Prophylactic somatostatin can reduce incidence of post-ERCP pancreatitis: multicenter randomized controlled trial.
Endoscopy
; 47(5): 415-20, 2015 May.
Article
em En
| MEDLINE
| ID: mdl-25590178
ABSTRACT
BACKGROUND AND STUDY AIM:
Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) remains the most common complication of ERCP. Somatostatin may inhibit pancreatic secretion and has been tested for PEP prophylaxis. However, the results of previous studies are inconsistent. The aim of the current study was to investigate whether somatostatin can reduce the incidence of PEP. PATIENTS ANDMETHODS:
The study was a multicenter, open-label, randomized controlled trial. A total of 908 patients with normal amylase levels who were undergoing ERCP were randomized to receive somatostatin 250âµg bolus injection before ERCP and 250âµg/hour intravenous infusion for 11 hours after ERCP (somatostatin group) or no somatostatin treatments (control group). The incidences of PEP and hyperamylasemia were compared in the two groups.RESULTS:
The full analysis set included 900 patients (445 in the somatostatin group, 455 in the control group). PEP developed in 34 patients (7.5â%) in the control group (95â% confidence interval [CI] 5.4â%â-â10.3â%) and in 18 patients (4.0â%) in the somatostatin group (95â%CI 2.6â%â-â6.3â%; Pâ=â0.03). Hyperamylasemia occurred in 46 patients (10.1â%) in the control group (95â%CI 7.7â%â-â13.2â%) and in 27 patients (6.1â%) in the somatostatin group (95â%CI 4.2â%â-â8.7â%; Pâ=â0.03). No perforation or death occurred during the study.CONCLUSIONS:
This study showed that somatostatin was effective and safe for the prevention of PEP and hyperamylasemia in ERCP patients.(ClinicalTrials.gov number, NCT01431781).
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Pancreatite
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Somatostatina
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Colangiopancreatografia Retrógrada Endoscópica
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Hormônios
Tipo de estudo:
Clinical_trials
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Etiology_studies
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Incidence_studies
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Risk_factors_studies
Limite:
Adult
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Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2015
Tipo de documento:
Article