Addition of Somatostatin After Successful Endoscopic Variceal Ligation Does not Prevent Early Rebleeding in Comparison to Placebo: A Double Blind Randomized Controlled Trial

详细信息    查看全文

• 作者：Ashish Kumar^* ; ^&dagger ; ; ^&Dagger ; ; ^{ashishk10@yahoo.com" class="auth_mail" title="E-mail the corresponding author} ; Sanjeev K. Jha^&dagger ; ; Vibhu V. Mittal^&dagger ; ; Praveen Sharma^* ; ^&dagger ; ; ^&Dagger ; ; Barjesh C. Sharma^&dagger ; ; Shiv K. Sarin^* ; ^&dagger ;
• 关键词：Variceal bleeding ; Endoscopic therapy ; Band ligation ; Octreotide ; Terlipressin
• 刊名：Journal of Clinical and Experimental Hepatology
• 出版年：2015
• 出版时间：September 2015
• 年：2015
• 卷：5
• 期：3
• 页码：204-212
• 全文大小：214 K

文摘

Efficacy of endoscopic sclerotherapy in controlling acute variceal bleeding is significantly improved when vasoactive drug is added. Endoscopic variceal ligation (EVL) is superior to sclerotherapy. Whether efficacy of EVL will also improve with addition of somatostatin is not known. We compared EVL plus somatostatin versus EVL plus placebo in control of acute variceal bleeding.

Methods

Consecutive cirrhotic patients with acute esophageal variceal bleeding were enrolled. After emergency EVL, patients were randomized to receive either somatostatin (250 mcg/hr) or placebo infusion. Primary endpoint was treatment failure within 5 days. Treatment failure was defined as fresh hematemesis ≥2 h after start of therapy, or a 3 gm drop in Hb, or death.

Results

61 patients were enrolled (EVL plus somatostatin group, n = 31 and EVL plus placebo group, n = 30). The baseline characteristics were similar. Within the initial 5-day period, the frequency of treatment failure was similar in both the groups (EVL plus somatostatin group 8/31 [26%] versus EVL plus placebo group 7/30 [23%]; P = 1.000). The mortality was also similar in the two groups (3/31 [10%] vs. 3/30 [10%]; P = 1.000). Baseline HVPG ≥19 mm Hg and active bleeding at index endoscopy were independent predictors of treatment failure.

Conclusions

Addition of somatostatin infusion to EVL therapy does not offer any advantage in control of acute variceal bleeding or reducing mortality. The reason for this may be its failure to maintain sustained reduction in portal pressure for five days. Active bleeding at index endoscopy and high baseline HVPG should help choose early alternative treatment options.

Trial registered with ClincalTrials.gov vide class="interref" data-locatorType="ctgov" data-locatorKey="NCT01267669%09">NCT01267669.