title: Combination of diclofenac plus somatostatin in the prevention of post-ERCP pancreatitis: a randomized, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  Pancreatitis is the most common complication of therapeutic endoscopic retrograde cholangiopancreatography (ERCP), and many pharmacoprophylactic approaches have been suggested, though not without controversy. The aim was to investigate the impact of combined therapy with diclofenac plus somatostatin on reducing the frequency and severity of post-ERCP pancreatitis (PEP).
  
  
  METHODS
  A prospective, double-blind, placebo-controlled trial was conducted in two tertiary referral centers, with 540 eligible patients randomized to receive either combined therapy with diclofenac 100 mg rectally 30 to 60 minutes before ERCP plus somatostatin 0.25 mg/h for 6 hours (group A), or a placebo suppository identical in appearance to the diclofenac along with saline solution (group B). Patients were clinically evaluated and serum amylase levels were determined before ERCP and at 6 and 24 hours post-procedure. Standardized criteria were used to diagnose and grade the severity of PEP. Adverse events were recorded prospectively.
  
  
  RESULTS
  There were no statistical differences between the groups regarding demographic data, ERCP findings, and procedure risk factors for PEP. The overall incidence of acute pancreatitis was 7.2 %. The PEP rate was significantly lower in the patients who received the combination therapy than in controls (4.7 % vs. 10.4 %, P = 0.015). Previous history of acute pancreatitis (P = 0.001), pancreatic opacification of first-class branches and beyond (P = 0.008), and absence of pharmacoprophylaxis (P = 0.023) were identified as independent risk factors for PEP in multivariate analysis.
  
  
  CONCLUSIONS
  Although combined prophylactic therapy with diclofenac plus somatostatin was promising in reducing frequency of PEP, further comparative large-scale studies are needed to confirm our findings before definitive conclusions can be drawn.
authors.affiliation: Department of Endoscopy and Motility Unit, G. Gennimatas General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece. gchatzimav@yahoo.gr
authors.forename: P
authors.initials: P
authors.lastname: Katsinelos
authors.forename: K
authors.initials: K
authors.lastname: Fasoulas
authors.forename: G
authors.initials: G
authors.lastname: Paroutoglou
authors.forename: G
authors.initials: G
authors.lastname: Chatzimavroudis
authors.forename: A
authors.initials: A
authors.lastname: Beltsis
authors.forename: S
authors.initials: S
authors.lastname: Terzoudis
authors.forename: T
authors.initials: T
authors.lastname: Katsinelos
authors.forename: E
authors.initials: E
authors.lastname: Dimou
authors.forename: C
authors.initials: C
authors.lastname: Zavos
authors.forename: A
authors.initials: A
authors.lastname: Kaltsa
authors.forename: J
authors.initials: J
authors.lastname: Kountouras
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000681:Amylases / Q000097:blood; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D004008:Diclofenac / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006728:Hormones / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D010195:Pancreatitis / Q000201:enzymology / Q000209:etiology / Q000517:prevention & control*; D012307:Risk Factors; D013004:Somatostatin / Q000627:therapeutic use*
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D006728:Hormones; D004008:Diclofenac; D013004:Somatostatin; D000681:Amylases