Pilot study: Gelafundin (polygeline) 4% plus antibiotics in the treatment of high-risk cirrhotic patients with spontaneous bacterial peritonitis.

BACKGROUND: Cirrhotic patients with spontaneous bacterial peritonitis (SBP) have elevated rates of renal impairment and mortality. It has been shown that cefotaxime plus albumin infusion decrease renal impairment compared with antibiotic treatment alone, in patients with serum bilirubin >4 mg/dL or creatinine >1 mg/dL. AIM: To assess clinical outcomes of high-risk cirrhotic patients with SBP who were treated with antibiotics associated with Gelafundin (polygeline) 4%. METHODS: Twenty nine cirrhotic patients with SBP and serum bilirubin >4 mg/dL or creatinine >1 mg/dL were enrolled. Ceftriaxone was administered in doses of 2 g/day and Gelafundin 4% was given intravenously at 1.5 g/kg of body weight at the time of the diagnosis, followed by 1 g/kg on day 3. Renal impairment was defined as nonreversible deterioration of renal function during hospitalization. RESULTS: Eight patients (27.5%) had basal renal failure. Infection resolved in 28 (96.6%) patients. Renal impairment occurred in four patients (13.8%), and three patients (10.4%) died during hospitalization. Mortality within 90 days after discharge was 34.5% (10 patients). CONCLUSION: The rates of renal impairment and mortality in high-risk patients with SBP suggest that Gelafundin 4% administration given with ceftriaxone may be a less expensive therapeutic alternative to albumin.

Clinical trial: short-term effects of combination of satavaptan, a selective vasopressin V2 receptor antagonist, and diuretics on ascites in patients with cirrhosis without hyponatraemia--a randomized, double-blind, placebo-controlled study.

BACKGROUND: There is little information on the effects of vaptans in patients with cirrhosis. AIM: To investigate the short-term effects of satavaptan, a selective vasopressin V2 receptor antagonist on ascites in cirrhosis without hyponatraemia. METHODS: A total of 148 patients with cirrhosis, ascites and serum sodium >130 mmol/L were included in a multicentre, double-blind, randomized, controlled study of 14 days comparing three fixed doses of satavaptan (5 mg, 12.5 mg or 25 mg once daily) vs. placebo. Average MELD scores were: 13.4, 12.3, 13.8 and 13.1 respectively. All patients received spironolactone 100 mg/day plus furosemide 20-25 mg/day. RESULTS: Satavaptan treatment was associated with a decrease in ascites (mean change in body weight was -0.36 kg (+/-3.03) for placebo vs. -2.46 kg (+/-3.11), -2.08 kg (+/-4.17) and -2.28 kg (+/-3.24) for the 5 mg, 12.5 mg and 25 mg doses respectively; P = 0.036, P = 0.041 and P = 0.036 for satavaptan 5, 12.5 and 25 mg/day vs. placebo respectively). Thirst and slight increases in serum sodium were more common in patients treated with satavaptan compared with placebo, while other adverse events were similar. CONCLUSIONS: The administration satavaptan for a 14-day period is associated with reduction in ascites in patients with moderately severe cirrhosis without hyponatraemia under diuretic treatment.

Comparative study between nadolol and 5-isosorbide mononitrate vs. endoscopic band ligation plus sclerotherapy in the prevention of variceal rebleeding in cirrhotic patients: a randomized controlled trial.

BACKGROUND: After variceal bleeding, cirrhotic patients should receive secondary prophylaxis. AIM: To compare nadolol plus 5-isosorbide mononitrate (5-ISMN) with endoscopic band ligation. The end points were rebleeding, treatment failure and death. METHODS: One hundred and nine cirrhotic patients with a recent variceal bleeding were randomized: nadolol plus 5-ISMN in 57 patients and endoscopic band ligation in 52 patients. RESULTS: The mean follow-up was 17 and 19 months in nadolol plus 5-ISMN and endoscopic band ligation groups, respectively. No differences were observed between groups in upper rebleeding (47% vs. 46%), variceal rebleeding (40% vs. 36%), failure (32% vs. 22%), major complications (7% vs. 13.5%) and death (19% vs. 20%), respectively. The actuarial probability of remaining free of rebleeding, failure and deaths were similar in both groups. Time to rebleeding shows that endoscopic band ligation patients had an early rebleed, with a median of 0.5 month (95% CI: 0.0-4.2) compared with patients from nadolol plus 5-ISMN, 7.6 months (95% CI: 2.9-12.3, P < 0.013). Multivariate analysis indicated that outcome-specific predictive factor(s) for rebleeding was Child A vs. B + C (P < 0.01); for failure was Child A vs. B + C (P < 0.02); and for death ascites (P < 0.01) and rebleeding (P < 0.02). CONCLUSION: This trial suggests no superiority of endoscopic band ligation over nadolol plus 5-ISMN mononitrate for the prevention of rebleeding in cirrhotic patients.

Long-term efficacy of torsemide compared with frusemide in cirrhotic patients with ascites.

BACKGROUND: Torsemide is a new loop diuretic that has shown, in short-term studies, to induce a longer and higher diuretic and natriuretic action than frusemide. However, torsemide long-term effects and complications have not been sufficiently investigated. The aim was to compare the efficacy and safety of torsemide versus frusemide in cirrhotic patients with uncomplicated ascites. METHODS: Forty-six patients were randomized in two groups to receive torsemide 20 mg/day (n = 22) or frusemide 40 mg/day (n = 24). Both drugs were administered in association with spironolactone 200 mg/day. The initial doses of diuretics were increased every 3 days up to 60, 120 and 400 mg/day, respectively, if the body weight loss was less than 300 g/day or natriuresis was below 50 mEq/day. RESULTS: Torsemide induced a significantly greater diuretic response than frusemide at 24 h and the maximum diuresis while mean diuresis was similar in both groups. Natriuresis was also higher with torsemide but the difference was not significant. The body weight loss, the treatment period, the ascites resolution and complications were similar in both groups. Diuretic doses were increased in two patients treated with torsemide and in nine patients treated with frusemide (P < 0.05). CONCLUSIONS: These results show that torsemide is as effective and safe as frusemide for long-term treatment of cirrhotic patients with ascites.

Oral ciprofloxacin after a short course of intravenous ciprofloxacin in the treatment of spontaneous bacterial peritonitis: results of a multicenter, randomized study.

BACKGROUND/AIMS: Oral quinolones have been suggested as treatment of cirrhotic patients with uncomplicated spontaneous bacterial peritonitis. To evaluate the efficacy of oral quinolones in all patients with this complication, oral ciprofloxacin after a short course of intravenous (i.v.) ciprofloxacin was compared to i.v. ciprofloxacin. METHODS: Eighty patients were allocated to receive ciprofloxacin i.v. 200 mg/12 h for 7 days (group A, n= 40) or i.v. 200 mg/12 h during 2 days followed by oral 500 mg/12 h for 5 days (group B, n=40). All patients with spontaneous bacterial peritonitis admitted to the hospital were included. Twenty-five variables obtained 48 h after treatment were introduced into univariate and multivariate analyses to identify predictors of survival and outcome. RESULTS: In the baseline condition, no differences were found between the two groups in clinical data, hepatic and renal function tests and Child Pugh score. The infection resolution rate was 76.3 % in group A and 78.4 % in group B, and hospital survival was 77.5% in both groups. In multivariate analysis serum creatinine and serum leukocytes 48 h after treatment were associated with prognosis. CONCLUSIONS: Oral ciprofloxacin after a short course of i.v. ciprofloxacin is effective in the treatment of spontaneous bacterial peritonitis. This regimen can be applied to all patients admitted to the hospital with this complication, and could be an alternative to treating these patients as outpatients.

Patients with ascites have higher variceal pressure and wall tension than patients without ascites.

OBJECTIVE: It has been suggested that ascites is a risk factor for variceal bleeding. Recently, it has been demonstrated that total paracentesis decreases variceal pressure. However, no data are available showing the basal variceal pressure in patients with and without ascites. METHODS: We studied 76 cirrhotic patients, 49 with and 27 without ascites. Variceal pressure was measured by direct puncture. Variceal size, variceal pressure gradient, and variceal wall tension were also obtained. RESULTS: No demographic differences were observed between the groups. Child score was higher (9.7+/-1.5 vs 7.8+/-2.1, p < 0.001) and serum albumin lower (2.6+/-0.6 vs 3.0+/-0.7 mg %, p < 0.02) in ascitic than in nonascitic patients, respectively. Variceal pressure and variceal pressure gradient were significantly higher in patients with ascites than in those without ascites (25.0+/-6 vs 20.4+/-4.6 mm Hg, p < 0.001 and 18.75+/-4.7 vs 13.70+/-4.1 mm Hg, p < 0.0001, respectively). The variceal wall tension was significantly higher in patients with ascites (71.0+/-25.1 mm Hg/mm) than in those without ascites (55.1+/-22.1 mm Hg/mm, p < 0.03). No relationship was observed between variceal pressure gradient and liver function. Ascites patients included in Child-Pugh grade A+B presented a similar variceal pressure to Child C patients (18.5+/-4.2 vs 19.3+/-5.7 mm Hg, respectively, p = ns). In addition, no relationship was observed between variceal pressure gradient and etiology of cirrhosis. CONCLUSION: Our results demonstrate that patients with ascites have significantly higher variceal pressure and wall tension than patients without ascites. These results suggest that patients with ascites may be at risk for variceal bleeding.

Efficacy of octreotide and sclerotherapy in the treatment of acute variceal bleeding in cirrhotic patients. A prospective, multicentric, and randomized clinical trial.

BACKGROUND: Sclerotherapy is the most widely used method for treatment of acute variceal bleeding. Previous reports have suggested that octreotide infusion is as effective as sclerotherapy. Our aim was to investigate the efficacy and safety of octreotide in comparison with sclerotherapy in controlling variceal bleeding. METHODS: Seventy-six cirrhotic patients were randomized to receive either sclerotherapy (n = 37) or octreotide (n = 39) infusion of 50 microg/h intravenously for 48 h after a bolus of 100 microg, followed by subcutaneous injection of 100 microg/8 h for an additional 72 h. RESULTS: The two groups were similar in base-line data. A similar initial control of bleeding was obtained in 94.6% for sclerotherapy and 84.6% for octreotide (NS). No difference was observed between sclerotherapy and octreotide in rebleeding (23% versus 33%) and treatment failure (22% versus 36%, respectively). Furthermore, the overall success of treatment was 78% for sclerotherapy and 64% for octreotide. No significant difference in mortality was observed between treatments (eight patients for octreotide and three patients for sclerotherapy, NS). CONCLUSIONS: These results show that both treatments present a very high and similar initial and final control of bleeding. However, there is a trend that could be clinically important towards better results in the patients treated with sclerotherapy.

Terlipressin is more effective in decreasing variceal pressure than portal pressure in cirrhotic patients.

BACKGROUND/AIMS: Terlipressin decreases portal pressure. However, its effects on variceal pressure have been poorly investigated. This study investigated the variceal, splanchnic and systemic hemodynamic effects of terlipressin. METHODS: Twenty cirrhotic patients with esophageal varices grade II-III, and portal pressure > or =12 mmHg were studied. Hepatic venous pressure gradient, variceal pressure and systemic hemodynamic parameters were obtained. After baseline measurements, in a double-blind administration, 14 patients received a 2mg/iv injection of terlipressin and six patients received placebo. The same measurements were repeated 60 min later. RESULTS: No demographic or biochemical differences were observed in basal condition between groups. Terlipressin produced significant decreases in intravariceal pressure from 20.9+4.9 to 16.3+/-4.7 mmHg (p<0.01, -21+/- 16%), variceal pressure gradient from 18.9+/-4.8 to 13.5+/-6.0 mmHg (p<0.01, -28+/-27%), estimated variceal wall tension from 78+/-29 to 59+/-31 mmHg x mm (p<0.01, -27+/-22%), and hepatic venous pressure gradient from 19.4+/-4.5 to 16.8+/-5 mmHg (p<0.01, -14+/-12%) at 60 min. The change in variceal pressure after 60 min of terlipressin administration was greater than the change in wedge hepatic venous pressure (-4.7 mmHg vs -0.5 mmHg, respectively, p<0.0001). Terlipressin also caused significant decreases in heart rate and cardiac index and increases in mean arterial pressure and peripheral vascular resistance. CONCLUSIONS: Our results demonstrate that terlipressin produces significant and prolonged decreases in variceal pressure and variceal wall tension and has intrinsic effects on portal pressure and systemic hemodynamics. Variceal pressure provides a better assessment of the effects of terlipressin administration on esophageal varices than hepatic venous pressure gradient.

Interferon-alpha 2b combined with daily ketoprofen administration improves virological response in chronic hepatitis C: a prospective and randomised trial.

BACKGROUND: Less than 15% of patients with chronic hepatitis C show a sustained virological response to interferon treatment. AIM: To evaluate the efficacy and safety of different doses of ketoprofen combined with interferon-alpha 2b in the treatment of chronic hepatitis C. PATIENTS/METHODS: Seventy compensated patients with chronic hepatitis C received interferon-alpha 2b 3 million units three times a week for six months. They were randomly assigned to: group 1 (n = 23), interferon-alpha 2b alone; group 2 (n = 23), interferon-alpha 2b plus 200 mg ketoprofen three times a week; group 3 (n = 24), interferon-alpha 2b plus 200 mg ketoprofen twice a day. Complete and sustained responses were defined as normal serum alanine aminotransferase levels and negative serum hepatitis C virus RNA at six and 12 months respectively. RESULTS: Complete and sustained responses were similar in groups 1 and 2: 10% v 5% and 5% v 0% respectively. In group 3, complete response was 29% (p = 0.13 v group 1 and p = 0.04 v group 2) and sustained response was 26% (p = 0.07 v group 1 and p = 0.01 v group 2). Overall, adverse events were similar in the three groups. However, 'flu-like syndrome was less common in group 2 (30%) and group 3 (37%) than in group 1 (77%) (p = 0.01). CONCLUSIONS: Twice daily ketoprofen administration combined with interferon-alpha 2b produced an increase in complete and sustained responses. Although the combination of interferon-alpha 2b with ketoprofen was well tolerated and decreased the incidence of 'flu-like syndrome, it is advisable to monitor possible non-steroid anti-inflammatory drug hepatotoxicity.

Variceal band ligation and variceal band ligation plus sclerotherapy in the prevention of recurrent variceal bleeding in cirrhotic patients: a randomized, prospective and controlled trial.

BACKGROUND: The combination treatment of band ligation plus sclerotherapy has been proposed to hasten variceal eradication. The aim of this study was to assess the efficacy of band ligation alone versus band ligation plus sclerotherapy in the prevention of recurrent variceal bleeding. METHODS: Eighty cirrhotic patients were randomized to group I (band ligation) with 41 patients or to group II (band ligation plus sclerotherapy) with 39 patients in whom polidocanol (2%) was injected 1 to 2 cm proximal to each band. RESULTS: At baseline, both groups were similar with regard to clinical, demographic and laboratory data. Mean follow-up time (standard error) for group I was 336.5 +/- 43.4 days and for group II 386.1 +/- 40.1 days (p = 0.4). No statistical differences were observed between group I and group II in relation to recurrence of bleeding (31.7% vs. 23%, p = 0.38), treatment failure (24.4% vs. 12. 8%, p = 0.18), death (39% vs. 30.8%, p = 0.44) and variceal eradication (65.8% vs. 74.4%, p = 0.40). Group II had a significantly higher number of complications than group I, 30.8% versus 7.3%, respectively (p = 0.05). The number of bleeding related deaths was higher in group I than in group II (22% vs. 10.3%, respectively; p = 0.15). CONCLUSIONS: No significant difference was observed between band ligation and band ligation plus sclerotherapy in prevention of recurrent variceal bleeding. Furthermore, there was a higher incidence of complications in the latter group.

Lidocaine and monoethylglycinexylidide serum determinations to analyze liver function of cirrhotic patients after oral administration.

Our aim was to compare standard liver function tests (serum bilirubin, serum albumin and prothrombin concentration), with lidocaine and monoethylglycinexylidide pharmacokinetic parameters, after oral lidocaine administration, to assess hepatic function of cirrhotic individuals. Twenty-one consecutive cirrhotic patients, nine consecutive acute hepatitis patients, and nine healthy individuals received oral lidocaine. Lidocaine and monoethylglycinexylidide serum concentrations were determined by the TDx system. Cirrhotic patients had higher lidocaine and lower monoethylglycinexylidide serum concentrations and differences in its pharmacokinetic variables, compared to control and hepatitis groups (P < 0.05). Sensitivity of lidocaine serum determinations (100%) was greater than sensitivity of serum bilirubin (57%), serum albumin (62%), and prothrombin concentrations (43%) and monoethylglycinexylidide serum concentrations (57%) in differentiating cirrhotic individuals from controls. In conclusion, after oral administration, lidocaine and monoethylglycinexylidide pharmacokinetic parameters are significantly altered in cirrhotic patients compared to normal and acute hepatitis subjects. Lidocaine pharmacokinetic parameters would be better than those of monoethylglycinexylidide and standard liver function tests in the evaluation of liver function of cirrhotic patients.

Effects of oral ciprofloxacin on aerobic gram-negative fecal flora in patients with cirrhosis: results of short- and long-term administration, with daily and weekly dosages.

BACKGROUND/AIMS: Selective intestinal decontamination has been proposed to prevent spontaneous bacterial peritonitis in cirrhosis. Because of the cost of antibiotics and the development of resistant bacteria, we have evaluated the effect of different schemes and doses of oral ciprofloxacin on aerobic gram-negative fecal flora in cirrhotic patients. METHOD: Twenty-nine cirrhotic patients were allocated to four groups to receive: Group 1: 500 mg/day for 2 weeks (six patients); Group 2: 1000 mg twice a week for 2 weeks (six patients); Group 3: 1000 mg once a week for 2 weeks (six patients); and Group 4: 1000 mg once a week for 12 weeks (11 patients). Quantitative analysis of the gram-negative fecal flora was performed before and 1 and 2 weeks after initiation of treatment in patients in Groups 1, 2 and 3 and before and 4, 8 and 12 weeks after initiation of treatment in patients in Group 4. RESULTS: Complete eradication of gram-negative bacilli was observed in four of six patients in Group 1. In contrast, only one patient eradicated gram-negative bacilli in Group 2 and Group 3. In long-term administration of ciprofloxacin (Group 4), only two of 11 patients had persistent eradication of gram-negative bacilli. Four patients developed E. coli resistant to ciprofloxacin (one of them associated to resistant Klebsiella). No patient developed bacterial infection during the study period. CONCLUSION: Oral ciprofloxacin administered in a weekly dose is ineffective in selective intestinal decontamination. Different mechanisms, including the emergence of ciprofloxacin-resistant organisms, could account for this failure. Therefore, our results suggest that weekly administration of ciprofloxacin is not useful in preventing spontaneous bacterial peritonitis.

Gluten sensitivity in patients with primary biliary cirrhosis.

OBJECTIVE: Whereas celiac disease and primary biliary cirrhosis have been reported to coexist in the same patient, the frequency of this relationship has not been clarified. Nowadays, the concept of celiac disease has been extended from that of a severe enteropathy to a broader concept of gluten-driven intestinal immunological response. In this study we assessed features of gluten sensitivity in a cohort of patients with primary biliary cirrhosis. METHODS: Ten patients with primary biliary cirrhosis were evaluated a mean of 2 yr after diagnosis. The following features of gluten sensitivity were assessed: serum antigliadin and endomysial antibodies, small bowel histology (degree of atrophy and quantitative histological parameters), the presence of the typical celiac HLA genotype (DQ2), and intraepithelial lymphocyte response in the rectal mucosa after local gluten instillation (rectal gluten challenge). RESULTS: Overall, three patients presented evidence of gluten sensitivity. All three had abnormal titers of antigliadin antibody type IgA and one was positive for endomysial antibody. Two patients had partial villous atrophy. The rectal gluten challenge showed a celiac-like response, evidenced by an increase in intraepithelial lymphocyte infiltration after gluten exposure, in the three patients. The characteristic celiac HLA genotypes (DQA1 0501 and DQB1 0201) were identified in three patients. One of them also exhibited other features of gluten sensitivity. However, despite evidence of gluten intolerance, patients had minimal or no symptoms characteristic of celiac disease. CONCLUSION: We detected features of gluten sensitivity in a high proportion of patients with primary biliary cirrhosis. Further studies should be performed to elucidate the clinical significance of this association.

Hemostatic and hemodynamic effects of vasopressin analogue DDAVP in patients with cirrhosis

Desmopressin (DDAVP), a synthetic analogue of vasopressin, has been shown to improve the bleending time in patients with cirrhosis. The duration of this effect and the hemodynamic changes associated with DDAVP have been studied so far. To evaluate these issues, 14 cirrhotics with portal hypertension were studied in basal conditions and after DDAVP (0.3 uk/kg). In 8 patients, hemostatic tests were done at basal conditions and 1,3,6 and 24 hs after drug administration. In the remaining 6 patients, mean arterial pressure, cardiac output, portal and femoral blood flows were evaluated. Hemodynamic parameters were measured by Doppler ultrasound. DDAVP caused a marked decrease in bleeding time at 1,3,6 and 24 hs (14+9 vs 8+3, 7+4, 6+4 and 8+4 min, respectively); the decrease was maximal and statiscally significant at 6 hs (55+15 percent, p<0.02) after DDAVP infusion. Bleeding time reduction was observed in every patient studied. In the hemodynamic study, DDAVP caused a mild but significant decrease in mean arterial pressure (12+8 percent, p<0.05); no significant changes were observed in the rest of hemodynamic parameters studied. These findings show that DDAVP can be used to shorten the bleeding time for a period of at least 24 hs in patients with cirrhosis, without deleterious hemodynamic effects. This beneficial effect may be of potential relevance in the medical management of patients with chronic liver diseases.

Hemostatic and hemodynamic effects of vasopressin analogue DDAVP in patients with cirrhosis

Desmopressin (DDAVP), a synthetic analogue of vasopressin, has been shown to improve the bleending time in patients with cirrhosis. The duration of this effect and the hemodynamic changes associated with DDAVP have been studied so far. To evaluate these issues, 14 cirrhotics with portal hypertension were studied in basal conditions and after DDAVP (0.3 uk/kg). In 8 patients, hemostatic tests were done at basal conditions and 1,3,6 and 24 hs after drug administration. In the remaining 6 patients, mean arterial pressure, cardiac output, portal and femoral blood flows were evaluated. Hemodynamic parameters were measured by Doppler ultrasound. DDAVP caused a marked decrease in bleeding time at 1,3,6 and 24 hs (14+9 vs 8+3, 7+4, 6+4 and 8+4 min, respectively); the decrease was maximal and statiscally significant at 6 hs (55+15 percent, p<0.02) after DDAVP infusion. Bleeding time reduction was observed in every patient studied. In the hemodynamic study, DDAVP caused a mild but significant decrease in mean arterial pressure (12+8 percent, p<0.05); no significant changes were observed in the rest of hemodynamic parameters studied. These findings show that DDAVP can be used to shorten the bleeding time for a period of at least 24 hs in patients with cirrhosis, without deleterious hemodynamic effects. This beneficial effect may be of potential relevance in the medical management of patients with chronic liver diseases. (AU)

Daily variation in portal blood flow and the effect of propranolol administration in a randomized study of patients with cirrhosis.

A nocturnal increase in portal pressure and blood flow was demonstrated in patients with cirrhosis, suggesting that these hemodynamic changes may contribute to the triggering of the hemorrhagic episodes observed during the night in these patients. It is known that propranolol reduces portal flow, thus reducing the risk of variceal bleeding. In a double-blind, placebo-controlled study, we evaluated the effect of long-term propranolol administration on the daily fluctuation of systemic and splanchnic hemodynamic parameters in 14 patients with cirrhosis. Cardiac output and portal blood flow were measured by the Doppler technique. A daily fluctuation of both cardiac output and portal blood flow was observed, peaking at midnight. beta-Adrenergic blockade was manifested by a significant reduction in heart rate (-21% +/- 4%, P < .01) and cardiac output (-12% +/- 2%, P < .05). A significant decrease in portal blood flow (-20% +/- 4%, P < .01) was also observed in these patients. Propranolol administration blunted the time-related changes in cardiac output and portal blood flow. In contrast, patients receiving placebo had a nocturnal peak of both parameters similar to that observed under basal conditions. Our study shows that chronic propranolol administration abolishes the nocturnal peak of portal blood flow in patients with cirrhosis and indicates a preventive effect of propranolol in these patients.

Total volume paracentesis decreases variceal pressure, size, and variceal wall tension in cirrhotic patients.

It has been suggested that ascites is a risk factor for variceal bleeding in cirrhotic patients. However, no data of total volume paracentesis (TVP) effects on variceal hemodynamics has yet been published. The aim of this study was to investigate the effects of TVP on variceal pressure, size, and tension in cirrhotic patients. Before sclerotherapy, 18 cirrhotic patients with grade II esophageal varices were studied. The following measurements were performed on 12 patients at basal condition and after TVP: inferior vena cava pressure, esophageal pressure (EP), and intravariceal pressure (IVP) by direct punction and variceal size at endoscopy. The same measurements were performed at basal condition and 1 hour later without TVP on the other 6 patients used as a control group. Variceal pressure gradient (VPG) and variceal wall tension (WT) were calculated. Paracentesis and intra-abdominal pressure were obtained with a direct punction. No demographic differences were observed between both groups. Paracentesis produced a significant reduction of IVP (from 25.6 +/- 2.4 to 17.9 +/- 2.1 mm Hg, means +/- SEM, -30%, P < .05), VPG (from 16.6 +/- 2.4 to 10.8 +/- 1.4 mm Hg, -35%, P < .05). TVP also reduced variceal size (from 9 +/- 0.3 to 5.6 + 0.4 mm, -38%, P < .05) and WT (from 75.3 +/- 11.6 to 30 +/- 4.7 mm Hg. mm, -60%, P < .05). Intra-abdominal pressure decreased from 18 +/- 2.2 to 4 +/- 0.9 mm Hg (P < .05), and IVC decreased from 15.5 +/- 2.4 to 5.7 +/- 1.5 mm Hg (P < .05). No significant differences were observed in mean arterial pressure and heart rate. The mean ascitic fluid removed was 8 +/- 0.71 L. No significant difference between measurements was observed in the control group. Our results show that TVP significantly decreases variceal pressure and tension. These results suggest that ascites removal can be useful in the treatment of variceal bleeding in cirrhotic patients.