cirrhotic esophagogastric varices who presented to the gastroenterology department of our hospital between October 2023 and October 2024, screened study participants as controls according to propensity score matching and a 1:1 ratio, and followed prospectively until the death of the study participants or the end of the study, with a follow-up period of 1 year. The key scientific question of the study was to assess whether re-endoscopic treatment of bleeding esophagogastric varices in cirrhosis on day wards is feasible and safe. The objective of the study was to assess the feasibility and safety of reendoscopic treatment of cirrhotic esophagogastric variceal bleeding on day wards.

Первичные конечные точки

  • Variceal rebleeding rate at 1-year follow-up after enrollment [Срок оценки: 1 years]
Вторичные конечные точки (5)
  • Varicose vein recurrence rate within 1 year of follow-up after enrollment [Срок оценки: 1 years]
  • Mortality Rate Within 1 Year of Follow-Up After Enrollment [Срок оценки: 1 years]
  • Incidence of Overt Hepatic Encephalopathy (HE) Within 1 Year of Follow-Up After Enrollment [Срок оценки: 1 years]
  • Hospitalization Duration [Срок оценки: 1 years]
  • Hospitalization Cost [Срок оценки: 1 years]

Критерии участия

Критерии включения

  • aged 18-75 years;
  • diagnosis of cirrhosis and portal hypertension by clinical manifestations, laboratory tests, imaging tests and histologic examinations;
  • gastroscopic grading of esophagogastric varices as moderate or severe;
  • no ruptured esophagogastric varices bleeding in the last 5 days;
  • endoscopic treatment of esophagogastric varices during hospitalization.

Критерии исключения

  • first endoscopic treatment of esophagogastric varices;
  • this is an acute esophagogastric variceal rupture and bleeding;
  • previous TIPS or liver transplantation;
  • isolated fundal varices or ectopic varices;
  • primary hepatocellular carcinoma or acute or chronic hepatic failure, Child-pugh class C, hepatic encephalopathy stage 2 or higher;
  • spontaneous abnormally large shunts, uncontrolled infections and sepsis, uncontrolled hypertension;
  • combined cardiac, pulmonary, cerebral, renal and other serious complications or other reasons for not being able to tolerate the examination;
  • pregnant women and lactating women;
  • failure to sign the informed consent or refusal to participate.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07129447 · 20250415-QiluH

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗