Prophylaxis of ERCP-related pancreatitis: A randomized, controlled trial of somatostatin and gabexate mesylate1 1The trial was designed and the manuscript was written by Dr. Andriulli. No pharmaceutical or private grants were searched for or made available for performing the present work
| Autor: | Giovambattista Forte, Angelo Andriulli, Vittorio Terruzzi, Virginia Festa, Maria Rita Magnolia, Francesco Perri, Fabio Monica, Pietro Leo, Enrico Ciliberto, Angelo Belmonte, Michele Silla, Fulvio Spirito, L. Solmi, Giorgio Marenco, Silvano Loperfido, Antonio Di Sabatino |
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| Rok vydání: | 2004 |
| Předmět: |
medicine.medical_specialty
Abdominal pain Univariate analysis Endoscopic retrograde cholangiopancreatography Hepatology medicine.diagnostic_test business.industry Gastroenterology medicine.disease Placebo Somatostatin Internal medicine Multicenter trial medicine Pancreatitis Pancreatic injury medicine.symptom business |
| Zdroj: | Clinical Gastroenterology and Hepatology. 2:713-718 |
| ISSN: | 1542-3565 |
| DOI: | 10.1016/s1542-3565(04)00295-2 |
| Popis: | 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 P 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. |
| Databáze: | OpenAIRE |
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