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Набор скоро начнётся NCT05620485

Timing of Operation in Children With a Prenatal Diagnosis of Choledochal Cyst

Без фазы С лечением Choledochal Cyst

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: laparoscopic-assisted CDC excision and hepaticojejunostomy.
Кому может быть актуально
Состояния в реестре: Choledochal Cyst. Базовые параметры: 0 мес. — 3 мес. · 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 →
Официальное название

Timing of Operation in Children With a Prenatal Diagnosis of Choledochal Cyst:A Single-center Prospective Study

Обзор

In this prospective study, we tried to select the operation time according to the cyst size and evaluate the treatment effect.

Подробное описание

A choledochal cyst (CDC) is a congenital anomaly of the biliary system, which is more common in the Asian population. If a CDC is not diagnosed and treated promptly, it often leads to a series of serious complications, including cholangitis, cyst rupture, cholestatic cirrhosis, and even cholangiocarcinoma. Infants with a postnatal diagnosis of CDC often present with symptoms, and to avoid the occurrence of serious complications, operative correction should be performed as soon as possible when their clinical conditions allow. However, in the current era with the improvement of prenatal screening technology, an increasing number of choledochal cysts are diagnosed prenatally in the fetus. In developed countries, as many as 15% of choledochal cysts are found before birth. Some of these children receive intervention when they are asymptomatic at an early stage, while some have progressed to CDC-related symptoms before operative correction. The timing of operation for children with a prenatal diagnosis of CDC remains controversial. The investigators previous study showed that it is more advantageous to receive surgical treatment in the asymptomatic period for patients with prenatally diagnosed CDC. In addition, the age at operation (months) appears to be unrelated to intraoperative and postoperative complications, which is distinct from previous studies. More interestingly, the investigators found that a specific cyst size (length \> 5.2 cm and width \> 4.1 cm) suggested that clinical symptoms might appear and that the surgery should be performed as soon as clinically safe to proceed. Therefore, in this study, the investigators tried to select the operation time according to the cyst size and evaluate the treatment effect.

Вмешательства

  • Процедура laparoscopic-assisted CDC excision and hepaticojejunostomy
    After birth, the liver and gallbladder ultrasound were regularly rechecked. If the maximum diameter of the cyst was greater than 5 cm, surgery was performed.

Первичные конечные точки

  • preoperative complications [Срок оценки: pre-intervention]
  • preoperative complications [Срок оценки: pre-intervention]
  • preoperative complications [Срок оценки: 1 week before surgery]
  • preoperative complications [Срок оценки: 1 week before surgery]
  • preoperative complications [Срок оценки: 1 week before surgery]
  • preoperative complications [Срок оценки: 1 week before surgery]
  • short-term complications [Срок оценки: 1 weak after surgery]
  • short-term complications [Срок оценки: 1 weak after surgery]
  • short-term complications [Срок оценки: 1 weak after surgery]
  • short-term complications [Срок оценки: 1 weak after surgery]
Вторичные конечные точки (3)
  • length of stay [Срок оценки: 1 month after surgery]
  • duration of ventilator support [Срок оценки: 1 month after surgery]
  • length of nutritional support in hospital [Срок оценки: 1 month after surgery]

Критерии участия

Критерии включения

  • Infants with a prenatal and postnatal diagnosis with CDC
  • Prenatal and postnatal hepatobiliary ultrasound data were complete
  • Age of visit < 3 months

Критерии исключения

Unable to tolerate surgery after birth

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05620485 · 521123

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗