Меню
Идёт набор NCT07321431

The Optimal Measurement Time for the New Gallbladder Function Assessment Method

Без фазы С лечением Gallbladder; Functional Disturbance

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: oral administration of 2 fried eggs, oral protein bars + 50ml olive oil.
Кому может быть актуально
Состояния в реестре: Gallbladder; Functional Disturbance. Базовые параметры: 18 лет — 70 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
Китай
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

The Optimal Measurement Time for the New Gallbladder Function Assessment Method: A Prospective, Multicenter, Double-Blind, Crossover Trial

Обзор

This is a multicenter, prospective, randomized, double-blind, crossover study involving healthy individuals, aiming to evaluate the stability of oral protein bars + olive oil as a new method for determining gallbladder contraction function and its optimal diagnostic time window.

Подробное описание

This is a multicenter, prospective, randomized, single-blind, crossover study involving healthy individuals. This study will use a crossover trial method to compare oral fried eggs with oral protein bars + olive oil. Gallbladder ultrasound examinations will be performed at different time points to measure gallbladder volume, and the changes in gallbladder contraction rates at different time points under the two interventions will be calculated to determine the optimal time window for assessing gallbladder contraction function. On the other hand, the investigators will verify the stability of oral protein bars plus olive oil as a new method for measuring gallbladder contraction function, evaluate its reliability and reproducibility across different regions, hospitals, and populations, ensure its wide clinical application, and provide stronger support for the diagnosis and treatment of gallbladder-related diseases.

Вмешательства

  • Пищевая добавка oral administration of 2 fried eggs
    First, the intervention of oral administration of 2 fried eggs is carried out. The size of the gallbladder is evaluated by ultrasound examination. The washout period is 1 week. After that, the first intervention process of group B is repeated.
  • Пищевая добавка oral protein bars + 50ml olive oil
    First, an intervention with oral protein bars + 50ml olive oil is conducted. The size of the gallbladder is evaluated through ultrasound examination. The washout period is 1 week. After that, the first intervention process of Group A is repeated.

Первичные конечные точки

  • Gallbladder Volume [Срок оценки: during procedure]
  • Gallbladder contraction rate [Срок оценки: during procedure]
Вторичные конечные точки (3)
  • Presence of Abdominal [Срок оценки: 30 days]
  • Occurrence of Acute Pancreatitis [Срок оценки: 30 days]
  • Occurrence of Gastrointestinal Bleeding Post-Intervention [Срок оценки: 30 days]

Критерии участия

Критерии включения

  • Ultrasound assessment identifies people with normal biliary tract structure.

Критерии исключения

  • History of Endoscopic Retrograde Cholangiopancreatography
  • Previous gallstone removal surgery with gallbladder preservation
  • Other biliary tract diseases and related surgical history
  • History of acute or chronic pancreatitis
  • History of gastrointestinal surgery
  • Gastrointestinal obstruction
  • Dysfunction of the sphincter of Oddi
  • Gallbladder neck polyps
  • Abnormal gallbladder structure
  • Gallbladder mass
  • Biliary infection or stones
  • Congenital biliary abnormalities
  • Biliary injury or surgery
  • Biliary tumors
  • Gastrointestinal bleeding, liver cirrhosis, or other malignant diseases
  • Significant arrhythmia, bradycardia, or atrioventricular block
  • Severe hypertension, liver or kidney insufficiency
  • Immune, endocrine, hematological, or mental disorders
  • Severe cerebrovascular disease
  • Allergy to relevant foods
  • Pregnant or breastfeeding women
  • Unwillingness or inability to consent to participation

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Двойное слепое
Основная цель
Диагностика

Центры проведения

Китай · 5 центров
  • Hepatopancreatobiliary Surgery Institute of Gansu Province — Lanzhou
  • The First Hospital of Qinhuangdao — Qinhuangdao
  • The Jinqiu Hospital of Liaoning Province — Шэньян
  • People's Hospital of Ningxia Hui Autonomous Region — Иньчуань
  • Honghui Hospital of Xi'an Jiaotong University — Xi’an

Публикации

  • Ai XN, Wang TF, Zhang Q, Ouyang CG, Wu ZY. Changes in Gallbladder Contractile Function and its Influencing Factors After Minimally Invasive Gallbladder-Preserving Surgery for Cholecystitis With Incarcerated Gallstones. Front Surg. 2022 Jul 14;9:926141. doi: 10.3389/fsurg.2022.926141. eCollection 2022. PMID 35910468
  • Rehfeld JF. Clinical endocrinology and metabolism. Cholecystokinin. Best Pract Res Clin Endocrinol Metab. 2004 Dec;18(4):569-86. doi: 10.1016/j.beem.2004.07.002. PMID 15533776

Идентификаторы

NCT: NCT07321431 · GB evaluating

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗