Stool Card in Biliary Atresia
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: Stool Color Card, Biliary Atresia. Базовые параметры: 1 Day — 90 Days · 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
Evaluation of the Effectiveness of Stool Color Card in the Early Detection of Biliary Atresia: A Prospective Study.
Обзор
To evaluate the effectiveness of using a stool color card as a non-invasive screening tool for the early detection of biliary atresia, with the objective of improving early diagnosis rates and facilitating timely surgical intervention.
Подробное описание
Biliary atresia (BA) is a rare but life-threatening liver disorder that affects infants, characterized by the progressive inflammation and fibrosis of the bile ducts, leading to biliary obstruction \[1\].
Early diagnosis and intervention are crucial - ideally before 60 days of age - as BA is a leading cause of liver transplantation in children if not diagnosed and treated promptly \[2\]. The traditional method of diagnosis involves the identification of clinical signs like jaundice and abnormal liver function tests, but this approach can delay the diagnosis, leading to irreversible liver damage. As a result, early detection is essential to improve outcomes and prevent the need for a liver transplant \[3\].
The stool color card (SCC) is a diagnostic tool that has gained significant attention in recent years as a non-invasive method for the early detection of biliary atresia \[4\]. Newborns with biliary atresia typically exhibit pale stools due to a lack of bile secretion \[5\].
The stool color card provides a simple way for parents or healthcare professionals to monitor changes in the stool color in newborns, providing an early indicator of potential biliary atresia \[6,7\]. The card features a range of colors that correspond to the different stages of stool color, allowing for easy comparison and identification of abnormal stool \[8-11\].
Despite the availability of SCCs, their effectiveness in routine screening programs remains understudied. There is a need to evaluate the utility of SCCs in improving early diagnosis rates of BA.
Первичные конечные точки
- Effectiveness of Stool Color Card in Early Detection of Biliary Atresia [Срок оценки: First 3 months]
Критерии участия
Критерии включения
- Neonates and infants aged 1-90 days old.
- Neonates and infants with direct (conjugated) hyperbilirubinemia (Conjugated hyperbilirubinemia is generally defined as a conjugated or direct bilirubin level greater than 1 mg/dL when the total bilirubin is less than 5 mg/dL or more than 20% of the total bilirubin if the total bilirubin is greater than 5 mg/dL) \[12\]
- No contraindication for liver biopsy as considered the gold standard for diagnosis of biliary atresia e.g. coagulopathy.
Критерии исключения
1 - Infants diagnosed with biliary atresia or other cholestatic liver diseases prior to enrollment.
2-Infants aged more than 90 days 3-Neonates and infants with indirect hyperbilirubinemia. 4-Those with contraindication to do liver biopsy
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.
Публикации
- Gu YH, Yokoyama K, Mizuta K, Tsuchioka T, Kudo T, Sasaki H, Nio M, Tang J, Ohkubo T, Matsui A. Stool color card screening for early detection of biliary atresia and long-term native liver survival: a 19-year cohort study in Japan. J Pediatr. 2015 Apr;166(4):897-902.e1. doi: 10.1016/j.jpeds.2014.12.063. Epub 2015 Feb 11. PMID 25681196
- Feldman AG, Sokol RJ. Neonatal Cholestasis. Neoreviews. 2013 Feb 1;14(2):10.1542/neo.14-2-e63. doi: 10.1542/neo.14-2-e63. PMID 24244109
- Madadi-Sanjani O, Kuebler JF, Uecker M, Pfister ED, Baumann U, Kunze-Hullmann B, Blaser J, Buck T, Petersen C. Province-Wide Stool Color Card Screening for Biliary Atresia in Lower-Saxony: Experiences with Passive Distribution Strategies and Results. Int J Neonatal Screen. 2021 Nov 4;7(4):75. doi: 10.3390/ijns7040075. PMID 34842600
- Alam R, Nahid KL, Faruk MO, Rasna EH, Rukunuzzaman M. Use of stool color card as screening tool for biliary atresia in resource-constraint country. Gastroenterol Hepatol Bed Bench. 2024;17(2):146-150. doi: 10.22037/ghfbb.v17i2.2931. PMID 38994513
- El-Shabrawi MH, Baroudy SR, Hassanin FS, Farag AE. A pilot study of the value of a stool color card as a diagnostic tool for extrahepatic biliary atresia at a single tertiary referral center in a low/middle income country. Arab J Gastroenterol. 2021 Mar;22(1):61-65. doi: 10.1016/j.ajg.2020.12.004. Epub 2021 Mar 2. PMID 33664005
- Schreiber RA, Harpavat S, Hulscher JBF, Wildhaber BE. Biliary Atresia in 2021: Epidemiology, Screening and Public Policy. J Clin Med. 2022 Feb 14;11(4):999. doi: 10.3390/jcm11040999. PMID 35207269
- Rabbani T, Guthery SL, Himes R, Shneider BL, Harpavat S. Newborn Screening for Biliary Atresia: a Review of Current Methods. Curr Gastroenterol Rep. 2021 Nov 24;23(12):28. doi: 10.1007/s11894-021-00825-2. PMID 34817690
Идентификаторы
NCT: NCT07139717 · Stool card in biliary atresia