Goran Hauser1,2,3, Ivana Blažević4, Nermin Salkić5, Goran Poropat6,7, Vanja Giljača6,7, Zlatko Bulić6,7, Davor Štimac6,7. 1. Department of Gastroenterology, Clinical Hospital Centre Rijeka, Krešimirova 42, Rijeka, 51000, Croatia. goran.hauser@medri.uniri.hr. 2. Faculty of Medicine Rijeka, University of Rijeka, Rijeka, Croatia. goran.hauser@medri.uniri.hr. 3. Faculty of Health Studies, University of Rijeka, Rijeka, Croatia. goran.hauser@medri.uniri.hr. 4. Department of Emergency Medicine, Clinical Hospital Centre Rijeka, Rijeka, Croatia. 5. Department of Gastroenterology and Hepatology, University Clinical Centre Tuzla, Tuzla, Bosnia and Herzegovina. 6. Department of Gastroenterology, Clinical Hospital Centre Rijeka, Krešimirova 42, Rijeka, 51000, Croatia. 7. Faculty of Medicine Rijeka, University of Rijeka, Rijeka, Croatia.
Abstract
BACKGROUND AND AIMS: We aimed to compare the efficacy of prophylactic, parenterally administered ceftazidime and rectally applied diclofenac sodium for the prophylaxis of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). METHODS: We prospectively enrolled patients who underwent ERCP. In a double-blind, randomized, controlled trial, patients received a suppository containing diclofenac sodium rectally (100 mg) and placebo intravenously (group A) or ceftazidime intravenously (1 g) and placebo rectally (group B) immediately before the procedure. The serum and urine amylase levels were recorded and the patients were clinically evaluated after ERCP. RESULTS: Of the 272 patients enrolled (group A: 129; group B: 143), 32 developed pancreatitis (group A: 11 [8.5 %]; group B: 21 [14.7 %]; P = 0.17; relative risk = 1.72; 95 % confidence interval [CI] = 0.86-3.43). The severity of the pancreatitis or complications did not significantly differ between the groups. A serum amylase level of ≥560 U/L and urine amylase level of ≥1150 U/L indicated a positive likelihood ratio for post-ERCP pancreatitis of ≥10. Moreover, the threshold visual analog scale score of ≤5 for abdominal pain after ERCP had excellent diagnostic potential for predicting the presence or absence of post-ERCP pancreatitis. CONCLUSIONS: The PEP incidence did not differ between the ceftazidime and diclofenac sodium groups. In patients with nonsteroidal anti-inflammatory drug contraindications, antibiotics can be considered a safe alternative to diclofenac sodium for PEP prevention. Moreover, the visual analog scale for abdominal pain has excellent diagnostic value for predicting PEP. CLINICAL TRIALS. GOV NUMBER: NCT 01784445.
RCT Entities:
BACKGROUND AND AIMS: We aimed to compare the efficacy of prophylactic, parenterally administered ceftazidime and rectally applied diclofenac sodium for the prophylaxis of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). METHODS: We prospectively enrolled patients who underwent ERCP. In a double-blind, randomized, controlled trial, patients received a suppository containing diclofenac sodium rectally (100 mg) and placebo intravenously (group A) or ceftazidime intravenously (1 g) and placebo rectally (group B) immediately before the procedure. The serum and urine amylase levels were recorded and the patients were clinically evaluated after ERCP. RESULTS: Of the 272 patients enrolled (group A: 129; group B: 143), 32 developed pancreatitis (group A: 11 [8.5 %]; group B: 21 [14.7 %]; P = 0.17; relative risk = 1.72; 95 % confidence interval [CI] = 0.86-3.43). The severity of the pancreatitis or complications did not significantly differ between the groups. A serum amylase level of ≥560 U/L and urine amylase level of ≥1150 U/L indicated a positive likelihood ratio for post-ERCP pancreatitis of ≥10. Moreover, the threshold visual analog scale score of ≤5 for abdominal pain after ERCP had excellent diagnostic potential for predicting the presence or absence of post-ERCP pancreatitis. CONCLUSIONS: The PEP incidence did not differ between the ceftazidime and diclofenac sodium groups. In patients with nonsteroidal anti-inflammatory drug contraindications, antibiotics can be considered a safe alternative to diclofenac sodium for PEP prevention. Moreover, the visual analog scale for abdominal pain has excellent diagnostic value for predicting PEP. CLINICAL TRIALS. GOV NUMBER: NCT 01784445.
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