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

ABSTRACT: BACKGROUND: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 NCT01267669.

SUBMITTER: Kumar A

PROVIDER: S-EPMC4632096 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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

Kumar Ashish A Kumar Ashish A Jha Sanjeev K SK Mittal Vibhu V VV Sharma Praveen P Sharma Barjesh C BC Sarin Shiv K SK

Journal of clinical and experimental hepatology 20150616 3

<h4>Background</h4>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.<h4>Methods</h4>Consecutive cirrhotic patients with acute esophageal variceal bleeding were enrolled. ...[more]

PMID: 26628838

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Project description:BackgroundEndoscopic treatment is recommended for the management of esophageal varices. However, variceal recurrence or rebleeding is common after endoscopic variceal eradication. Our study aimed to systematically evaluate the prevalence of esophageal collateral veins (ECVs) and the association of ECVs with recurrence of esophageal varices or rebleeding from esophageal varices after endoscopic treatment.MethodsWe searched the relevant literature through the PubMed, EMBASE, and Cochrane Library databases. Prevalence of paraesophageal veins (para-EVs), periesophageal veins (peri-EVs), and perforating veins (PVs) were pooled. Risk ratio (RR) and odds ratio (OR) with 95% confidence intervals (CIs) were calculated for cohort studies and case-control studies, respectively. A random-effects model was employed. Heterogeneity among studies was calculated.ResultsAmong the 532 retrieved papers, 28 were included. The pooled prevalence of para-EVs, peri-EVs, and PVs in patients with esophageal varices was 73%, 88%, and 54%, respectively. The pooled prevalence of para-EVs and PVs in patients with recurrence of esophageal varices was 87% and 62%, respectively. The risk for recurrence of esophageal varices was significantly increased in patients with PVs (OR = 9.79, 95% CI: 1.95-49.22, P = 0.006 for eight case-control studies), but not in those with para-EVs (OR = 4.26, 95% CI: 0.38-38.35, P = 0.24 for four case-control studies; RR = 1.81, 95% CI: 0.83-3.97, P = 0.14 for three cohort studies). Patients with para-EVs had a significantly higher incidence of rebleeding from esophageal varices (RR = 13.00, 95% CI: 2.43-69.56, P = 0.003 for two cohort studies). Statistically significant heterogeneity was notable across the meta-analyses.ConclusionsECVs are common in patients with esophageal varices. Identification of ECVs could be helpful for predicting the recurrence of esophageal varices or rebleeding from esophageal varices after endoscopic treatment.

Project description:BackgroundGlobal research on endoscopic therapies in combination with partial splenic embolization (PSE) for variceal hemorrhage (VH) is limited. Therefore, we aimed to evaluate the efficacy and safety of endoscopy plus PSE (EP) treatment in comparison to endoscopic (E) treatment for the secondary prophylaxis of VH in cirrhosis patients with hypersplenism.MethodsCirrhosis patients with hypersplenism (platelet count < 100, 000/µL) and those who had recovered from an episode of VH were enrolled in a multicenter randomized controlled trial. The participants were randomly assigned into EP and E groups in a 1:1 ratio. The primary endpoint was variceal rebleeding, and the secondary endpoints were severe variceal recurrence and mortality during the 2-year follow-up. Hematological indices, serum biochemical parameters, and the Child-Pugh score were measured at each time point.ResultsFrom June 2016 to December 2019, 108 patients were enrolled in the study, among which 102 patients completed the protocol (51 in EP and 51 in E group). The rebleeding rate of the varices was significantly reduced in the EP group compared to that in the E group during the 2 years (16% vs. 31%, p < 0.001). The EP group showed a significantly lower variceal recurrence rate than the E group (22% vs. 67%, p < 0.001). The COX proportional hazard models revealed that grouping was an independent predictor for variceal rebleeding (H = 0.122, 95% CI 0.055-0.270, p < 0.001) and variceal recurrence (hazard ratio, H = 0.160, 95% CI 0.077-0.332, p < 0.001). The peripheral blood cell count, Child-Pugh class/score, albumin concentration, and coagulation function in the EP group improved significantly compared to the values observed in the E group at any time point (p < 0.05).ConclusionsThe EP treatment was more effective in preventing variceal rebleeding and variceal recurrence than the conventional E treatment during the secondary prophylaxis of VH in cirrhosis patients with hypersplenism. Furthermore, the EP treatment could significantly increase the peripheral blood cell count and albumin concentration and also improved the coagulation function and the Child-Pugh score.Clinical trials registrationTrial registration number ClincialTrials.gov: NCT02778425. The URL of the clinical trial: https://clinicaltrials.gov/.

Dataset Information

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

Publications

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

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