VSL#3 ® probiotic therapy does not reduce portal pressures in patients with decompensated cirrhosis.

BACKGROUND & AIMS: In patients with decompensated cirrhosis, bacterial translocation can contribute to splanchnic vasodilatation, decreased effective circulating volume, and portal hypertension. The primary objective of this randomized, double blind placebo controlled trial was to evaluate the effect of the probiotic VSL#3(®) on the hepatic venous pressure gradient (HVPG). METHODS: Seventeen patients with decompensated cirrhosis and an HVPG of ≥ 10 mmHg were randomized to receive 2 months of VSL#3(®) or an identical placebo. HVPG, endotoxin, interleukin (IL)-6, IL-8, IL-10, renin, aldosterone, nitric oxide and stool microbiota were measured at baseline and study end. RESULTS: Two of the 17 patients were taken off the trial before completion (one for alcohol abuse and the second for SBP - both in placebo arm). Data were analysed on the remaining 15 patients. The median model for end-stage liver disease score was 12, and 80% of patients had Child Pugh B disease. The treatment arm had a greater decrease in HVPG from baseline to study end than the placebo arm (median change from baseline -11.6% vs +2.8%), although this reduction was not statistically significant in either group. There was a significant reduction in the plasma aldosterone level in the VSL#3(®) group, but no significant changes in the other measured parameters, including the stool microflora analysis. CONCLUSIONS: Within the limitations of our sample size, VSL#3(®) therapy does not appear to have a significant impact on portal pressure reduction in patients with decompensated cirrhosis.

Transarterial chemoembolization in patients with hepatocellular carcinoma: predictors of survival.

BACKGROUND: Transarterial chemoembolization (TACE) is the mainstay of management for patients with hepatocellular carcinoma who are not suitable for curative treatments. OBJECTIVE: To determine factors associated with mortality after the first TACE procedure. METHODS: From January 2004 to May 2008, 60 patients underwent TACE as treatment for hepatocellular carcinoma. Clinical and biochemical parameters before TACE, and response after TACE, were evaluated with conventional classifications (WHO, Response Evaluation Criteria in Solid Tumors [RECIST], and European Association for the Study of the Liver [EASL] criteria) and with one-, two- and three-dimensional assessment. RESULTS: Overall median survival after the first TACE procedure was 17.1±3.4 months. According to Cox regression analysis, having an alpha-fetoprotein level of greater than 200 ng/mL (HR 2.35 [P=0.02]) and a Model for End-stage Liver Disease (MELD) score of greater than 10 (HR 4.19 [P=0.001]) were associated with higher risk of mortality; whereas reduction in tumour size measured in one dimension (HR 0.96 [P=0.005]), two dimensions (HR 0.98 [P=0.004]) and three dimensions (HR 0.98 [P=0.001]) was associated with lower risk of mortality. Moreover, reduction in tumour size by 3% or more assessed in one, two or three dimensions was associated with lower risk of mortality (HR 0.48 [P=0.04]; HR 0.36 [P=0.01]; HR 0.31 [P=0.003], respectively). The three conventional classifications were not useful for predicting mortality (WHO: HR 1.07 [P=0.9]; RECIST: HR 0.94 [P=0.9]; EASL: HR 0.94 [P=0.9]). CONCLUSIONS: Having an alpha-fetoprotein level of greater than 200 ng/mL and a MELD score of greater than 10 before undergoing TACE was associated with a greater risk of mortality. Conventional classifications of response were not useful for predicting mortality. Reduction in tumour size after the first TACE procedure was associated with better survival, primarily if patients had more than a 3% reduction in tumour size assessed by three-dimensional measurement.

Percutaneous transhepatic pancreatic islet cell transplantation in type 1 diabetes mellitus: radiologic aspects.

PURPOSE: To report our experience with percutaneous transhepatic pancreatic islet cell transplantation in patients with type 1 diabetes mellitus. MATERIALS AND METHODS: Between March 1999 and May 2002, 34 patients underwent 68 islet cell transplantation procedures. Patients with C-peptide-negative type 1 diabetes were selected on the basis of poor metabolic control (hypoglycemia or lability) despite compliance with optimal medical therapy. Islet cells were isolated from brain-dead donors. Access to the portal vein was gained from a right percutaneous transhepatic approach, and islet cells were infused with intermittent pressure monitoring. Twenty patients underwent two transplantations, seven patients underwent three transplantations, and seven patients underwent one transplantation. Complications during and after the procedure and postprocedural diabetic status were monitored. RESULTS: Successful portal vein cannulation and islet cell infusion were achieved in all cases. Fluoroscopy was used as the primary guidance modality in 58 of 68 (85%) procedures, and ultrasonography was used in 10 of 68 (15%). Total recorded fluoroscopy time varied from 0.6 to 103 minutes, with a median of 6.9 minutes. Potentially serious complications occurred in six of 68 (9%) procedures. Two patients developed portal venous thrombosis, and with subsequent anticoagulation therapy, one of the two developed an expanding hepatic hematoma that required surgery. Clinically important hemorrhage occurred in four patients, three of whom required blood transfusions. Of 26 patients who received completed transplants, all became insulin independent, and 81% (21 of 26) remained insulin free at 1 year. CONCLUSION: The percutaneous transhepatic approach for the implantation of islet cells into the portal vein is a safe procedure, and together with use of current cell separation techniques and an immunosuppressive regimen, offers a marked advance in the treatment of type 1 diabetes mellitus.