Iopentol (Imagopaque 250) compared with diatrizoate (Urografin 219) in endoscopic retrograde cholangio-pancreatography (ERCP). A clinical trial assessing safety (adverse events and S-pancreatic iso-amylase) and diagnostic information (VAS).

The efficacy and safety of the non-ionic contrast medium iopentol, 250 mg I/ml (Imagopaque, Nycomed Imaging AS, Oslo, Norway) were evaluated and compared to those of the ionic contrast medium diatrizoate 219 mg I/ml (Urografin, Schering AG, Berlin, Germany). The trial was carried out as a randomized, double-blind comparative two-group study. One hundred and sixteen patients completed the study: 59 received iopentol and 57 received diatrizoate, the contrast medium used according to 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 by recording adverse events. Efficacy was evaluated through assessment of the diagnostic information and the quality of radiographs. Twenty-one of the patients receiving iopentol and 27 of the patients receiving diatrizoate reported adverse events during the ERCP procedure. Pain was the kind of procedure-related event most frequently reported. Three patients experienced serious adverse events with a fatal outcome 2, 10 and 12 days after the ERCP procedure, respectively. The principal investigator concluded for all three serious adverse events that any causal relationship with the contrast medium injected was unlikely. A mean change in serum pancreatic iso-amylase after contrast medium injection was noted in both contrast medium groups. However, statistical analysis did not show any significant difference between mean changes for the two groups. The efficacy results, both in terms of diagnostic information and quality of radiographic visualisation, were comparable for the two contrast media. In conclusion, the study did not show any statistically significant differences between the two contrast media as regards safety or efficacy in ERCP.

RCT Entities:   Population Interventions Outcomes