6533b86dfe1ef96bd12ca841
RESEARCH PRODUCT
Randomized clinical trial comparing liver resection with and without perioperative assessment of liver function
M JaraR. FahrnerMaciej MalinowskiMaciej MalinowskiJ. MittlerJohan F. LockFlorian W. R. VondranH.-m. TautenhahnIngo KleinH. BektasMartin Stockmannsubject
medicine.medical_specialtymedicine.diagnostic_testSurrogate endpointbusiness.industryIncidence (epidemiology)General MedicinePerioperative030230 surgeryIntensive care unitlaw.inventionSurgery03 medical and health sciences0302 clinical medicineRandomized controlled triallaw030220 oncology & carcinogenesisClinical endpointmedicineLiver functionLiver function testsbusinessdescription
Background Liver function tests may help to predict outcomes after liver surgery. The aim of this study was to evaluate the clinical impact on postoperative outcome and patient management of perioperative liver function testing using the LiMAx® test. Methods A multicentre RCT was conducted in six academic liver centres. Patients with intrahepatic tumours scheduled for open liver resection of at least one segment were eligible. Patients were randomized to undergo additional perioperative liver function tests (LiMAx® group) or standard care (control group). Patients in the intervention arm received two perioperative LiMAx® tests, one before the operation for surgical planning and another after surgery for postoperative management. The primary endpoint was the proportion of patients transferred directly to a general ward. Secondary endpoints were severe complications, length of hospital stay (LOS) and length of intermediate care/ICU (LOI) stay. Results Some 148 patients were randomized. Thirty-six of 58 patients (62 per cent) in the LiMAx® group were transferred directly to a general ward, compared with one of 60 (2 per cent) in the control group (P < 0·001). The rate of severe complications was significantly lower in the LiMAx® group (14 per cent versus 28 per cent in the control group; P = 0·022). LOS and LOI were significantly shorter in the LiMAx® group (LOS: 10·6 versus 13·3 days respectively, P = 0·012; LOI: 0·8 versus 3·0 days, P < 0·001). Conclusion Perioperative use of the LiMAx® test improves postoperative management and reduces the incidence of severe complications after liver surgery. Registration number: NCT01785082 ( https://clinicaltrials.gov).
year | journal | country | edition | language |
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2018-06-14 | BJS Open |