BACKGROUND AND METHODS: We compared propranolol therapy and endoscopic ligation for the primary prevention of bleeding from esophageal varices. This prospective, controlled trial included consecutive eligible patients who had large varices (>5 mm in diameter) that were at high risk for bleeding. The patients were assigned to either propranolol therapy, at a dose sufficient to decrease the base-line heart rate by 25 percent, or variceal ligation, to be performed weekly until the varices were obliterated or so reduced in size that it was not possible to continue treatment. RESULTS: Of the 89 patients, 82 of whom had cirrhosis of the liver, 44 received propranolol and 45 underwent variceal ligation. The mean (+/-SD) duration of follow-up in each group was 14+/-9 and 13+/-10 months, respectively. The mean time required to achieve an adequate reduction in the heart rate was 2.5+/-1.7 days; the mean number of sessions needed to complete variceal ligation was 3.2+/-1.1. After 18 months, the actuarial probability of bleeding was 43 percent in the propranolol group and 15 percent in the ligation group (P=0.04). Twelve patients in the propranolol group and four in the ligation group had bleeding. Three of the four in the ligation group had bleeding before their varices had been obliterated. Nine patients in the ligation group had recurrent varices, a mean of 3.7 months after the initial treatment. Five patients in each group died; bleeding from the varices was the cause of death of four patients in the propranolol group and of three in the ligation group. There were no serious complications of variceal ligation; in the propranolol group, treatment was stopped in two patients because of side effects. CONCLUSIONS: In patients with high-risk esophageal varices, endoscopic ligation of the varices is safe and more effective than propranolol for the primary prevention of variceal bleeding.
BACKGROUND: Prevention of variceal bleeding, a major cause of morbidity and mortality, is an important goal in the management of patients with portal hypertension (PHT). Although propranolol has been found useful in preventing the first episode of variceal bleeding (primary prophylaxis) in cirrhotic PHT, it has limitations which include side effects, contraindications, non-compliance and failure in some patients. Endoscopic variceal ligation (EVL) has not been used for primary prophylaxis. METHODS: Thirty cirrhotic patients with PHT, grade III to IV oesophageal varices, hepatic venous pressure gradient > or = 12 mmHg and no prior history of upper gastrointestinal bleeding were randomized to receive propranolol (to reduce their pulse rate by 25% from baseline, n = 15) and EVL (weekly to fortnightly until variceal eradication, n = 15). The two groups were comparable. All the patients in EVL group had variceal eradication during 3.8 +/- 2.2 sessions. RESULTS: There was no major complication or interval bleeding. During a follow-up period of 17.6 +/- 4.7 months, varices recurred in three, two of which bled (successfully treated by EVL). In contrast, during this period of follow up one patient in the propranolol group had variceal bleeding (P=NS). Side effects of propranolol included symptomatic bradycardia requiring reduction of dose in one of 15 patients. CONCLUSIONS: Although sample size in this study is small, it seems that EVL may be a good option for primary prophylaxis for variceal bleeding in patients with cirrhotic PHT; further studies on a larger number of patients and longer follow up are required.
BACKGROUND/AIMS: Injection sclerotherapy has been used to prevent the first episode of variceal hemorrhage, but the results are controversial. The value of banding ligation in the prophylaxis of the first episode of variceal bleeding has not yet been completely evaluated. This study was conducted to determine whether prophylactic banding ligation is beneficial for cirrhotic patients with high-risk esophageal varices. METHODS: A total of 127 cirrhotic patients with endoscopically-assessed high-risk esophageal varices but no history of bleeding were randomized to undergo banding ligation (64 patients) or to serve as controls (63 patients). Ligation was performed at 3-week intervals until variceal obliteration was obtained. RESULTS: During a median follow-up of 29 months, 14 patients (21.8%) in the ligation group and 22 patients (34.9%) in the control group experienced upper gastrointestinal bleeding (p = 0.15). Variceal bleeding occurred in eight patients (12.5%) in the ligation group and 14 patients (22.2%) in the control group (p = 0.22). Blood transfusion requirements were fewer in the EVL group than in the control group (0.6+/-0.4 units vs. 1.2+/-0.8 units, p<0.001). Furthermore, variceal bleeding was significantly reduced in Child-Pugh class B patients treated with ligation compared with the control group (p<0.05). Sixteen patients (25%) in the ligation group and 23 patients (36.5%) in the control group died. Comparison of Kaplan-Meier estimates of time to death for the two groups did not show significant differences (p = 0.19). More patients died of uncontrollable variceal bleeding in the control group (7 patients, 11%) than in the ligation group (3 patients, 4.7%) (p = 0.15). CONCLUSIONS: Although prophylactic ligation did not significantly reduce the first episode of bleeding from esophageal varices in cirrhotic patients with high-risk esophageal varices, a subgroup of patients (Child-Pugh class B) had a reduced frequency of the first episode of esophageal variceal bleeding after prophylactic banding ligation. Furthermore, there was a trend of reducing mortality from variceal bleeding in patients receiving prophylactic ligation. Prophylactic ligation is a promising treatment, but requires further investigation.
To determine the efficacy of endoscopic variceal ligation (EVL) in prophylaxis on the rate of first esophageal variceal bleeding, we conducted a prospective, randomized trial in 126 cirrhotic patients with no history of previous upper gastrointestinal bleeding and with esophageal varices endoscopically judged to be at high risk of hemorrhage. The end-points of the study were bleeding and death. Life-table curves showed that prophylactic EVL significantly diminished the rate of variceal hemorrhage (12/62 [19%] vs. 38/64 [60%]; P = .0001) and overall mortality (17/62 [28%] vs. 37/64 [58%]; P = .0011). The 2-year cumulative bleeding rate was 19% (12/ 62) in the EVL group and 60% (38/64) in the control group. The 2-year cumulative mortality rate was 28% (17/62) in the EVL group and 58% (37/64) in the control group. Comparison of Kaplan-Meier estimates of the time to death of both groups showed significantly lower mortality in the ligation group (P = .001). Patients undergoing EVL had few treatment failures and died mainly of hepatic failure. The lower risk in the EVL group was attributed to a rapid reduction of variceal size. Prophylactic EVL was more efficient in preventing first bleeding in patients with good condition (Child A) than in those with decompensated disease (Child B and C). We conclude that prophylactic EVL can decrease the incidence of first variceal bleeding and death over a period of 2 years in cirrhotic patients with high-risk esophageal varices.
<b>OBJECTIVE: </b>To assess the efficacy and safety of endoscopic variceal band ligation (EVL) for primary prophylaxis of variceal bleeding in patients with high-risk varices.<b>DESIGN: </b>A randomized, controlled trial.<b>SETTING: </b>Hospital based.<b>Subjects: </b>Sixty-eight patients with portal hypertension with high-risk varices were randomized to undergo either EVL (n = 35) or no treatment (n = 33).<b>INTERVENTIONS: </b>Endoscopic variceal band ligation or no therapy.<b>MAIN OUTCOME MEASURES: </b>Probability of first variceal bleeding, probability of survival, variceal obliteration, complications of EVL.<b>RESULTS: </b>Oesophageal varices could be obliterated by EVL in 3.2 +/- 1.2 sessions within 4.9 +/- 2.2 weeks. Three (8.6%) patients in the EVL group and 13 (39.4%) in the control group bled during a mean follow-up of 14.1 +/- 5.0 months (range 2-22) (P < 0.01). The cumulative probability of the patients remaining free of bleeding was higher (P < 0.01) in the EVL group than the control. Variceal recurrence was seen in 10 (28.6%) patients and was managed by repeated EVL. None of the patients developed oesophageal stricture. Four (11.4%) patients in the EVL and eight (24.2%) in the control group died (P = NS). Bleed-related mortality was lower in the EVL than the control group (2.9% vs. 15.2%, P = 0.08).<b>CONCLUSION: </b>EVL significantly decreases the frequency of first variceal bleed. It should be evaluated further to see if bleeding-related mortality could be reduced in cirrhotics with high-risk varices who have not bled.
