15- Clinical evidences of Glubran®2 biliostatic properties

In the last decades, thanks to the improvements of neoadjuvant chemotherapy and to the availability of biological drugs (molecular targeted), the indications in surgical treatment of primary and secondary hepatic cancers, have greatly expanded. Significant, in this sense, are the results of the OBELIX study (1), which confirm the efficacy in metastatic, or locally advanced, colorectal cancer, in combination with bevacizumab / oxaliplatin / capecitabine, not only in terms of disease-free survival, but also as “downsizing” that can increase the rate of secondary resection, potentially curative of liver metastases (RO resection, with tumorfree margins).
Therefore, resection surgery is now offered at a growing number of patients: in other words, the limits of resectability/operability (related to the number and volume of lesions, hilar lymph nodes status, etc.) are going to be redefined, and oncologic hepatic surgery has become, so to speak, increasingly bold.
Currently, the hepatic tumour is considered resectable if it is technically possible to completely remove it, by saving, at least, two contiguous liver segments (and its biliary drainage), for a residual volume but not less than 30% or 40%, if coexisting neoplastic disease (cirrhosis, steatohepatitis, or other liver damage from chemotherapy).
The more “aggressive” surgery, even in the treatment of advanced and / or multiple lesions, has in fact resulted, despite technology improvements (staplers, evolved solutions for haemostasis control, etc.), an increase of complications post liver resection (2-10).In particular, bile leakage, that do not close spontaneously, and which can then hesitate in the creation of a so-called biloma (ie. an encapsulated collection of bile, outside the biliary tree) (Figure 1) or, even worse, in the biliary fistula.
In literature, the incidence of bilomas turns out to be 4-17%, up to 42% in some case studies, with their showing even 10 to 15 days after surgery (11-13).
The borderline resectable patients, undergoing neoadjuvant chemotherapy, are particularly at risk . Available evidence and personal experience (14) show that, compared with patients without biliary fistula, those with post-operative biloma have a higher risk of more severe complications (54.3 vs. 29.2%, P = 0.002), and extended hospitalization (29 days vs 14 days, P <0.001), with a significant ncrease of mortality ……………………………………………….Read more