Complications of Cirrhosis
A liver biopsy can provide useful information regarding diagnosis and management of CLD, including in patients with suspected cirrhosis; therefore, the overall safety and complication rates in patients with advanced liver disease were evaluated using the Hepatitis C Antiviral Long-Term Treatment against Cirrhosis (HALT-C) trial. Serial liver biopsies were obtained from each patient at baseline, 18 and 42 months later from 10 separate study sites in those with advanced liver disease (i.e. bridging fibrosis or cirrhosis) with compensated hepatitis C. A total of 2740 liver biopsies were performed (1187 at baseline, 852 at 18 months, and 701 at 42 months after randomization) using a single pass technique in 40% of the cases, whereas two or more passes were made in the remaining 60% in order to attempt to obtain at least 1.5cm of unfragmented liver tissue. All three biopsies were accomplished in 523 (38%) patients; 309 (22%) had two biopsies and 553 (40%) had only one biopsy performed. One of the reasons for missed biopsies that might have influenced the observed complication rate was withholding the procedure due to thrombocytopenia (range 26 000–73 000 mm). The most common reasons for missed biopsies included outcomes reached and patient withdrawal. All participants discontinued aspirin 7–14 days prior to the procedure, and nonsteroidal anti-inflammatory drugs were stopped 1–10 days before the biopsy. The total complication rate for liver biopsies in this large cohort was 2.3% (63/2740), of which 54% (34/63) were classified as nonserious adverse events, whereas 46% (29/63) were categorized as serious adverse events (SAEs). Ninety-four percent of nonserious adverse events were due to transient pain at the biopsy site, with the remaining two patients experiencing a localized hematoma at the biopsy site or inflammation at the intravenous cannula site. The overall frequency of SAEs was 1.1% (29/2740), of which bleeding accounted for 55% (16/29), severe pain seen in 24% (7/29), a punctured gallbladder in 7% (2/29), and hypotension, pneumothorax, syncope and presumed dehydration occurred in one patient each or 3%. No deaths occurred overall as a result of the biopsy. Significant associations with bleeding and SAEs include: a lower albumin level (median level for all SAE patients, 3.7 vs. 3.9 g/l for non-SAE patients; P<0.02); platelet count 60 000mm or less (P<0.0001); International normalized ratio (INR) of at least 1.3 (P<0.01), and the presence of any esophageal varices seen on endoscopy restricted to the second and third biopsies (P<0.004). There was no correlation with bleeding SAEs observed regarding the person who performed the biopsy or the number of passes made. Overall, these data suggest that percutaneous liver biopsies can be safely performed in patients with advanced liver disease, with an acceptable complication rate. Care should be taken in patients with a platelet count 60 000 mm or less or INR of at least 1.3.
Liver Biopsy
A liver biopsy can provide useful information regarding diagnosis and management of CLD, including in patients with suspected cirrhosis; therefore, the overall safety and complication rates in patients with advanced liver disease were evaluated using the Hepatitis C Antiviral Long-Term Treatment against Cirrhosis (HALT-C) trial. Serial liver biopsies were obtained from each patient at baseline, 18 and 42 months later from 10 separate study sites in those with advanced liver disease (i.e. bridging fibrosis or cirrhosis) with compensated hepatitis C. A total of 2740 liver biopsies were performed (1187 at baseline, 852 at 18 months, and 701 at 42 months after randomization) using a single pass technique in 40% of the cases, whereas two or more passes were made in the remaining 60% in order to attempt to obtain at least 1.5cm of unfragmented liver tissue. All three biopsies were accomplished in 523 (38%) patients; 309 (22%) had two biopsies and 553 (40%) had only one biopsy performed. One of the reasons for missed biopsies that might have influenced the observed complication rate was withholding the procedure due to thrombocytopenia (range 26 000–73 000 mm). The most common reasons for missed biopsies included outcomes reached and patient withdrawal. All participants discontinued aspirin 7–14 days prior to the procedure, and nonsteroidal anti-inflammatory drugs were stopped 1–10 days before the biopsy. The total complication rate for liver biopsies in this large cohort was 2.3% (63/2740), of which 54% (34/63) were classified as nonserious adverse events, whereas 46% (29/63) were categorized as serious adverse events (SAEs). Ninety-four percent of nonserious adverse events were due to transient pain at the biopsy site, with the remaining two patients experiencing a localized hematoma at the biopsy site or inflammation at the intravenous cannula site. The overall frequency of SAEs was 1.1% (29/2740), of which bleeding accounted for 55% (16/29), severe pain seen in 24% (7/29), a punctured gallbladder in 7% (2/29), and hypotension, pneumothorax, syncope and presumed dehydration occurred in one patient each or 3%. No deaths occurred overall as a result of the biopsy. Significant associations with bleeding and SAEs include: a lower albumin level (median level for all SAE patients, 3.7 vs. 3.9 g/l for non-SAE patients; P<0.02); platelet count 60 000mm or less (P<0.0001); International normalized ratio (INR) of at least 1.3 (P<0.01), and the presence of any esophageal varices seen on endoscopy restricted to the second and third biopsies (P<0.004). There was no correlation with bleeding SAEs observed regarding the person who performed the biopsy or the number of passes made. Overall, these data suggest that percutaneous liver biopsies can be safely performed in patients with advanced liver disease, with an acceptable complication rate. Care should be taken in patients with a platelet count 60 000 mm or less or INR of at least 1.3.
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