A Randomized, Controlled Trial of Ligation Plus Vasoconstrictor vs.Ligation Plus Proton Pump Inhibitor in the Control of Acute Esophageal Variceal Bleeding
Overview
- Phase
- Phase 4
- Intervention
- somatostatin or terlipressin
- Conditions
- Esophageal Varices
- Sponsor
- National Science Council, Taiwan
- Enrollment
- 118
- Primary Endpoint
- Success rate of initial hemostasis
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The etiology of portal hypertension is cirrhosis.
- •Age ranges between 18-80 y/o.
- •Patients presenting with acute esophageal variceal bleeding proven by emergency endoscopy within 12 hours. (Acute esophageal variceal bleeding was defined as: (1) when blood was directly seen by endoscopy to issue from an esophageal varix (active bleeding), or (2) when patients presented with red color signs on their esophageal varices with blood in esophagus or stomach and no other potential site of bleeding identified (inactive bleeding).
- •EVL is performed after confirmation of acute esophageal variceal bleeding. Enrollment time: Immediately after EVL is completed and variceal bleeding is arrested.
Exclusion Criteria
- •Association with severe systemic illness, such as sepsis, COPD, uremia
- •Association with gastric variceal bleeding
- •Failure in the control of bleeding by emergency EVL
- •Moribund patients, died within 12 hours of enrollment
- •Uncooperative
- •Ever received EIS, EVL within one month prior to index bleeding
- •Child-Pugh's scores \> 13
Arms & Interventions
EVL + vasoconstrictor
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.
Intervention: somatostatin or terlipressin
EVL + PPI
Pantoloc 40 mg intravenously per day was instituted on enrollment and continued for 5
Intervention: pantoloc 40 mg
Outcomes
Primary Outcomes
Success rate of initial hemostasis
Time Frame: 5 days
Definition of initial hemostasis Initial hemostasis was defined as achieving a 24h bleeding-free period within the first 48h after treatment together with stable vital signs based on Baveno consensus criteria. Very early rebleeding was defined as: UGI bleeding occurred after initial hemostasis and within 5 days after enrollment. UGI bleeding was proven to be from esophageal varices.
very early rebleeding
Time Frame: 48-120 hours after treatment
Very early rebleeding is defined as episodes of variceal bleeding 48-120 hours after treatment.
Secondary Outcomes
- The amount of blood transfusion within 42 days(42 days)
- Mortality(within 42 days)
- The size and number of ulcers on varices(2 weeks after treatment)