Our Summary

This research paper explores the reliability of liver biopsy readings by liver disease specialists (hepatopathologists) in clinical trials for non-alcoholic fatty liver disease (NASH). The researchers evaluated these readings from a clinical trial testing a new treatment for NASH. They found significant variability in the readings between different hepatopathologists. This means that different specialists might interpret the same biopsy in different ways, leading to inconsistencies in patient inclusion in the study, classification of liver scarring (fibrosis), and assessment of the treatment’s effectiveness. This variability can also significantly reduce the reliability of the study’s results. The authors stress the need for a more reliable system for evaluating liver biopsies in clinical trials for NASH.

FAQs

  1. What was the main finding of the research study on liver biopsy readings by hepatopathologists in clinical trials for NASH?
  2. How does variability in liver biopsy readings affect the reliability of clinical trials for NASH?
  3. What did the authors recommend to improve the reliability of liver biopsy evaluations in clinical trials for NASH?

Doctor’s Tip

A doctor might tell a patient undergoing a liver biopsy to ensure they follow all pre-procedure instructions, such as fasting before the procedure, to ensure accurate results. They may also advise the patient to discuss any concerns or questions they have about the procedure with their healthcare provider before undergoing the biopsy. Additionally, they may recommend following up with their healthcare provider for post-procedure care and to discuss the results of the biopsy.

Suitable For

Liver biopsy is typically recommended for patients with suspected liver diseases such as:

  1. Chronic hepatitis B or C: Patients with chronic viral hepatitis may undergo a liver biopsy to assess the extent of liver damage and guide treatment decisions.

  2. Alcoholic liver disease: Patients with a history of heavy alcohol consumption may undergo a liver biopsy to evaluate the extent of liver damage and determine the best treatment approach.

  3. Autoimmune liver diseases: Patients with autoimmune liver diseases such as autoimmune hepatitis or primary biliary cholangitis may undergo a liver biopsy to assess disease severity and guide treatment decisions.

  4. Non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH): Patients with NAFLD or NASH may undergo a liver biopsy to assess the degree of liver inflammation and fibrosis, which can help determine disease progression and guide treatment decisions.

  5. Metabolic liver diseases: Patients with metabolic liver diseases such as hemochromatosis or Wilson’s disease may undergo a liver biopsy to assess the extent of liver damage and guide treatment decisions.

Overall, liver biopsy is recommended for patients with suspected liver diseases where a definitive diagnosis and assessment of liver damage is needed to guide treatment decisions.

Timeline

Before liver biopsy:

  1. Patient consultation: The patient meets with their healthcare provider to discuss the need for a liver biopsy, the risks and benefits, and any alternative options.
  2. Pre-procedure preparation: The patient may need to fast before the procedure and stop taking certain medications.
  3. Consent: The patient gives informed consent for the procedure.
  4. Anesthesia: The patient is given local anesthesia to numb the area where the biopsy will be taken.
  5. Biopsy procedure: A small sample of liver tissue is taken using a needle inserted through the skin.

After liver biopsy:

  1. Recovery: The patient is monitored for a few hours to ensure there are no complications such as bleeding or infection.
  2. Post-procedure care: The patient may be advised to rest for the remainder of the day and avoid strenuous activities.
  3. Follow-up appointment: The patient may need to return for a follow-up appointment to discuss the results of the biopsy.
  4. Biopsy interpretation: The liver tissue sample is analyzed by a hepatopathologist to determine if there are any signs of liver disease such as inflammation, fibrosis, or cirrhosis.
  5. Treatment plan: Based on the biopsy results, the patient’s healthcare provider will develop a treatment plan tailored to their specific liver condition.

What to Ask Your Doctor

  1. What is the purpose of the liver biopsy and what information will it provide about my liver health?
  2. How is the liver biopsy performed and what are the potential risks and complications?
  3. Who will be interpreting the biopsy results and what qualifications do they have?
  4. Are there alternative tests or imaging techniques that can provide similar information without the need for a biopsy?
  5. How will the results of the biopsy be used to guide my treatment plan?
  6. What steps are taken to ensure the accuracy and consistency of the biopsy readings, especially in the context of clinical trials?
  7. Can I request a second opinion or have the biopsy results reviewed by another specialist?
  8. How long will it take to receive the results of the biopsy and how will they be communicated to me?
  9. What follow-up care or monitoring will be needed after the biopsy procedure?
  10. Are there any specific instructions or restrictions I need to follow before or after the biopsy?

Reference

Authors: Davison BA, Harrison SA, Cotter G, Alkhouri N, Sanyal A, Edwards C, Colca JR, Iwashita J, Koch GG, Dittrich HC. Journal: J Hepatol. 2020 Dec;73(6):1322-1332. doi: 10.1016/j.jhep.2020.06.025. Epub 2020 Jun 28. PMID: 32610115