Short-course Somatostatin Versus Terlipressin Infusion in Combination With Endoscopic Variceal Ligation for the Prevention of Early Esophageal Variceal Rebleeding

Introduction Rupture of esophageal varices that results in variceal hemorrhage is a major complication of cirrhotic patient leading to high mortality rate. Despite the control of initial bleeding, the early rebleeding may be as high as 30-50% among the survived patients and the mortality rate be up to 40%. Therefore it is recommended that the goals should be placed at bleeding arrest and prevention of early rebleeding.

Vasoactive drugs may reduce portal hypertension which leads to a reduction in variceal pressure to achieve better control of hemorrhage. In general, vasoactive agents profoundly improve the control of variceal bleeding if compared to placebo. On the other hand, the efficacy of somatostatin for early rebleeding control is similar to terlipressin. In suspected acute variceal bleeding (EVB), vasoactive drugs should be started as soon as possible and are generally prescribed for 5 day to prevent against very early rebleeding. Endoscopic variceal ligation (EVL) is recommended in patients with EVB and is best used in combination with vasoactive drugs according to the Baveno IV consensus. In contrast to consensus recommendation, short-course administration (2-day or 3-day) of vasoactive drugs are as effective as a 5-day course for the control of acute EVB when used as an adjuvant therapy to EVL.

The management of acute EVB in real world clinical practice may be much different from the recommendation of guidelines. In Taiwan, the National Health Insurance (NHI) program uses a single-payer system, covers 99.9% of the nation's population and provides physicians with a high degree freedom in choosing various medications. Nevertheless, the NHI system to date provides only a short-course (3 days) administration of vasoactive drugs in treating acute EBV. This leads us to conduct this study, with the aim of this prospective cohort study to assess the efficacy and safety of 3-day somatostatin compared with 3-day terlipressin in acute EVB patient receiving EVL in real world situation in Taiwan. The preference of doctors towards vasoactive drugs and the efficacy of vasoactive agents in preventing rebleeding were analyzed.

Materials and Methods Study Patients From April 2010 through April 2015, cirrhotic patients admitted to Kaohsiung Veterans General Hospital (tertiary referral center) with significant upper gastrointestinal bleeding were screened. Eligible patients with acute EVB were non-randomly assigned to receive early administration of somatostatin (group S) or terlipressin (group T), followed by EVL within 24 hours.

Inclusion criteria were: (i) acute hemorrhage from esophageal varice(s); (ii) portal hypertension attributed by cirrhosis; (iii) age was between 20 and 80 years old. Acute bleeding of esophageal varices was defined as when oozing or spurting were directly observed endoscopically, or when red color signs and/or white nipple sign were seen on esophageal varices without other potential sources of bleeding identified.