Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures
Liver CancerThis study was designed in two phases: Phase I is designed to confirm that the surgeon is able to perform accurate liver surface registration including standard liver features used as landmarks during a scheduled laparoscopic liver ablation procedure and acquires a level of comfort with the procedure. The surface of the liver will be manually swabbed with the study tracked laparoscopic probe with landmarks noted during data collection. After registration of the liver is obtained, the registration points obtained during this procedure will be evaluated by the surgeon by moving the tracked laparoscopic probe over the liver surface and evaluating the location of the tracked laparoscopic probe displayed on the guidance system three dimensional (3D) image. The surgeon will accept or reject the registration accuracy. The hypothesis is that the surgeon will be able to successfully acquire liver surface registrations with a small learning curve for technique and will be able to proceed to Phase II of the study. Phase II contains the registration process included above but adds the additional process of tracking the ablation probe used to perform tumor ablation by attaching the Pathfinder Multi-Tool adaptor and collecting data showing the location of the ablation probe as tracked and displayed on the Pathfinder three dimensional (3D) image. The surgeon will use ultrasound (US) guidance to locate tumor location during the laparoscopic procedure. The images collected during this process will be recorded by Pathfinder.
Evaluation of Preoperative Investigations in Patients With Liver Cancer
Primary Liver CancerLiver MetastasisThe aim of the study is to evaluate the diagnostic procedures emission tomography in combination with a CT scan (PET/CT) and endoscopic ultrasonography (EUS) in the preoperative evaluation of resectability of patients with primary or secondary liver cancers.
Evaluation of Diffusion Weighted Imaging -MRI in Patients With Resectable Liver Metastases From...
Liver MetastasesColorectal CancerThe primary objective of this study is to correlate the percentage change in apparent diffusion coefficient (ADC) between baseline and early therapy (at day 14) with tumor regression grade (TRG) measured in the surgical resection specimen.
The Effect of Branched-chain Amino Acid (BCAA) on the Progression of Primary Liver Cancer
Primary Liver CancerSupplementation of BCAA found to reduce the risk of developing liver cancer, but the affect of BCAA on existing liver cancer is unknown. The participants (post curative intent surgery) will be supplemented with either BCAA/non-BCAA-enriched protein supplement. The intervantion will go on for 2 years or until a new liver tumor is found.
Prospective Multicenter Study on Clinical Application of Sonazoid in Liver Tumor
UltrasoundSonazoid as a new generation of ultrasound contrast agent.This study based on the features of Sonazoid specific angiography and his mechanical index, the role of Sonazoidin in the differential diagnosis of benign and malignant focal liver lesions in different liver background was explored
Registry of Major Liver Resections Including ALPPS and Other Liver Resections in Two Stages
Liver NeoplasmsLiver RegenerationRecently a new method of induce similar hypertrophy in the liver as is observed after hepatectomy has been described and was given the eponym "ALLPS". "ALPPS" stands for Associating Liver Partition with Portal Vein Ligation for Staged Hepatectomy (ALPPS). Since the procedure is used worldwide this international registry was created to enable tracking of cases performed worldwide for safety and outcomes and innovations by the groups involved as well as allows a non-randomized comparison to the conventional methods of portal vein occlusion.
Liver-PILP First-in-Man
Liver MetastasesThe purpose of this study is to determine whether the PILP-kit can be safely used, within specific performance parameters, to isolate and perfuse the liver with a chemotherapeutic drug for the treatment of patients with unresectable liver metastases.
Safety and Efficacy of DEB-TACE Performed With a Novel Reflux-control Microcatheter in Patients...
Hepatocellular CarcinomaLiver CancerBACKGROUND: Hepatocellular carcinoma is the fifth most frequent cancer in the world, with a diagnosis of more than 500,000 new cases per year. It is considered the third leading cause of cancer mortality and presents well-defined risk factors. Liver cirrhosis is the main risk factor for developing HCC, therefore screening programs in cirrhotic patients will allow the early diagnosis of this neoplasia. Despite this, most HCCs are diagnosed at a stage in which the application of curative therapies is no longer possible. Hepatic transarterial chemoembolization (TACE) belongs to the arterially directed embolization therapies for the treatment of unresectable early-to-advanced hepatocellular carcinoma (HCC). It is the only therapy that has shown to improve survival in intermediate-stage HCC. Drug-eluting beads (DEB)-TACE has shown to provide slow drug elution, reduced liver and systemic toxicity, increased local drug concentration, and tissue necrosis. Aside from TACE, other transarterial options include bland embolization, or hepatic artery embolization (HAE), and transarterial radioembolization (TARE). All have an acceptable safety profile, and each has its associated procedural and peri-procedural complications. One potential complication that may occur during all embolization procedures is when the embolic material migrates outside of the desired treatment area, leading to non-target embolization (NTE). In fact, when collateral vessels are embolized, there is a risk that these may be feeders of non-target tissue or organs. NTE following TACE in particular may lead to a double-layer problem: dangerous components affecting healthy tissue, one ischemic and one related to cytotoxicity from the chemotherapeutic agent, which may have clinical consequences, and potential incomplete treatment of the lesion (due to beads being "deviated" from target). NTE is highly recognized, but often thought to be uncommon, and although different complications can be caused by it, there may appear to be no evidence of NTE during the intraprocedural imaging. To avoid the complications due to NTE, apart from the importance of the pre-, intra- and post-procedural imaging, and the thorough study of the anatomical picture, the catheters/microcatheters should also be chosen with reason and care. In particular, selective catheterization should be achieved by placing the microcatheter tip as close as possible to the target, through the specific branch/branches supplying it. However, even with the microcatheter selectively positioned in the vessel to be embolized, the risk of NTE might not be eliminated, since it could happen as a result of changes in flow dynamics that occur during embolization, particularly when the endpoint is stasis. These changes could result in reflux into non-target territories and, as such, might be better prevented with the use of microcatheters intended to reduce reflux. To this purpose, the use of a dedicated delivery device should be taken into consideration, in order to optimize and save time during the procedure. Microcatheters are commonly used during most arterial embolization procedures, and as explained above, there is a strong rationale to use a reflux-control microcatheter - like Sequre - for DEB-TACE. The main expectation is to achieve technical success with Sequre in all patients with a reachable target lesion, with the intent not only to minimize potential damage to surrounding tissue, but also to potentially deliver more treatment embolics, as all the beads are (re)directed towards the target. The use of small diameter particles (100 micron-TANDEM ® spheres), induces superior tumor necrosis response (Urbano et al., European Journal of Radiology, 2020); with the synergistic effect of being administered through the SEQURE anti-reflux protection system, there is reason to believe that it will be possible to administer maximum doses of doxorubicin, while avoiding the occlusion of non-target arterial segments (SYNERGIC EFFECT). STUDY PROPOSAL: We propose a prospective observational study with data collection from a single center (Virgen de las Nieves University Hospital-Granada), for a period that ranges October 2020-December 2021. Here summarized the inclusion criteria and contraindications: Inclusion criteria BCLC B and or some case BCLC A Both genders Over 18 years. Bilirubin less than 3 gr/dl. No contraindications to the use of iodinated contrast Absence of chronic kidney disease ECOG 0-1. Absence of encephalopathy. Informed consent. Contraindications Advanced liver disease. Thrombosis or reversal of portal flow. Vascular invasion. Extrahepatic spread. Contraindication to administration of cytostatics. Contraindication to angiographic procedure.
TACE Associated to Systemic Bevacizumab for the Treatment of Refractory Liver Metastases From Colorectal...
Liver Metastasis Colon CancerTransarterial chemoembolization (TACE) is an effective, minimally invasive therapy that is widely used for unresectable colorectal cancer liver metastases (CRC-LM) treatment. Chemoembolization, however, induces a hypoxic micro-environment, which increases neo-angiogenesis, and may promote early progression. For this reason, efficacy may be improved by associating TACE with an angiogenesis inhibitor, such as bevacizumab. The use of FOLFIRI associate to Bevacizumab is part of clinical practice and is commonly used for the therapy of patients with CRC-LM both wild type and mutant. This case-control observational study aim to compare patients treated with TACE using Irinotecan-loaded embolics followed by systemic Bevacizumab versus patients treated with FILFIRI+ Bevacizumab
Precise Treatment in Hepatobiliary Cancers (PTHBC)
Liver NeoplasmsBiliary Tract Neoplasms1 moreThe purpose of this study is to explore the precise treatment in hepatobiliary cancer patients and evaluate drug safety, progression free and overall survival. This trial study is based on genetic tests, then therapeutic target drugs are administered according to the genetic test reports. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit from precise treatment which targets particular genetic abnormality. The identifications of these genetic abnormalities may help treat hepatobiliary cancer patients better.