METHODS
This observational, retrospective, and single-center study involved individuals submitted to outpatient PLB from January 2015 to December 2019 at the Gastrocentro of the University of Campinas (Unicamp), Campinas, Brazil. Patients were eligible according to a database record and subsequently, analysis of manual and electronic medical records was conducted. The protocol was analyzed and approved by the Ethics Committee of the University of Campinas (Unicamp) (CAAE: 29553819.9.0000.5404). An informed consent term was applied to the patients who were still on follow-up at our center.
Inclusion criteria: patients > 12 years old submitted to US-guided PLB at the Gastrocentro (Unicamp) during the study period. Exclusion criteria: those with incomplete data in the medical records. We analyzed gender, age, comorbidities, platelets count, INR (international normalized ratio), indication for the biopsy, number of needle passes, as well as PLB-related AEs and outcomes. Patients submitted to more than one PLB were considered as a new case.
The indications for PLB were classified as follows: HCV, hepatitis B virus (HBV), autoimmune hepatitis (AIH) / cholestasis, elevated liver enzymes, metabolic dysfunction-associated fatty liver disease (MAFLD), and post-transplant follow-up. Other indications, such as suspicion of drug-induced liver injury, were adjudicated as elevated liver enzymes.
The patients“ comorbidities were classified as 1) cardiovascular : high blood pressure, diabetes mellitus, dyslipidemia, heart failure; 2)overweight or obesity , 3) chronic kidney disease , 4)neuropsychiatric disorders , 5) other : thyroid, respiratory, intestinal disorders or acquired human immunodeficiency syndrome, as described in the medical records. Patients could be inserted into more than one group of comorbidities.
All the procedures were performed in a real-time US-guided setting and the operator was a senior resident supervised by a hepatologist. Patients were instructed to fast for 6 hours and to withdraw anticoagulants and anti-inflammatory drugs for at least one week before the biopsy. Insulin and oral antidiabetics were withdrawn on the day of the procedure. Continuous use medications should not be suspended.
Patients were positioned supine on the bed with his or her right arm placed above the head. A low dose of intravenous midazolam (2 to 3 mg) was usually administered. Local anesthesia was performed with lidocaine 2% after skin sterilization. A Tru-cut 14G needle was used preferably in the right hepatic lobe accessing through intercostal spaces. The number of needle passes depended on the operator“s decision. Patients remained on complete rest and fasting in a comfortable position, under the monitoring of vital signs, and were discharged after 4 to 6 hours. They were instructed to return in case of severe pain in the abdomen, chest or at the puncture site, dizziness, fainting, nausea, vomiting, or dyspnea.
The PLB-related consequences were divided as follows: 1) pain : complained by the patient at the puncture site, on the right shoulder, thorax, or abdomen. 2) mild AEs : high blood pressure (systolic blood pressure > 150mmHg), low blood pressure (systolic blood pressure < 90mmHg), nausea/vomiting, headache, and hypoglycemia (<70 mg/dL on capillary glucometer). 3)serious AEs : detection of perihepatic fluid at bedside US examination, subcapsular bleeding, right-sided hemothorax, and death. The need for hospital admission and surgical treatment was assessed up to two months following the procedure.