ABSTRACT
Importance: Tranexamic acid reduces bleeding and blood transfusion in many types of surgery, but its effect in patients undergoing liver resection for a cancer-related indication remains unclear. Objective: To determine whether tranexamic acid reduces red blood cell transfusion within 7 days of liver resection. Design, Setting, and Participants: Multicenter randomized clinical trial of tranexamic acid vs placebo conducted from December 1, 2014, to November 8, 2022, at 10 hepatopancreaticobiliary sites in Canada and 1 site in the United States, with 90-day follow-up. Participants, clinicians, and data collectors were blinded to allocation. A volunteer sample of 1384 patients undergoing liver resection for a cancer-related indication met eligibility criteria and consented to randomization. Interventions: Tranexamic acid (1-g bolus followed by 1-g infusion over 8 hours; n = 619) or matching placebo (n = 626) beginning at induction of anesthesia. Main Outcomes and Measures: The primary outcome was receipt of red blood cell transfusion within 7 days of surgery. Results: The primary analysis included 1245 participants (mean age, 63.2 years; 39.8% female; 56.1% with a diagnosis of colorectal liver metastases). Perioperative characteristics were similar between groups. Red blood cell transfusion occurred in 16.3% of participants (n = 101) in the tranexamic acid group and 14.5% (n = 91) in the placebo group (odds ratio, 1.15 [95% CI, 0.84-1.56]; P = .38; absolute difference, 2% [95% CI, -2% to 6%]). Measured intraoperative blood loss (tranexamic acid, 817.3 mL; placebo, 836.7 mL; P = .75) and total estimated blood loss over 7 days (tranexamic acid, 1504.0 mL; placebo, 1551.2 mL; P = .38) were similar between groups. Participants receiving tranexamic acid experienced significantly more complications compared with placebo (odds ratio, 1.28 [95% CI, 1.02-1.60]; P = .03), with no significant difference in venous thromboembolism (odds ratio, 1.68 [95% CI, 0.95-3.07]; P = .08). Conclusions and Relevance: Among patients undergoing liver resection for a cancer-related indication, tranexamic acid did not reduce bleeding or blood transfusion but increased perioperative complications. Trial Registration: ClinicalTrials.gov Identifier: NCT02261415.
ABSTRACT
BACKGROUND: Previous studies report promising outcomes with minimally invasive (MIS) hepatectomy in elderly patients but remain limited by small size. This study aims to comparatively evaluate the demographics and outcomes of geriatric patients undergoing MIS and open hepatectomy. METHOD: The 2016-2021 NSQIP database was evaluated comparing patients ≥75 undergoing MIS versus open hepatectomy. Patient selection and outcomes were compared using bivariate analysis with multivariable modeling (MVR) evaluating factors associated with serious complications and mortality. Propensity score matched (PSM) analysis further evaluated serious complications, mortality, length of stay (LOS), Clavien Dindo Classification (CDC), and Comprehensive Complication Index (CCI) for cohorts. RESULTS: We evaluated 2674 patients with 681 (25.5%) receiving MIS hepatectomy. MIS approaches were used more for partial lobectomy (85.9% vs. 61.7%; p < 0.001), and required fewer biliary reconstructions (1.6% vs. 10.6%; p < 0.001). Patients were similar with regards to sex, body mass index, and other comorbidities. Unadjusted analysis demonstrated that MIS approaches had fewer serious complications (8.8% vs. 18.7%; p < 0.001). However, after controlling for cohort differences the MIS approach was not associated with reduced likelihood of serious complications (odds ratio [OR]: 0.77; p = 0.219) or mortality (OR: 1.19; p = 0.623). PSM analysis further supported no difference in serious complications (p = 0.403) or mortality (p = 0.446). However, following PSM a significant reduction in LOS (-1.99 days; p < 0.001), CDC (-0.26 points; p = 0.016) and CCI (-2.79 points; p = 0.022) was demonstrated with MIS approaches. CONCLUSIONS: This is the largest study comparing MIS and open hepatectomy in elderly patients. Results temper previously reported outcomes but support reduced LOS and complications with MIS approaches.
ABSTRACT
Backgrounds/Aims: While patients with borderline resectable pancreatic cancer (BRPC) are a target population for neoadjuvant chemotherapy (NAC), formal guidelines for neoadjuvant therapy are lacking. We assessed the perioperative and oncological outcomes in patients with BRPC undergoing NAC with FOLFIRINOX for patients undergoing upfront surgery (US). Methods: The AHPBA criteria for borderline resectability and/or a CA19-9 level > 100 µ/mL defined borderline resectable tumors retrieved from a prospectively populated institutional registry from 2007 to 2020. The primary outcome was overall survival (OS) at 1 and 3 years. A Cox Proportional Hazard model based on intention to treat was used. A receiver-operator characteristics (ROC) curve was constructed to assess the discriminatory capability of the use of CA19-9 > 100 µ/mL to predict resectability and mortality. Results: Forty BRPC patients underwent NAC, while 46 underwent US. The median OS with NAC was 19.8 months (interquartile range [IQR], 10.3-44.24) vs. 10.6 months (IQR, 6.37-17.6) with US. At 1 year, 70% of the NAC group and 41.3% of the US group survived (p = 0.008). At 3 years, 42.5 % of the NAC group and 10.9% of the US group survived (p = 0.001). NAC significantly reduced the hazard of death (adjusted hazard ratio, 0.20; 95% confidence interval, 0.07-0.54; p = 0.001). CA19-9 > 100 µ/mL showed poor discrimination in predicting mortality, but was a moderate predictor of resectability. Conclusions: We found a survival benefit of NAC with FOLFIRINOX for BRPC. Greater pre-treatment of CA19-9 and multivessel involvement on initial imaging were associated with progression of the disease following NAC.