Similar performance but higher cholecystitis rate with covered biliary stents: results from a prospective multicenter evaluation.

BACKGROUND AND STUDY AIMS: Endoscopic biliary stenting is now a well-established treatment method in patients with unresectable malignant biliary obstruction. Despite advances with metal stents, the problem of stent occlusion has not yet been resolved. Covered metal stents could reduce the occlusion rate by preventing tumor ingrowth, but have not been well evaluated. A prospective multicenter study was therefore conducted to evaluate the efficacy and disadvantages of covered Wallstents. PATIENTS AND METHODS: Covered Wallstents were implanted endoscopically in 62 patients with inoperable distal malignant biliary obstruction. Complications, stent patency, and patient survival were analyzed. RESULTS: Stent insertion was achieved in 61 of the 62 patients (98.4 %). Procedure-related complications were observed in four patients, consisting of minor pancreatitis (n = 2) and abdominal pain due to stent expansion (n = 2). There was no procedure-related mortality. Seven patients died too early for proper assessment, so that a total of 54 patients were ultimately evaluated. Stent dysfunction occurred in 17 of the 54 patients (31.5 %). The reasons for dysfunction were proximal tumor overgrowth (n = 5), migration (n = 3), lithiasis or food impaction (n = 3), cholangitis without the need for a repeat biliary intervention (n = 5), and unknown (n = 1). The median period of stent patency was 142 days. No tumor ingrowth was observed. Acute cholecystitis was diagnosed in five patients (10 %) and was responsible for one death. Three stents were successfully removed. CONCLUSIONS: Covered biliary metal stents are effective for the drainage of distal malignant biliary obstruction, with a dysfunction rate apparently similar to that of uncovered stents. However, the risk of acute cholecystitis appears to be a major concern with this type of stent in patients with gallbladder in situ. Further comparative studies are needed.

Is intravenous administration of branched chain amino acids effective in the treatment of hepatic encephalopathy? A multicenter study.

The influence of intravenous infusion of branched-chain amino acids (BCAAs) on brain function in patients with liver cirrhosis and acute hepatic encephalopathy was examined using a double-blind, randomized study design. Five medical centers in France and Sweden participated, and 50 patients were studied. The patients received either BCAAs (40 gm per day) in 5% glucose or 5% glucose alone (placebo) for 5 days or until "wake up". Nutritional support was provided with equal proportions of carbohydrate and fat. During BCAA administration, plasma concentrations of aromatic amino acids and methionine fell (20 to 40%, p less than 0.05 to 0.01), and the ratio of BCAAs to aromatic amino acid concentrations increased significantly. Clinical improvement was seen in 14 of 25 BCAA-treated patients and in 12 of 25 patients receiving placebo (N.S.). EEG responses were similar in the two groups during treatment. In the BCAA group, 10 of 25 patients died in the course of the study, compared to 5 of 25 in the placebo group (N.S.); six patients died from encephalopathy in the BCAA group as compared to three among placebo-treated patients. It is concluded that BCAA administration, in the dose and composition employed in the present study, reduces the concentrations of aromatic amino acids but neither improves cerebral function nor decreases mortality in patients with hepatic encephalopathy.