Prophylaxis of ERCP-related pancreatitis: A randomized, controlled trial of somatostatin and gabexate mesylate

Angelo Andriulli, Luigi Solmi, Silvano Loperfido, Pietro Leo, Virginia Festa, Angelo Belmonte, Fulvio Spirito, Michele Silla, Giovambattista Forte, Vittorio Terruzzi, Giorgio Marenco, Enrico Ciliberto, Antonio Sabatino, Fabio Monica, Maria Rita Magnolia, Francesco Perri

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Abstract

Background & Aims: It still is debated whether post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis can be prevented by administering either somatostatin or gabexate mesylate. The aim of the study is to assess the efficacy of a 6.5-hour infusion of somatostatin or gabexate mesylate in preventing ERCP-related complications. Methods: In a double-blind multicenter trial, 1127 patients undergoing ERCP were randomly assigned to intravenous administration of somatostatin (750 μg; n = 351), gabexate mesylate (500 mg; n = 381), or placebo (saline; n = 395). The drug infusion started 30 minutes before and continued for 6 hours after endoscopy. Patients were evaluated clinically, and serum amylase levels were determined at 4, 24, and 48 hours after endoscopy. Results: No significant differences in incidences of pancreatitis, hyperamylasemia, or abdominal pain were observed among the placebo (4.8%, 32.6%, and 5.3%, respectively), somatostatin (6.3%, 26.8%, and 5.1%, respectively), and gabexate mesylate groups (5.8%, 31.5%, and 6.3%, respectively). Univariate analysis of patient characteristics and endoscopic maneuvers showed that a Freeman score >1 (P <0.0001), ≥3 pancreatic injections (P <0.00001), and precut sphincterotomy (P = 0.01) were significantly associated with post-ERCP pancreatitis. At multiple logistic regression analysis, ≥3 pancreatic injections (odds ratio [OR], 1.95; 95% confidence interval [CI], 1.45-2.63) and a Freeman score >1 (OR, 1.47; 95% CI, 1.11-1.94) retained their predictive power. Conclusions: Long-term (6.5-hr) administration of either somatostatin or gabexate mesylate is ineffective for the prevention of post-ERCP pancreatitis. Pancreatic injury seems to be related to difficulty in common bile duct access.

Original languageEnglish
Pages (from-to)713-718
Number of pages6
JournalClinical Gastroenterology and Hepatology
Volume2
Issue number8
DOIs
Publication statusPublished - Aug 2004

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Keywords

  • CI
  • confidence interval
  • endoscopic retrograde cholangiopancreatography
  • ERCP
  • GIPPA
  • Italian Group for Prevention of Acute Pancreatitis
  • odds ratio
  • OR

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Andriulli, A., Solmi, L., Loperfido, S., Leo, P., Festa, V., Belmonte, A., Spirito, F., Silla, M., Forte, G., Terruzzi, V., Marenco, G., Ciliberto, E., Sabatino, A., Monica, F., Magnolia, M. R., & Perri, F. (2004). Prophylaxis of ERCP-related pancreatitis: A randomized, controlled trial of somatostatin and gabexate mesylate. Clinical Gastroenterology and Hepatology, 2(8), 713-718. https://doi.org/10.1016/S1542-3565(04)00295-2