Endosonographic Shear Wave Elastography to Assess Liver and Splenic Fibrosis

Официальное название

Endosonographic Shear Wave Elastography to Assess Liver Fibrosis

Обзор

The study is being done to collect information on the effectiveness of endosonographic elastography (a technique which uses sound waves) to measure the stiffness of the liver and spleen. Investigators are trying to determine if shear wave elastography is a good way to measure fibrosis instead of biopsy.

Подробное описание

Study design This is a single-center, prospective, non-randomized, comparative study which will compare the diagnostic accuracy of Endoscopic ultrasound guided shear wave elastography (EUS-SWE) with liver biopsy for liver fibrosis.

Patients who will undergo a standard-of-care EUS guided liver biopsy (or have clinically obvious liver cirrhosis) will be prospectively enrolled after obtaining informed consent. All enrolled patients will undergo EUS guided liver biopsy, unless they have an obvious diagnosis of cirrhosis. EUS-SWE of the liver and spleen.

In selected patients who have been referred for EUS PPG measurement in addition to EUS liver biopsy, portal pressures will be measured as well and correlated with elastography of the spleen.

The patients will be initially assessed for need for liver biopsy by the gastroenterology/hepatology team as per the current standard of care. Only patients with a clear clinical indication for liver biopsy will be enrolled for the study.

Per current standard of practice at Providence Sacred Heart Medical Center, patients who need liver biopsy are referred to the interventional GI service for the procedure. These patients will be offered participation in the trial prior the endoscopic procedure. This detailed discussion will include participation in the study, background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up.

Вмешательства

• Процедура Endosonographic Elastography
  The patient will undergo a standard-of-care endoscopic ultrasound with liver biopsy. At the time, elastography of the liver and spleen will be performed while using the echoendoscope. Different degrees of pressure will be applied while performing elastography of the left and right lobes of the liver as well as the spleen. The E values and VsN values will be recorded and then compared to liver histology.
• Диагностический тест Endosonographic shear wave elastography
  The patient will undergo an upper endoscopic ultrasound procedure. During this procedure, the patient will be put to sleep and a trained endosonographer physician will insert an echo-endoscope through the mouth and guide it down to the stomach and the duodenum. This endoscope is equipped with technology that uses sound waves to assess the stiffness of the liver and spleen. For research purposes, the doctor will also press on these organs in order to take the additional measurements.

Первичные конечные точки

• Degree of fibrosis [Срок оценки: Enrollment to 4 weeks]

Вторичные конечные точки (2)

• Comparative lobar pressure [Срок оценки: Enrollment to 4 weeks]
• Spleen elasticity [Срок оценки: Enrollment to 4 weeks]

Критерии участия

Критерии включения

• Age > 18 years (irrespective of sex)
• Patients determined clinically to have liver cirrhosis needing EUS for other reasons
• Patients determined clinically to be candidates for EUS guided liver biopsy
• Elevated liver enzymes without obvious etiology
• Clinical concern for cirrhosis requiring histological confirmation
• Patients with known cirrhosis without diagnostic dilemma
• Ability to provide informed consent and willing to participate

Критерии исключения

• Surgically altered foregut anatomy which precludes safe endoscopic liver biopsy
• Coagulopathy with INR greater than 1.6 in patients on anticoagulant therapy
• Thrombocytopenia with platelet count less than 50,000/mL
• Pregnancy (positive urine pregnancy test in females of childbearing age)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

США · 1 центр

• Providence Sacred Heart Medical Center — Spokane

Публикации

• Kohli DR, Mettman D, Andraws N, Haer E, Porter J, Ulusurac O, Ullery S, Desai M, Siddiqui MS, Sharma P. Comparative accuracy of endosonographic shear wave elastography and transcutaneous liver stiffness measurement: a pilot study. Gastrointest Endosc. 2023 Jan;97(1):35-41.e1. doi: 10.1016/j.gie.2022.08.035. Epub 2022 Aug 29. PMID 36049537

Идентификаторы

NCT: NCT06867731 · 2024000651

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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