Efficacy of Octreotide Versus Terlipressin along with Endoscopic Variceal Ligation (EVL) in Preventing Re-bleeding and Mortality in Acute Bleeding Esophageal Varices in Cirrhosis: A Randomized Prospective Study

Background: Octreotide and terlipressin are two pharmacologic drugs used as an adjuvant therapy in the treatment of acute esophageal variceal bleeding. Large enough clinical trial data is not available, in comparing the efficacy of octreotide versus terlipressin as an adjunct to EVL for control of variceal bleed. Still, there is a scarcity of data on which is the better efficient drug amongst terlipress in and octreotide to control 5 days rebleeding.

Aim: To compare efficacy of octreotide versus terlipressin in preventing the 6 weeks mortality (primary outcome) and 5 days rebleeding (secondary outcome) in cases of acute esophageal variceal bleeding.

Method: All the patients of cirrhosis of liver presenting with upper gastrointestinal bleeding admitted in the Medicine Intensive Care Unit(MICU) at Acharya Vinoba Bhave Rural Hospital (AVBRH) will be enrolled. In this Randomized Prospective study ,patients presenting with acute esophageal variceal bleed, after diagnostic endoscopy during a period of one year (august 2020 to july 2021) will be randomised into two group by simple randomisation with chits: Group A will receive Terlipressin while Group B will receive Octreotide for 5 days combined with esophageal variceal ligation. These two groups will be compared in terms of hemodynamic effects, child pugh score, MELD (Model for End stage Liver Disease) score to predict 6 weeks mortality as primary outcome and 5 day treatment failure as secondary outcome according to Bavino VI consensus statement.

Expected results: From our study we are anticipating that both octreotide and terlipressin will be equally efficacious in controlling the EVB when given along with EVL therapy and also there will be no difference in both the drugs in preventing 6 weeks mortality and 5 days rebleeding.

Conclusion: There will be no significant difference between Terlipressin and Octreotide in preventing 6 week mortality and 5 day rebleeding in bleeding esophageal varices when given along with EVL therapy.