Freiburg TIPS Registry
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: Implantation of a transjugular intrahepatic portosystemic shunt (TIPS).
- Кому может быть актуально
- Состояния в реестре: Liver Cirrhosis, Portal Hypertension, Non-Cirrhotic Portal Hypertension, Budd Chiari Syndrome. Базовые параметры: 18 лет — 100 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
- Германия
- 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
Transjugular Intrahepatic Portosystemic Shunt (TIPS) for the Treatment of Portal Hypertension: an Observational Study
Обзор
Patients with clinically significant portal hypertension allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Medicine II of the University Medical Center Freiburg, Germany will be offered to participate in this prospective observational trial. Clinical and laboratory as well as outcome parameters will be assessed before and within the first 12 months after TIPS implantation following a regular follow-up schedule with clinical visits at the University Medical Center Freiburg. During follow-up visits, serum/plasma samples and peripheral blood mononuclear cells (PBMC) are collected and stored in a associated biobank.
Подробное описание
Patients with clinically significant cirrhotic and non-cirrhotic portal hypertension who are allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS) can be included in this observational study. Further patients who have been treated between 01/01/2005 and the start of the prospective part of this study (01/01/2023) will be included retrospectively in this registry.
Patients who are allocated to TIPS implantation will be recruited the day before TIPS implantation. Detailled patient characteristics, epidemiologic, clinical, imaging and laboratory parameters will be assessed and included in an electronic database. Further, interventional data of TIPS implantation will be included in the database.
Apart from these data, patients will be asked to participate in biobank sampling including serum/plasma and peripheral blood mononuclear cells (PBMC) samples from the peripheral veins and from the liver and portal vein that will be taken during TIPS implantation.
All patients recruited in this registry will be followed-up for at least 12 months with regular visits 3, 6 and 12 months after TIPS implantation.
Outcome parameters including development of post-TIPS hepatic encephalopathy, acute- on chronic liver failure (ACLF), infections, recurrence of clinically significant portal hypertension, need for TIPS revision and death and liver transplantation will be assessed.
Вмешательства
- Устройство Implantation of a transjugular intrahepatic portosystemic shunt (TIPS)
For TIPS implantation, a transjugular approach is used in all patients and a puncture needle was advanced into a hepatic vein. Puncture of the portal vein is performed using ultrasound guidance followed by portography after successful puncture of the portal vein. Further, the parenchymal tract isdilated and the stent graft is placed. Before and after TIPS implantation, portal venous and central venous pressures are measured to calculate the porto-systemic pressure gradient
Первичные конечные точки
- Transplantation-free survival [Срок оценки: 01/01/2023-31/12/2033]
Вторичные конечные точки (9)
- Time to development of post-TIPS hepatic encephalopathy [Срок оценки: 01/01/2023-31/12/2033]
- Time to development of post-TIPS acute- on chronic liver failure (ACLF) [Срок оценки: 01/01/2023-31/12/2033]
- Time to need for TIPS revision [Срок оценки: 01/01/2023-31/12/2033]
- Prevalence of osteoporosis in patients with TIPS implantation [Срок оценки: 01/01/2023-31/12/2033]
- Impact of osteoporosis on prognosis and decompensating events after TIPS [Срок оценки: 01/01/2023-31/12/2033]
- Prevalence of sarcopenia in patients with TIPS implantation [Срок оценки: 01/01/2023-31/12/2033]
- Impact of sarcopenia on prognosis and decompensating events after TIPS [Срок оценки: 01/01/2023-31/12/2033]
- Time to development of post-TIPS infections/sepsis [Срок оценки: 01/01/2023-31/12/2033]
- Periinterventional complications [Срок оценки: 01/01/2023-31/12/2033]
Критерии участия
Критерии включения
- Patients allocated to TIPS implantation due to clinically significant cirrhotic and non-cirrhotic portal hypertension
Критерии исключения
- Withdrawal of written 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
Германия · 1 центр
- University Medical Center Freiburg, Department of Medicine II — Freiburg im Breisgau
Публикации
- Heger LA, Chang J, Rohrer C, Reincke M, Eyth A, Sturm L, Schultheiss M, Maier A, Meyer C, Jansen C, Graf K, Ozturk C, Schneider F, Trebicka J, Westermann D, Thimme R, Grundmann S, Praktiknjo M, Bettinger D. Right Ventricular Contractility Predicts Clearance of Ascites After Transjugular Intrahepatic Portosystemic Shunt. Liver Int. 2025 Dec;45(12):e70422. doi: 10.1111/liv.70422. PMID 41204773
Идентификаторы
NCT: NCT05782556 · FRETIR01