Primary studies included in this systematic review

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Publication Thread

Drastich P

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Primary study

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Endoscopic band ligation versus propranolol for the primary prophylaxis of variceal bleeding in cirrhotic patients with high risk esophageal varices.

Journal Annals of hepatology
Year 2010
Links Pubmed DOI

This article is included in 3 Systematic reviews Systematic reviews (3 references) 1 Broad synthesis Broad syntheses (1 reference)

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BACKGROUND: Gastroesophageal variceal bleeding is a common complication of portal hypertension. Current guidelines recommend thorn-blockers for primary prophylaxis. However, evidence suggests that endoscopic variceal ligation (EVL) reduce bleeding episodes. AIMS: To compare endoscopic EVL with propranolol (PPL) for primary prophylaxis of variceal bleeding. METHODS: We conducted a randomized controlled trial. Over a 9-year period, 75 patients with cirrhosis and high-risk esophageal varices (HREV) were recruited and allocated to EVL (n=39) or PPL (n=36). Primary outcome was variceal bleeding. Secondary outcomes were survival, source of bleeding and serious adverse events. Analyses were made by intention-to-treat. RESULTS: Baseline characteristics were similar. Medium follow-up was 1647+/-1096 days. complete follow-up was achieved in 85% of patients. Variceal bleeding occurred in 12% of EVL and in 25% of PPL group (p=0.17). The actuarial risks of bleeding after 2 years were similar in both groups. Overall mortality was 51% in EVL and 33% in PPL group (p=0.17). Patients in the EVL group showed a lower rate of esophageal variceal bleeding (5.1% v/s 25%, p=0.027) and a higher rate of subcardial variceal bleeding compared with PPL group (7.7% v/s 0%, p=0.027). Serious adverse events related to EVL occurred in 2 patients, including 1 death. CONCLUSIONS: The present study supports that PPL should be considered the first choice in primary prophylaxis of variceal bleeding offering similar effects and lower severe adverse events compared with EVL.

Primary study

Unclassified

A randomized study comparing ligation with propranolol for primary prophylaxis of variceal bleeding in candidates for liver transplantation.

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Journal Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society
Year 2007
Links Pubmed Health Technology Assessment (HTA) DOI crd.york.ac.uk

This article is included in 4 Systematic reviews Systematic reviews (4 references) 1 Broad synthesis Broad syntheses (1 reference)

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Whether beta-blockers (BB) or banding is the best therapy for primary prophylaxis of variceal bleeding is subject to debate. A randomized comparison between the 2 treatments was performed in candidates for liver transplantation (LT). A total of 62 patients with Child-Turcotte-Pugh B-C cirrhosis and high risk varices received propranolol (31) or variceal banding (31). The primary endpoint was variceal bleeding. There were 2 variceal hemorrhages (6.5%) in the banding group, related to postbanding ulcers, and 3 (9.7%) in the propranolol group (P = not significant [n.s.]). Deaths and bleeding related deaths were 3 and 1 for banding and 3 and 2 for BB, respectively (P = n.s.). A total of 14 patients underwent LT in the banding group and 10 in the propranolol group (P = n.s.). Adverse events were 2 postbanding ulcer bleedings in ligated patients (1 fatal) and 5 were intolerant to propranolol (P = n.s.). Mean costs per patient were higher with banding than with propranolol treatment (4,289 +/- 285 vs. 1,425 +/- 460 U.S. dollars, P < 0.001). In conclusion, propranolol and banding are similarly effective in reducing the incidence of variceal bleeding in candidates for LT, but ligation can be complicated by fatal bleeding and is more expensive. Our results suggest that banding should not be utilized as primary prophylaxis in transplant candidates who can be treated with BB.

Primary study

Unclassified

Endoscopic variceal ligation versus pharmacologic treatment for primary prophylaxis of variceal bleeding: a randomised study

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Journal Journal of Hepatology
Year 2006
Links DOI

This article is included in 4 Systematic reviews Systematic reviews (4 references) 1 Broad synthesis Broad syntheses (1 reference)

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BACKGROUND AND AIM: Bleeding varices is a major complication of liver cirrhosis; 30 70% may die from the effect of the first bleed. Primary prophylax~is is therefore an important therapeutic goal. The aim of this study is to compare Endoscopic Variceal Ligation (EVL) with medical treatment for the prevention of the first episode of variceal bleeding. METHODS: 156 cirrhotic patients with risky varices were prospectively randomized to receive either EVL (51 patients), propranolol (52 patients) or Isosorbid-5-Mono-Nitrate (ISMN) (53 patients). And follow-up for 18 24 months for bleeding episodes and or mortality. RESULTS: There was no statistically significant difference between the 3 groups as regard sex, age, Child score, etiology of cirrhosis and grade of varices. Bleeding occurred in 4 (7.5%) in EVL group, 18 (34.6%) in ISMN group and 13 (25.5%) in propranolol group. There was no difference in mortality when the 3 groups were compared (7.5% vs 11.5% vs 9.8%), P 0.78. Complications or side effects were reported in 28.3% in EVL compared to 34.6% with ISMN and 39.2% for propranolol. CONCLUSION: In patients with high risk esophageal varices, EVL is more effective and safer than propranolol which is more effective than ISMN for primary prophylaxis of variceal bleeding.

Primary study

Unclassified

Endoscopic variceal ligation versus propranolol in prophylaxis of first variceal bleeding in patients with cirrhosis.

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Authors Lay CS , Tsai YT , Lee FY , Lai YL , Yu CJ , Chen CB , Peng CY
Journal Journal of gastroenterology and hepatology
Year 2006
Links Pubmed DOI

This article is included in 6 Systematic reviews Systematic reviews (6 references) 1 Broad synthesis Broad syntheses (1 reference)

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BACKGROUND AND AIM: To compare the efficacy and safety of endoscopic variceal ligation (EVL) with propranolol in prophylaxis on the rate of first esophageal variceal bleeding in patients with cirrhosis. METHODS: A prospective, randomized trial was conducted in 100 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. RESULTS: Life-table curves showed that prophylactic EVL and propranolol were similarly effective for primary prophylaxis of variceal bleeding (11/50 [22%]vs 12/50 [24%]; P = 0.68) and overall mortality (14/50 [28%]vs 12/50 [24%]; P = 0.49). The 2-year cumulative bleeding rate was 18% (9/50) in the EVL group and 16% (8/50) in the propranolol group. The 2-year cumulative mortality rate was 28% (14/50) in the EVL group and 24% (12/50) in the propranolol group. Comparison of Kaplan-Meier estimates of the time to death of both groups showed no significant difference in mortality in both groups (P = 0.86). Patients undergoing EVL had few treatment failures and died mainly of hepatic failure. In the propranolol group, the mean daily dosage of the drug was 68.2 +/- 32.8 mg, which was sufficient to reduce the pulse rate by 25%. 20% of patients withdrew from propranolol treatment due to adverse events. CONCLUSIONS: Prophylaxis EVL is as effective and as safe as treatment with propranolol in decreasing the incidence of first variceal bleeding and death in cirrhotic patients with high-risk esophageal varices.

Publication Thread

Jutbha R, Jensen DM, Martin P, et al, Jutabha R

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Primary study

Unclassified

A randomized controlled trial of beta-blockers versus endoscopic band ligation for primary prophylaxis: a large sample size is required to show a difference in bleeding rates.

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Journal Digestive diseases and sciences
Year 2005
Links Pubmed DOI

This article is included in 5 Systematic reviews Systematic reviews (5 references) 1 Broad synthesis Broad syntheses (1 reference)

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Primary prophylaxis with nonselective beta-blockers in high-risk subjects has been shown to be effective in reducing both esophageal variceal bleeding and mortality. Recently it has been suggested that band ligation may be a better option for primary prophylaxis. We compared nonselective beta-blockers with band ligation in patients with large varices (F2, F3) and elevated hepatic venous wedge pressure gradient (HVWPG, > or = 12 mm Hg). All patients were prospectively followed for variceal bleeding, mortality, and treatment-related complications. Based on previous published studies, we estimated that 90 patients in each arm would be required to show a difference in bleeding rate. The study was prematurely terminated when we realized that our estimated sample size was inadequate to show a difference based on the observed bleeding rate. At the time of termination, 31 patients (Child A, 11; B, 14; C, 6), with a mean HVWPG of 19 +/- 9.1 mm Hg, were randomized to either band ligation (group A; n = 16) or beta-blockers (group B; n = 15). Baseline demographics of both groups were similar and the mean follow-up period was 27.4 +/- 12.9 months. During the follow-up, two patients in group A and one patient in group B had bleeding. Nine patients (29%; group A, six; group B, three; P = ns) died due to non-bleeding-related causes and five (16%) patients (group A, three; group B, two) underwent liver transplantation. Treatment-related complication were minimal in both groups. Despite the selection of high-risk patients, the observed bleeding rate was much lower than anticipated. Based on our observed bleeding rates, 424 patients would be required in each arm to show a difference between band ligation and beta-blocker therapy.

Primary study

Unclassified

Endoscopic variceal ligation vs. propranolol for prevention of first variceal bleeding: a randomized controlled trial.

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Journal European journal of gastroenterology & hepatology
Year 2005
Links Pubmed DOI

This article is included in 6 Systematic reviews Systematic reviews (6 references) 1 Broad synthesis Broad syntheses (1 reference)

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<b>OBJECTIVES: </b>Data in the literature regarding the role of endoscopic variceal ligation for the prevention of first variceal bleeding in cirrhotic patients are controversial. To further explore this issue we have compared ligation and propranolol treatment in a prospective randomized study.<b>METHODS: </b>Sixty patients with cirrhosis and oesophageal varices with no history but at high risk of bleeding were randomized to ligation treatment (30 patients) or propranolol (30 patients). Patients were followed for approximately 27.5 months.<b>RESULTS: </b>Variceal obliteration was achieved in 28 patients (93.3%) after 3+/-1 sessions. The mean daily dose of propranolol was 60.3+/-13.3 mg. Two patients (6.7%) in the ligation group and nine patients (30%) in the propranolol group developed variceal bleeding (P = 0.043). The actuarial risks of variceal bleeding at 2 years were 6.7% and 25%, respectively. On multivariate analysis, propranolol treatment and grade III varices turned out to be predictive factors for the risk of variceal bleeding. Mortality was not different between the two groups. There were no serious complications due to ligation. Propranolol treatment was discontinued in four patients because of side effects.<b>CONCLUSIONS: </b>Variceal ligation is a safe and more effective method than propranolol treatment for the prevention of first variceal bleeding in cirrhotic patients with high-risk varices.

Publication Thread

Schepke, Michael, Schepke M

This thread includes 2 references