EVL (Endoscopic Variceal Ligation) Plus Vasoconstrictor vs.Ligation Plus PPI( Proton Pump Inhibitor) in the Control of Acute Esophageal Variceal Bleeding
Condition: Esophageal Varices; Bleeding
MeSH terms: Esophageal and Gastric Varices; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      Previous studies showed that combination of endoscopic therapy with vasoconstrictor is better
      than either vasoconstrictor or endoscopic therapy alone in achieving the successful
      hemostatsis of acute variceal bleeding. The rationale of using vasoconstrictor is to enhance
      the efficacy of hemostasis by endoscopic therapy. Nowadays, endoscopic variceal ligation
      (EVL) has replaced endoscopic injection sclerotherapy (EIS) as the endoscopic treatment of
      choice in the arresting of acute esophageal variceal hemorrhage. EVL alone can achieve
      hemotasis up to 97% even in cases of active variceal hemorrhage. However, early rebleeding
      due to ligation-induced ulcer may be encountered. It appears that prevention of esophageal
      ulcers and bleeding by a proton pump inhibitor may be more logical than using a
      vasoconstrictor after cessation of bleeding by EVL.
    

Detailed description: 
      Previous studies showed that combination of endoscopic therapy with vasoconstrictor is better
      than either vasoconstrictor or endoscopic therapy alone in achieving the successful
      hemostatsis of acute variceal bleeding. The rationale of using vasoconstrictor is to enhance
      the efficacy of hemostasis by endoscopic therapy. Nowadays, endoscopic variceal ligation
      (EVL) has replaced endoscopic injection sclerotherapy (EIS) as the endoscopic treatment of
      choice in the arresting of acute esophageal variceal hemorrhage. EVL alone can achieve
      hemotasis up to 97% even in cases of active variceal hemorrhage. However, early rebleeding
      due to ligation-induced ulcer may be encountered. It appears that prevention of esophageal
      ulcers and bleeding by a proton pump inhibitor may be more logical than using a
      vasoconstrictor after cessation of bleeding by EVL.

      Thus, we designed a controlled trial to compare the initial hemostasis, early rebleeding rate
      in cirrhotic patients presenting with acute variceal bleeding receiving either emergency EVL
      plus somatostatin infusion or losec infusion for 5 days.

      AIMS:

      To investigate whether the combination of EVL and somatostatin is superior to the combination
      of EVL and losec in terms of efficacy in the arresting of acute esophageal variceal bleeding
      and very early rebleeding.
    

Intervention name(s): pantoloc 40 mg; somatostatin or terlipressin
Intervention type(s): Drug; Drug
Intervention description(s): pantoloc iv. infusion per day; Somatostatin 6mg in 500 cc 5% dextrose, 250μg slow bolus IV infusion followed by 250μg per hour (6mg/ 24 hours) or Terlipressin 2mg bolus was instituted on enrollment followed by 1mg per 6 hours for 5 days. The use of either somatostatin or glypressin was at the discretion of doctors in charge.
Other intervention name(s): pantoloc, a proton pump inhibitor; somatostatin and terlipressin are vasoconstrictors.
Intervention MeSH terms: Terlipressin; Vasoconstrictor Agents; Proton Pump Inhibitors; Somatostatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: control of bleed