IOPENTOL (IMAGOPAQUE(R)-250) COMPARED WITH DIATRIZOATE (UROGRAFIN(R)-219) IN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) - A CLINICAL-TRIAL ASSESSING SAFETY (ADVERSE EVENTS AND S-PANCREATIC ISOAMYLASE) AND DIAGNOSTIC INFORMATION (VAS)

The efficacy and safety of the non-ionic contrast medium iopentol, 250 mg I/ml (Imagopaque(R), Nycomed Imaging AS, Oslo, Norway) were evalua ted and compared to those of the ionic contrast medium diatrizoate 219 mg I/ml (Urografin(R), Schering AG, Berlin, Germany). The trial was c arried out as a randomized, double-blind comparative two-group study. One hundred and sixteen patients completed the study: 59 received iope ntol and 57 received diatrizoate, the contrast medium used according t o routine hospital procedure for ERCP. Demographic data and details of the ERCP procedure were comparable for the two contrast medium groups . Safety was assessed by monitoring serum pancreatic iso-amylase and b y recording adverse events. Efficacy was evaluated through assessment of the diagnostic information and the quality of radiographs. Twenty-o ne of the patients receiving iopentol and 27 of the patients receiving diatrizoate reported adverse events during the ERCP procedure. Pain w as the kind of procedure-related event most frequently reported. Three patients experienced serious adverse events with a fatal outcome 2, 1 0 and 12 days after the ERCP procedure, respectively. The principal in vestigator concluded for all three serious adverse events that any cau sal relationship with the contrast medium injected was unlikely. A mea n change in serum pancreatic iso-amylase after contrast medium injecti on was noted in both contrast medium groups. However, statistical anal ysis did not show any significant difference between mean changes for the two groups. The efficacy results, both in terms of diagnostic info rmation and quality of radiographic visualisation, were comparable for the two contrast media. In conclusion, the study did not show any sta tistically significant differences between the two contrast media as r egards safety or efficacy in ERCP.