| Gabexate or somatostatin administration before ERCP in patients at high risk for post-ERCP pancreatitis: a multicenter, placebo-controlled, randomized clinical trial. | |
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MedLine Citation:
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PMID: 12297762 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: ERCP is frequently complicated by pancreatitis. The aims of this study were to assess the efficacy of somatostatin and gabexate for prevention of post-ERCP pancreatitis in high-risk patients and to determine predisposing factors for post-ERCP pancreatitis. A meta-analysis was conducted of all published studies on the use of somatostatin or gabexate for prevention of post-ERCP pancreatitis. METHODS: A double blind, multicenter, placebo-controlled trial was conducted in patients at high risk for post-ERCP pancreatitis. Patients were randomized to receive an intravenous infusion of somatostatin (750 mg), gabexate (500 mg), or placebo that was started 30 minutes before endoscopy and continued for 2 hours afterward. Patients were evaluated clinically and serum amylase levels determined at 4 and 24 hours after endoscopy. RESULTS: No significant difference in the occurrence of pancreatitis, hyperamylasemia, or abdominal pain was observed among placebo-, gabexate-, and somatostatin-treated patients. A sphincterotomy longer than 2 cm (p = 0.0001), more than 3 pancreatic injections (p = 0.0001), and unsuccessful cannulation (p = 0.008) were predictive of post-ERCP pancreatitis. Hyperamylasemia was predicted by more than 3 pancreatic injections (p = 0.0001) and sphincterotomy (p = 0.02). The meta-analysis of trials of short-term infusion of gabexate or somatostatin did not show efficacy for either drug. CONCLUSIONS: Short-term administration of gabexate or somatostatin in patients at high risk for pancreatitis is ineffective for prevention of ERCP-induced pancreatitis. Pancreatic injury is related to maneuvers used to obtain biliary access rather than to any patient characteristic or endoscopist experience. |
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Authors:
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Angelo Andriulli; Rocco Clemente; Luigi Solmi; Vittorio Terruzzi; Renzo Suriani; Angelo Sigillito; Gioacchino Leandro; Pietro Leo; Giovanni De Maio; Francesco Perri |
Publication Detail:
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Type: Clinical Trial; Comparative Study; Evaluation Studies; Journal Article; Meta-Analysis; Multicenter Study; Randomized Controlled Trial |
Journal Detail:
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Title: Gastrointestinal endoscopy Volume: 56 ISSN: 0016-5107 ISO Abbreviation: Gastrointest. Endosc. Publication Date: 2002 Oct |
Date Detail:
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Created Date: 2002-09-25 Completed Date: 2002-12-03 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 0010505 Medline TA: Gastrointest Endosc Country: United States |
Other Details:
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Languages: eng Pagination: 488-95 Citation Subset: IM |
Affiliation:
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Casa Sollievo della Sofferenza Hospital, IRCCS, San Giovanni Rotondo, Italy. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Acute Disease Adult Cholangiopancreatography, Endoscopic Retrograde / adverse effects* Clinical Competence Double-Blind Method Female Gabexate / therapeutic use* Hormones / therapeutic use* Humans Hyperamylasemia / blood Male Meta-Analysis as Topic Middle Aged Pancreatitis / etiology*, prevention & control* Placebo Effect Preoperative Care / methods* Prospective Studies Risk Factors Serine Proteinase Inhibitors / therapeutic use* Somatostatin / therapeutic use* Sphincterotomy, Endoscopic Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Hormones; 0/Serine Proteinase Inhibitors; 39492-01-8/Gabexate; 51110-01-1/Somatostatin |
| Comments/Corrections | |
Comment In:
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Gastrointest Endosc. 2003 Nov;58(5):816
[PMID:
14997914
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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