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Pancreas
A randomised, double blind, multicentre trial of octreotide in moderate to severe acute pancreatitis
  1. W Uhla,
  2. M W Büchlera,
  3. P Malfertheinerb,
  4. H G Begerc,
  5. G Adlerc,
  6. W Gausd,
  7. the German Pancreatitis Study Group
  1. aDepartment of Visceral and Transplantation Surgery, University of Bern, Bern, Switzerland, bDepartment of Internal Medicine, University of Magdeburg, Magdeburg, Germany, cDepartment of General Surgery and Internal Medicine, University of Ulm, Ulm, Germany, dDepartment of Biometry and Medical Documentation, University of Ulm, Ulm, Germany
  1. Professor M W Büchler, Department of Visceral and Transplantation Surgery, University Hospital of Bern, Inselspital, CH-3010 Bern, Switzerland.

Abstract

BACKGROUND The pharmacological inhibition of exocrine pancreatic secretion with the somatostatin analogue octreotide has been advocated as a specific treatment of acute pancreatitis.

AIM To investigate the efficacy of octreotide in acute pancreatitis in a randomised, placebo controlled trial.

METHODS 302 patients from 32 hospitals, fulfilling the criteria for moderate to severe acute pancreatitis within 96 hours of the onset of symptoms, were randomly assigned to one of three treatment groups: group P (n=103) received placebo, while groups O1 (n=98) and O2 (n=101) received 100 and 200 μg of octreotide, respectively, by subcutaneous injection three times daily for seven days. The primary outcome variable was a score composed of mortality and 15 typical complications of acute pancreatitis.

RESULTS The three groups were well matched with respect to pretreatment characteristics. An intent to treat analysis of all 302 patients revealed no significant differences among treatment groups with respect to mortality (P: 16%; O1: 15%; O2: 12%), the rate of newly developed complications, the duration of pain, surgical interventions, or the length of the hospital stay. A valid for efficacy analysis (251 patients) also revealed no significant differences.

CONCLUSIONS This trial shows no benefit of octreotide in the treatment of acute pancreatitis.

  • acute pancreatitis
  • somatostatin
  • octreotide
  • randomised controlled multicentre trial

  • Abbreviations used in this paper

    ARDS
    adult respiratory distress syndrome
    CRF
    case report form
    CT
    contrast enhanced computed tomography
    ERCP
    endoscopic retrograde cholangiopancreatography
    ITT
    intent to treat
    O
    octreotide
    P
    placebo
    RCT
    randomised controlled trial
    SIRS
    systemic inflammatory response syndrome
    VFE
    valid for efficacy

    • https://doi.org/10.1136/gut.45.1.97

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    • Abbreviations used in this paper

      ARDS
      adult respiratory distress syndrome
      CRF
      case report form
      CT
      contrast enhanced computed tomography
      ERCP
      endoscopic retrograde cholangiopancreatography
      ITT
      intent to treat
      O
      octreotide
      P
      placebo
      RCT
      randomised controlled trial
      SIRS
      systemic inflammatory response syndrome
      VFE
      valid for efficacy
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