A Longitudinal Cohort Study on the Changes of Physiological Mechanisms in Children After Biliary Tract Reconstruction

Обзор

Through observational studies, the long-term changes in liver function, metabolic state, immune response and other aspects of children after biliary tract reconstruction during their growth process were systematically explored. The risks of these long-term physiological changes on chronic diseases such as cardiovascular diseases, diabetic diseases and liver cirrhosis in adulthood, as well as their impacts on cognitive function, musculoskeletal health and other aspects were evaluated. How do early physiological changes affect a patient's long-term health? Are there any potential biomarkers that can predict future health outcomes? Based on the research results, preventive and intervention measures that are helpful in reducing the risk of long-term complications are proposed.

Первичные конечные точки

• Targeted metabolic component detection of feces [Срок оценки: Baseline (pre-operative); 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years post-operative]
• Detection of targeted metabolic components in plasma [Срок оценки: Baseline (pre-operative); 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years post-operative]

Вторичные конечные точки (1)

• Fecal metagenomic sequencing [Срок оценки: Baseline (pre-operative); 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years post-operative]

Критерии участия

Критерии включения

• Healthy children matched by age and gender were selected as the control group

Критерии исключения

• Combined with other serious diseases (such as cancer, autoimmune diseases), having obvious liver function abnormalities before surgery or being undergoing other major treatments.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 3 центра

• Wuhan Children's Hospital — Ухань
• Wuhan Children'S Hospital — Ухань
• Wuhan Children'S Hospital — Ухань

Публикации

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• Nguyen SH, Abella M, Gutierrez JV, Tabak B, Puapong D, Johnson S, Woo RK. Robotic Surgery for Pediatric Choledochal Cysts: An American Case Series and Literature Review. J Surg Res. 2023 Nov;291:473-479. doi: 10.1016/j.jss.2023.06.034. Epub 2023 Jul 31. PMID 37531675
• Scharli A, Bettex M. Congenital choledochal cyst: reconstruction of the normal anatomy. J Pediatr Surg. 1968 Oct;3(5):604-7. doi: 10.1016/0022-3468(68)90113-9. No abstract available. PMID 5681670

Идентификаторы

NCT: NCT07530354 · Wuhan Children's Hospital

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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