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Идёт набор NCT06925204

Natural Course and Therapeutic Effect of Chronic Pancreatitis

— Наблюдательное Chronic Pancreatitis

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: Observation.
Кому может быть актуально
Состояния в реестре: Chronic Pancreatitis. Базовые параметры: Без ограничений · 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 →

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Официальное название

Natural Course and Therapeutic Effect of Chronic Pancreatitis: a Prospect Cohort Study

Обзор

The goal of this observational study is to establish a prospective cohort of chronic pancreatitis (CP) patients to provide evidence-based guidance for clinical practice and comprehensively optimize diagnostic and treatment strategies. The study aims to collect detailed demographic information, clinical data, medical imaging, biological samples, and follow-up information from CP patients.

Подробное описание

Chronic pancreatitis (CP) is clinically characterized by abdominal pain and pancreatic dysfunction, including diabetes and steatorrhea, which significantly impact patients' quality of life and life expectancy. Globally, the annual incidence of CP is 9.62 per 100,000 individuals, with a mortality rate of 0.09 per 100,000 and a prevalence ranging from 13.5 to 560 per 100,000. In China, the prevalence of CP has also been increasing annually, currently reaching 13.52 per 100,000 individuals. In most countries worldwide, the incidence and prevalence of CP are generally on the rise, leading to an increasing healthcare burden. Due to the endocrine and exocrine functions of the pancreas, CP presents with highly variable clinical symptoms, diverse complications, and a risk of malignant transformation. Therefore, establishing a standardized, large-scale, long-term follow-up prospective cohort for CP is crucial for a more comprehensive understanding of its clinical characteristics and for providing high-quality evidence-based medical guidance for clinical practice.

Вмешательства

  • Другое Observation
    Based on the patient's specific clinical condition, the appropriate examination and treatment in accordance with the conventional diagnosis and treatment standards of CP will be performed, including but not limited to: CT, MRI, endoscopic ultrasound (EUS) with or without biopsy, endocrine hormone testing (such as oral glucose tolerance test or mixed meal tolerance testing), pancreatic exocrine function tests (such as fecal elastase-1 test), extracorporeal shock wave lithotripsy (ESWL), endoscopi

Первичные конечные точки

  • Incidence of complications [Срок оценки: Annually for 10 years post-enrollment (Year 1 through Year 10)]
Вторичные конечные точки (6)
  • Incidence of pancreatic cancer [Срок оценки: 5 and 10 years after enrollment]
  • Efficacy of endoscopic treatment [Срок оценки: 1 year after treatment]
  • Scores of quality of life [Срок оценки: Annually for 10 years post-enrollment (Year 1 through Year 10)]
  • HbA1c level [Срок оценки: Baseline and Year 1 to Year 10 post-enrollment (annually)]
  • Blood glucose profile characteristics [Срок оценки: Baseline and Year 1 to Year 10 post-enrollment (annually)]
  • Pancreatic and gut hormone levels [Срок оценки: Baseline and Year 1 to Year 10 post-enrollment (annually)]

Критерии участия

Критерии включения

  • Patients diagnosed with chronic pancreatitis.

Критерии исключения

  • Patients who refuse to sign informed consent.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Changhai Hospital — Шанхай

Публикации

  • Kichler A, Jang S. Chronic Pancreatitis: Epidemiology, Diagnosis, and Management Updates. Drugs. 2020 Aug;80(12):1155-1168. doi: 10.1007/s40265-020-01360-6. PMID 32647920
  • Oh TK, Song IA. Five-year mortality trends associated with chronic pancreatitis in South Korea: A population based cohort study. Pancreatology. 2020 Jul;20(5):828-833. doi: 10.1016/j.pan.2020.04.024. Epub 2020 Jun 18. PMID 32646739
  • Sellers ZM, MacIsaac D, Yu H, Dehghan M, Zhang KY, Bensen R, Wong JJ, Kin C, Park KT. Nationwide Trends in Acute and Chronic Pancreatitis Among Privately Insured Children and Non-Elderly Adults in the United States, 2007-2014. Gastroenterology. 2018 Aug;155(2):469-478.e1. doi: 10.1053/j.gastro.2018.04.013. Epub 2018 Apr 13. PMID 29660323
  • Wang LW, Li ZS, Li SD, Jin ZD, Zou DW, Chen F. Prevalence and clinical features of chronic pancreatitis in China: a retrospective multicenter analysis over 10 years. Pancreas. 2009 Apr;38(3):248-54. doi: 10.1097/MPA.0b013e31818f6ac1. PMID 19034057

Идентификаторы

NCT: NCT06925204 · CCPC

Первоисточники (государственные реестры)

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