Informed Consent for Percutaneous Liver Biopsy

Procedure Name

Form Sections

Section 1info grid

Facility / Clinic Name

Performing Physician

Patient Full Legal Name

Date of Birth

Medical Record Number (MRN)

Date of Procedure

Imaging Guidance Method

Coagulation Lab Status

Section 2text block

Section 3list block

Section 4list block

Section 5text block

Section 6list block

Section 7text block

Section 8text block

Section 9text block

Section 10text block

Section 11text block

Section 12text block

Section 13text block

Section 14signature block

Patient / LAR Signature

Physician Signature

Witness Signature

Date and Time of Consent

Informed Consent for Percutaneous Liver Biopsy

Patient and Procedure Information

Facility / Clinic Name

Performing Physician

Patient Full Legal Name

Date of Birth

Medical Record Number (MRN)

Date of Procedure

Imaging Guidance Method

Coagulation Lab Status

Nature and Purpose of the Procedure

A percutaneous liver biopsy is a procedure to remove a small sample of liver tissue for laboratory examination. It is used to diagnose liver diseases, assess the severity of liver damage (fibrosis or cirrhosis), and monitor the effectiveness of treatments. Under local anesthesia (and sometimes mild IV sedation), the physician uses ultrasound imaging to locate the safest entry point between your ribs on your right side. A small incision is made, and a specialized biopsy needle is quickly inserted into the liver to capture a thin tissue core. You will be asked to hold your breath for 5 to 10 seconds during the needle insertion to keep your liver still and prevent injury. The tissue sample is sent to a pathology lab, and the entry site is covered with a compression dressing.

Coagulation and Blood Thinning Verification

I confirm that I have told my provider about all blood-thinning medications (aspirin, Plavix, Coumadin, Eliquis, Xarelto) and have stopped them for the recommended number of days.

I understand that my blood clotting ability (INR and platelet count) must be checked before the procedure to minimize the risk of internal bleeding.

I agree to have my blood drawn for these tests on the day of or shortly before the procedure.

Material Risks and Potential Complications

Pain: pain at the biopsy site or in the right shoulder (referred pain from the diaphragm) is the most common side effect. It affects about 20 percent of patients. It is usually mild and managed with acetaminophen. NSAIDs such as ibuprofen must be avoided.

Internal bleeding: the liver has a rich blood supply. Severe internal bleeding occurs in less than 1 in 500 cases. It can cause a drop in blood pressure, require a blood transfusion, or in rare cases, require an emergency procedure or surgery to stop the bleeding.

Bile leak: the biopsy needle can puncture a bile duct, causing bile to leak into the abdominal cavity. This causes severe abdominal pain and irritation, requiring close monitoring or a biliary stent.

Pneumothorax: the needle can accidentally puncture the lung lining, causing a collapsed lung. This occurs in less than 1 in 1,000 cases. A chest tube may be needed to re-expand the lung.

Organ puncture: rare accidental puncture of the gallbladder, kidney, or bowel.

Infection: very rare at the insertion site or inside the abdominal cavity.

Post-Procedure Observation and Care

Following the biopsy, you must remain in the recovery area for at least 2 to 4 hours. You will be asked to lie on your right side for the first 1 to 2 hours to apply pressure to the liver and reduce bleeding risks. Your blood pressure, pulse, and pain levels will be checked regularly. For the first 24 hours at home, you must avoid heavy lifting (nothing over 10 pounds), strenuous exercise, and driving. You may resume light activities the next day.

Alternatives to Liver Biopsy

Non-invasive imaging: FibroScan (transient elastography), ultrasound, CT, or MRI can estimate liver stiffness and fat content but cannot detail cell structure or inflammation as accurately as a biopsy.

Blood tests: panels such as FibroSure can estimate liver scarring but may be less reliable in complex or overlapping liver conditions.

No biopsy: monitoring symptoms and repeating blood tests over time, accepting that the exact diagnosis or disease stage remains unconfirmed.

Post-Biopsy Warning Signs

Seek immediate emergency medical care if you experience any of the following after discharge: (1) Severe, sharp, or worsening pain at the biopsy site or in your abdomen, (2) Shortness of breath or chest pain, (3) Dizziness, fainting, or feeling lightheaded, (4) Fever or chills, (5) Bleeding or leakage from the insertion site.

Discharge Driver Requirement

If you receive mild sedation, you must have a responsible adult driver accompany you and drive you home. You are advised not to drive or make critical decisions for 24 hours after the procedure.

Right to Withdraw Consent

You have the right to refuse this procedure. The physician will discuss the implications of not performing the biopsy, which include treating a liver condition without confirmation of its exact type or stage.

Patient Understanding and Questions

I confirm that I have read this document and understand the percutaneous liver biopsy procedure, its risks (including bleeding and lung puncture), and its alternatives. I have had my questions answered to my satisfaction.

Language Access

If English is not your primary language, a qualified interpreter is available at no cost. Please inform staff before signing.

Copy of Consent Acknowledgment

I acknowledge that I have been offered a signed copy of this consent form.

Patient Authorization

I voluntarily consent to undergo a percutaneous liver biopsy under ultrasound or CT guidance as determined by the physician. I confirm I have followed all medication suspension guidelines.

Signatures and Verification

Patient / LAR Signature

Physician Signature

Witness Signature

Date and Time of Consent

Document ID: CC-PENDING

CONSENTCOLLECT