Меню
Идёт набор NCT05699018

Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients

Без фазы С лечением Non-alcoholic Fatty Liver Disease (NAFLD) Alcoholic Liver Disease (ALD) Liver Fibrosis

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: eLIFT.
Кому может быть актуально
Состояния в реестре: Non-alcoholic Fatty Liver Disease (NAFLD), Alcoholic Liver Disease (ALD), Liver Fibrosis. Базовые параметры: 40 лет — 80 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The primary objective of the SOPRANO study is to compare two blood fibrosis tests, the eLIFT and the FibroMeter, for the screening of advanced liver fibrosis in patients with NAFLD and/or ALD from primary care centers.

Подробное описание

Chronic liver diseases (CLD) are responsible for 17 000 deaths each year in France (cirrhosis: 8 000, liver cancer: 9 000). Non-alcoholic fatty liver disease (NAFLD) and alcoholic liver disease (ALD) are the two main causes of CLD in France, affecting respectively 25% and 12% of the adult general population. A subset of these patients develops advanced liver fibrosis (ALF), which requires referral to the specialist for specific evaluation and management to avoid the occurrence of cirrhosis and its life-threatening complications. General practitioners (GPs) are the first-line physicians in front of the large population of NAFLD and/or ALD patients. It is very difficult for GPs to identify the patients who develop ALF and require referral to the specialist, as their physical examination, usual biology and ultrasonography remain normal.

The non-invasive diagnosis of liver fibrosis is now available with elastography devices and blood tests. Elastography is a very accurate method but it is available only in few specialised centers. Specialised blood tests are available to all physicians, but they are quite expensive and not reimbursed with therefore limited use in clinical practice. Consequently, liver fibrosis remains unevaluated in most patients with NAFLD and/or ALD, which explains why a lot are too late diagnosed at the stage of cirrhosis complications with poor short-term survival.

The eLIFT isa new blood fibrosis test specifically dedicated for GPs with simple parameters and easy "by head" calculation. The simple eLIFT was compared with the specialised blood test FibroMeter for the diagnosis of ALF in an cohort of 1024 biopsy-proven NAFLD and/or ALD patients. eLIFT was little less accurate than FibroMeter (AUROC: 0.78 vs 0.81). Using the recommended cut-offs (eLIFT ≥8, FibroMeter ≥0.46), eLIFT was more sensitive than FibroMeter (86% vs 77%), whereas FibroMeter was highly more specific (71% vs 51%). These results position eLIFT and FibroMeter as interesting tools for the screening of ALF in large populations.

As the preliminary results come from very selected patients, i.e. patients from tertiary centers who underwent a liver biopsy, it's necessary nox to evaluate in the real condition of primary care setting whether the use of eLIFT or FibroMeter will help GPs to screen ALF in their asymptomatic NAFLD and ALD patients.

Вмешательства

  • Диагностический тест eLIFT
    Diagnostic procedure: elastography devices, blood tests (e-LIFT + Fibrometer), liver biopsy if necessary (elastometry ≥ 8 kPa and \< 15 kPa)

Первичные конечные точки

  • Sensitivity of the eLIFT test for advanced liver fibrosis [Срок оценки: 1 day]
  • Sensitivity of the Fibrometer test for advanced liver fibrosis [Срок оценки: 1 day]
Вторичные конечные точки (12)
  • rate of patients referred to the specialist following the screening procedure, with eLIFT test [Срок оценки: 1 day]
  • rate of patients referred to the specialist following the screening procedure, with FibroMeter test [Срок оценки: 1 day]
  • Rate of "unnecessary referrals" to the specialist with eLIFT test [Срок оценки: 1 month]
  • Rate of "unnecessary referrals" to the specialist with Fibrometer test [Срок оценки: 1 month]
  • Number of hepatocellular carcinoma adetected following the screening procedure, with comparison between eLIFT and FibroMeter strategies [Срок оценки: 1 month]
  • Number of gastroesophageal varices at risk of bleeding detected following the screening procedure, with comparison between eLIFT and FibroMeter strategies [Срок оценки: 1 month]
  • directs costs by type of disease such as ALF, hepatocellular carcinoma, gastroesophageal varices at risk of bleeding with comparison between eLIFT and FibroMeter strategies [Срок оценки: 1 month]
  • eLIFT and FibroMeter screening procedures as a function of the cause of the underlying liver disease (NAFLD, ALD, or mixed NAFLD+ALD) [Срок оценки: 1 month]
  • the accuracy of a sequential strategy using eLIFT as first-line test and FibroMeter as second-line test [Срок оценки: 1 day]
  • patient adherence to the screening of advanced liver fibrosis [Срок оценки: 1 month]
  • most relevant risk factor of advanced liver fibrosis in patients with NAFLD and/or ALD from primary care [Срок оценки: 1 day]
  • specialized blood test ELF for the screening of advanced liver fibrosis in patients with NAFLD and/or ALD from primary care centers [Срок оценки: 1 day]

Критерии участия

Критерии включения

  • NAFLD and/or ALD patient defined by at least 1 of the following criteria:
  • Excessive alcohol consumption: higher than 210 g / week (men), or 140 g / week (women)
  • Type 2 diabetes
  • at least 2 metabolic factors among BMI higher than or equal to 25 kg / m 2; Elevated blood pressure (antihypertensive drug, or systolic blood pressure higher than or equal to 130mmHg, or diastolic blood pressure higher than or equal to 85mmHg), Dyslipidemia (lipid-lowering drug, or HDL cholesterol lower to 40mg/dl (men) / 50mg/dl (women), or triglycerides higher than or equal to150mg/dl); Hyperferritinemia (higher than upper limit of normal from the laboratory)
  • Bright liver at ultrasonography without steatosis-inducing drug(systemic corticosteroids, tamoxifen, amiodarone, methotrexate)

Following a protocol amendment, the 3 last investigating primary care centres will include NAFLD and/or ALD patients according to these updated criteria:

  • Excessive alcohol consumption: >210 g/week in men or >140 g/week in women,
  • AND/OR type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments,
  • AND with the following stratification:

30% with excessive alcohol consumption 65% with type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments 5% with both conditions (excessive alcohol consumption, AND type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments)

  • Patient's agreement to have a blood sample collected in a local laboratory participating in the study
  • Subjects covered by or having the rights to medical care assurance
  • Written informed consent obtained from subject

Критерии исключения

  • Already ongoing specialized follow-up for a chronic liver disease
  • Altered health status with poor short-term prognosis, not compatible with a screening procedure
  • Decompensated cirrhosis (hepatic encephalopathy, jaundice, ascites, variceal bleeding, hepatorenal syndrome)
  • Acute infection
  • Pregnancy, breastfeeding
  • Persons in detention by judicial or administrative decision
  • Person admitted to a health or social establishment for purposes other than research
  • Person subject to a legal protection measure
  • Person unable to express consent

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
Скрининг

Центры проведения

Франция · 13 центров
  • ANGERS — Angers
  • CHU Angers — Angers
  • BAUGE — Baugé-en-Anjou
  • BECON — Bécon-les-Granits
  • Chalonnes — Chalonnes-sur-Loire
  • COMBOURG — Combourg
  • LIFFRE — Liffré
  • Montreuil — Montreuil-Bellay
  • … и ещё 5 центров

Идентификаторы

NCT: NCT05699018 · 2022-A02148-35

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗