Impact of low-molecular-weight heparin in the treatment of moderately severe and severe acute pancreatitis; a randomized, single blind, phase 3 control trial

Abstract

Introduction: Acute pancreatitis is inflammation of pancreatic parenchyma which is an emergency condition. It is classified as mild, moderately severe, and severe categories. In severe acute pancreatitis, mortality is up to 10%-30%. Pancreatic abscess increases the mortality to 40%, and infected pancreatitis carries 100% mortality without surgical drainage. Anti-coagulant, anti-inflammatory and anti-protease activities of low-molecular-weight heparin are involved in preventing pancreatic necrosis and curbing the adverse outcomes of acute pancreatitis.

Aim: To determine the effect of low-molecular-weight heparin on the outcome of moderately severe and severe acute pancreatitis.

Materials and methodology: Hospital based, single centre, randomized, single blind, phase 3 control trial. First 140 patients with moderately severe and severe acute pancreatitis admitted in hospital in the given period who met the inclusion and exclusion criteria were taken. 70 patients were placed in the control and the trial group each by simple randomization (closed envelope method). The control group received conventional treatment for pancreatitis & the trial group received 1mg/kg body weight Enoxaperin, subcutaneously, 12 hourly for seven days along with the conventional treatment. Progression of disease in Computed Tomography Severity Index and incidence of pancreatic necrosis were the main outcomes studied at the end of 7 days of treatment.

Results: 1386 acute abdomen cases were screened, of which 269 were diagnosed with acute pancreatitis. 147 patients with acute pancreatitis met the selection criteria and 7 were dropouts. Recruitment started on April 9, 2021 and closed on December 5, 2021. Computed Tomography Severity Index progressed in 22(31.40%) patients in control group and 6(8.6%) patients in the trial group and 18(25.71%) in the control group and 4(5.71%) in the trial group showed the presence of necrosis. The differences are significant (P value is 0.001 in each). No adverse events were seen.

Conclusion: Use of low-molecular-weight heparin in early stage of moderately severe and severe acute pancreatitis significantly reduces the chance of disease progression and pancreatic necrosis.

Keywords: Acute pancreatitis; CT severity Index; Low-molecular-weight heparin; Pancreatic necrosis.