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Идёт набор NCT07607353

Biodegradable Stents in Primary Sclerosing Cholangitis

Без фазы С лечением Primary Sclerosing Cholangitis (PSC)

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: archimedes stent.
Кому может быть актуально
Состояния в реестре: Primary Sclerosing Cholangitis (PSC). Базовые параметры: от 18 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
Великобритания
Следующий шаг
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Официальное название

Pilot Study of Biodegradable STents in Primary Sclerosing Cholangitis - BSTPSC

Обзор

In patients with PSC, endoscopic therapy of strictures aims to improve cholestasis by relieving the biliary obstruction via endoscopic biliary dilatation with consideration of plastic stents in strictures refractory to dilatation due to the risk of pancreatitis and cholangitis . Short term stents have been shown to have similar recurrence-free rates compared to dilatation in a randomised control trial; however, this was terminated after interim analysis due to higher rates of serious adverse events in the stent group. The long term benefits are unclear; however, it may lead to improved survival compared to predicted survival. In this group of patients with limited treatment options, biodegradable stents may provide an attractive additional treatment modality in the management of high grade strictures.

Подробное описание

Research hypothesis

The use of biodegradable stents leads to remodelling of high grade strictures in patients with PSC with fewer interventions in comparison to balloon dilation alone with a comparable risk profile to current therapy.

Primary endpoint

Technical success and safety of biodegradable stent placement at ERC

Secondary endpoints

* Cumulative recurrence -free rate of primary high grade strictures within 12 months * Change in symptoms as assessed by the Amsterdam cholestatic complaints score (ACCS) * Clinical success is defined by improvement in liver function tests (LFT) by 20% at week 2 and week 12. * Improvement in quality fo life as assessed by the Short form-36 (SF-36). * Mortality, morbidity, local complications, stricture recurrence, decompensation of liver disease, liver transplantation over 12 months.

Вмешательства

  • Устройство archimedes stent
    archimedes stent for HGS

Первичные конечные точки

  • Deployment of biodegradable stent placement across stricture at ERC in 20 patients [Срок оценки: at time of primary ERC]
Вторичные конечные точки (9)
  • Cumulative recurrence -free rate of primary high grade strictures within 12 months. [Срок оценки: through study completion up to 12 months]
  • Change in symptoms as assessed by the Amsterdam cholestatic complaints score (ACCS) [Срок оценки: Post ERC to assessment at 2 weeks and 12 weeks, and at 12 months.]
  • Clinical success is defined by improvement in liver function tests (LFT) by 20% at week 2 and week 12. [Срок оценки: At week 2 and 12 weeks post ERCP]
  • Change in quality fo life as assessed by the Short form-36 (SF-36 [Срок оценки: after ERC and assesment at 2 weeks, 12 weeks and 12 months]
  • Mortality over 12 months. [Срок оценки: Within 12 months of primary ERCP]
  • morbidity related to ERC [Срок оценки: within 12 months of ERC]
  • stricture recurrence post ERC [Срок оценки: 12 months post ERC]
  • Development of ascites post erc [Срок оценки: up to 12 months post ERC]
  • Need for liver transplantation [Срок оценки: up to 12 months following ERC]

Критерии участия

Критерии включения

  • PSC patients with a high grade stricture

Критерии исключения

  • Prior stenting or balloon dilatation within the previous 4 months
  • Signs of bacterial cholangitis as defined by definite cholangitis
  • Change of UDCA therapy within 4 weeks
  • Inability to give informed consent
  • Biliary cirrhosis with Child Pugh score > 8
  • Estimated transplant free survival < 2 years as calculated by Mayo score > 2
  • Suspicion of cholangiocarcinoma, reflected by an imaging study suggestive of metastasis, MRCP with mass lesion with contrast enhancenment, or rise in CA19.9 of > 63 U/ml in the previous 4 months together with an absolute value > 130 U/ml
  • Signs of current malignancy other than basal cell carcinoma
  • Life expectancy < 24 months
  • Women pregnant at the time of screening
  • HIV or acute or chronic hepatitis B or hepatitis C or substance (drug or alcohol) misure within the previous 2 years.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Великобритания · 1 центр
  • King's College Hospital, London — London

Идентификаторы

NCT: NCT07607353 · IRAS 336318

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗