Diclofenac sodium versus ceftazidime for preventing pancreatitis after endoscopic retrograde cholangiopancreatography: a prospective, randomized, controlled trial.
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).



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.



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.



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.



NCT 01784445.
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.
Goran
0000-0002-4758-1717
G
Hauser
Department of Emergency Medicine, Clinical Hospital Centre Rijeka, Rijeka, Croatia.
Ivana
I
Blažević
Department of Gastroenterology and Hepatology, University Clinical Centre Tuzla, Tuzla, Bosnia and Herzegovina.
Nermin
N
Salkić
Department of Gastroenterology, Clinical Hospital Centre Rijeka, Krešimirova 42, Rijeka, 51000, Croatia.|Faculty of Medicine Rijeka, University of Rijeka, Rijeka, Croatia.
Goran
G
Poropat
Department of Gastroenterology, Clinical Hospital Centre Rijeka, Krešimirova 42, Rijeka, 51000, Croatia.|Faculty of Medicine Rijeka, University of Rijeka, Rijeka, Croatia.
Vanja
V
Giljača
Department of Gastroenterology, Clinical Hospital Centre Rijeka, Krešimirova 42, Rijeka, 51000, Croatia.|Faculty of Medicine Rijeka, University of Rijeka, Rijeka, Croatia.
Zlatko
Z
Bulić
Department of Gastroenterology, Clinical Hospital Centre Rijeka, Krešimirova 42, Rijeka, 51000, Croatia.|Faculty of Medicine Rijeka, University of Rijeka, Rijeka, Croatia.
Davor
D
Štimac
D015746:Abdominal Pain / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D061605:Administration, Intravenous; D000285:Administration, Rectal; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D002442:Ceftazidime / Q000627:therapeutic use*; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects; D004008:Diclofenac / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D011446:Prospective Studies; D055815:Young Adult
D000900:Anti-Bacterial Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal; D004008:Diclofenac; D002442:Ceftazidime
Anti-inflammatory agents; ERCP; Nonsteroidal; Pancreatitis