Study protocol: HepaT1ca - an observational clinical cohort study to quantify liver health in surgical candidates for liver malignancies.

BACKGROUND: Accurate assessment of liver health prior to undertaking resectional liver surgery or chemoembolisation for primary and secondary cancers is essential for patient safety and optimal outcomes. LiverMultiScan™, an MRI-based technology, non-invasively quantifies hepatic fibroinflammatory disease, steatosis and iron content. We hypothesise that LiverMultiScan™can quantify liver health prior to surgery and inform the risk assessment for patients considering liver surgery or chemoembolization and seek to evaluate this technology in an operational environment. METHODS/DESIGN: HepaT1ca is an observational cohort study in two tertiary-referral liver surgery centres in the United Kingdom. The primary outcome is correlation between the pre-operative liver health assessment score (Hepatica score - calculated by weighting future remnant liver volume by liver inflammation and fibrosis (LIF) score) and the post-operative liver function composite integer-based risk (Hyder-Pawlik) score. With ethical approval and fully-informed consent, individuals considering liver surgery for primary or secondary cancer will undergo clinical assessment, blood sampling, and LiverMultiScan™multiparametric MRI before and after surgical liver resection or TACE. In nested cohorts of individuals undergoing chemotherapy prior to surgery, or those undergoing portal vein embolization (PVE) as an adjunct to surgery, an additional testing session prior to commencement of treatment will occur. Tissue will be examined histologically and by immunohistochemistry. Pre-operative liver health assessment scores and the post-operative risk scores will be correlated to define the ability of LiverMultiScan™to predict the risk of post-operative morbidity and mortality. Because technology performance in this setting is unknown, a pragmatic sample size will be used. For the primary outcome, n = 200 for the main cohort will allow detection of a minimum correlation coefficient of 0.2 with 5% significance and power of 80%. DISCUSSION: This study will refine the technology and clinical application of multiparametric MRI (including LiverMultiScan™), to quantify pre-existing liver health and predict post-intervention outcomes following liver resection. If successful, this study will advance the technology and support the use of multiparametric MRI as part of an enhanced pre-operative assessment to improve patient safety and to personalise operative risk assessment of liver surgery/non-surgical intervention. TRIAL REGISTRATION: This study is registered on ClinicalTrials.gov Identifier: NCT03213314 .

Safety and Hemostatic Effectiveness of the Fibrin Pad for Severe Soft-Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic (Non-cardiac) Surgery: A Randomized, Controlled, Superiority Trial.

BACKGROUND: In surgery, rapid hemostasis can be required in various settings and bleeding intensities to minimize complications related to blood loss. While effective hemostats are available for mild-to-moderate surgical bleeding, few are effective against challenging severe hemorrhage. We report the effectiveness and safety of the fibrin pad (FP), a novel combination hemostat (device/human biologic), in controlling severe soft-tissue bleeding as compared to the standard of care (SoC). METHODS: This randomized, controlled, superiority study enrolled subjects ≥18 years, requiring elective abdominal, retroperitoneal, pelvic, or thoracic (non-cardiac) surgery. A severe target bleeding site (TBS) was identified intra-operatively following which, subjects were randomized to the FP or the SoC group. Hemostatic status was observed at 4 min (primary endpoint) and 10 min post-randomization. Safety variables included TBS-related bleeding and thrombotic events. RESULTS: At 4 min post-randomization, 50/59 (84.7 %) subjects in the FP group and 10/32 (31.3%) [Corrected] subjects in the SoC group achieved hemostasis without needing re-treatment (P < 0.0001). Compared to the SoC group, the FP group showed better hemostasis at 10 min post-randomization [58/59 (98.3 %) vs. 28/32 (87.5 %); P = 0.01], lower mean time to hemostasis (6.1 ± 13.5 vs. 17.8 ± 32.0 min), and a less frequent need for re-treatment (5.1 vs. 53.1 %). The triangular test for binary response demonstrated the FP to be superior to SoC (95 % CI 1.474-3.290; P < 0.0001). Safety profiles in both groups were similar to those typically observed after long-duration surgery. CONCLUSION: The FP is safe and superior to SoC for controlling challenging severe soft-tissue bleeding encountered during intra-abdominal and thoracic surgical procedures.

Management of biliary tract complications after orthotopic liver transplantation.

INTRODUCTION: Despite improved survival, biliary complications remain a significant cause of morbidity following orthotopic liver transplantation. The aim of this study was to review the incidence, treatment and optimum management pathway of biliary complications at the Scottish Liver Transplant Unit. MATERIALS AND METHODS: All patient data were collected prospectively onto a database at the Scottish Liver Transplant Unit with review of hospital records for validation. RESULTS: A total of 379 consecutive orthotopic liver transplants were performed in 333 adult patients between November 1992 and September 2001. Biliary complications occurred in 55 grafts (51 patients) (14.6%) and their incidence decreased with time. Biliary complications occurred in 29 (10.9%) of the 265 choledocho-choledochostomies compared with 14 (25%) of the 56 with T-tubes. Twenty-eight biliary leaks occurred, 22 of which were anastomotic. Seventeen anastomotic leaks were successfully treated non-operatively. Eight patients with biliary leaks subsequently developed an anastomotic stricture. Of the 30 anastomotic strictures, stent insertion was successful in resolving six of 14 (42%) early anastomotic strictures compared with one of 12 (8%) late anastomotic strictures (p = 0.0479). Six (38%) of the 16 early anastomotic strictures required surgery for complete resolution, compared with 12 (86%) of the 14 late anastomotic strictures (p = 0.0106). CONCLUSION: The incidence of biliary complications has decreased with time. The abandonment of choledocho-choledochostomy over a T-tube has been justified. A combination of conservative, endoscopic, and radiological management has been effective in treating biliary leaks and early anastomotic stricture. However endoscopic or radiological stenting was ineffective in the management of late anastomotic strictures, which were best treated by surgical intervention.