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Diclofenac sodium versus ceftazidime for preventing pancreatitis after endoscopic retrograde cholangiopancreatography: a prospective, randomized, controlled trial.
Surg Endosc. 2017 02; 31(2):602-610.SE

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.

Authors+Show Affiliations

Department of Gastroenterology, Clinical Hospital Centre Rijeka, Krešimirova 42, Rijeka, 51000, Croatia. goran.hauser@medri.uniri.hr. Faculty of Medicine Rijeka, University of Rijeka, Rijeka, Croatia. goran.hauser@medri.uniri.hr. Faculty of Health Studies, University of Rijeka, Rijeka, Croatia. goran.hauser@medri.uniri.hr.Department of Emergency Medicine, Clinical Hospital Centre Rijeka, Rijeka, Croatia.Department of Gastroenterology and Hepatology, University Clinical Centre Tuzla, Tuzla, Bosnia and Herzegovina.Department of Gastroenterology, Clinical Hospital Centre Rijeka, Krešimirova 42, Rijeka, 51000, Croatia. Faculty of Medicine Rijeka, University of Rijeka, Rijeka, Croatia.Department of Gastroenterology, Clinical Hospital Centre Rijeka, Krešimirova 42, Rijeka, 51000, Croatia. Faculty of Medicine Rijeka, University of Rijeka, Rijeka, Croatia.Department of Gastroenterology, Clinical Hospital Centre Rijeka, Krešimirova 42, Rijeka, 51000, Croatia. Faculty of Medicine Rijeka, University of Rijeka, Rijeka, Croatia.Department of Gastroenterology, Clinical Hospital Centre Rijeka, Krešimirova 42, Rijeka, 51000, Croatia. Faculty of Medicine Rijeka, University of Rijeka, Rijeka, Croatia.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

27317032

Citation

Hauser, Goran, et al. "Diclofenac Sodium Versus Ceftazidime for Preventing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography: a Prospective, Randomized, Controlled Trial." Surgical Endoscopy, vol. 31, no. 2, 2017, pp. 602-610.
Hauser G, Blažević I, Salkić N, et al. Diclofenac sodium versus ceftazidime for preventing pancreatitis after endoscopic retrograde cholangiopancreatography: a prospective, randomized, controlled trial. Surg Endosc. 2017;31(2):602-610.
Hauser, G., Blažević, I., Salkić, N., Poropat, G., Giljača, V., Bulić, Z., & Štimac, D. (2017). Diclofenac sodium versus ceftazidime for preventing pancreatitis after endoscopic retrograde cholangiopancreatography: a prospective, randomized, controlled trial. Surgical Endoscopy, 31(2), 602-610. https://doi.org/10.1007/s00464-016-5004-9
Hauser G, et al. Diclofenac Sodium Versus Ceftazidime for Preventing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography: a Prospective, Randomized, Controlled Trial. Surg Endosc. 2017;31(2):602-610. PubMed PMID: 27317032.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Diclofenac sodium versus ceftazidime for preventing pancreatitis after endoscopic retrograde cholangiopancreatography: a prospective, randomized, controlled trial. AU - Hauser,Goran, AU - Blažević,Ivana, AU - Salkić,Nermin, AU - Poropat,Goran, AU - Giljača,Vanja, AU - Bulić,Zlatko, AU - Štimac,Davor, Y1 - 2016/06/17/ PY - 2016/02/29/received PY - 2016/05/23/accepted PY - 2016/11/5/pubmed PY - 2019/3/21/medline PY - 2016/6/19/entrez KW - Anti-inflammatory agents KW - ERCP KW - Nonsteroidal KW - Pancreatitis SP - 602 EP - 610 JF - Surgical endoscopy JO - Surg Endosc VL - 31 IS - 2 N2 - 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. SN - 1432-2218 UR - https://www.unboundmedicine.com/medline/citation/27317032/Diclofenac_sodium_versus_ceftazidime_for_preventing_pancreatitis_after_endoscopic_retrograde_cholangiopancreatography:_a_prospective_randomized_controlled_trial_ L2 - https://dx.doi.org/10.1007/s00464-016-5004-9 DB - PRIME DP - Unbound Medicine ER -