To evaluate the accuracy of the SSC by using the TLC as the reference standard.
Prospective crossover trial.
A tertiary academic center.
Thirty patients with clinical indications for sphincter of Oddi manometry.
Sphincter of Oddi manometry with TLC and SSC in the same patient.
Accuracy of sphincter of Oddi pressure measurements.
A total of 376 pressure measurements in 47 sphincter segments (24 biliary, 23 pancreatic) were obtained. Manometry results were abnormal in 10 of 24 biliary sphincters and 12 of 23 pancreatic sphincters. There was complete agreement on the final results of the sphincter of Oddi manometry (normal/abnormal) between the TLC and SSC (accuracy 100 % ). A split-plot analysis of the 378 individual measurements was performed. The P value of .9966 was insignificant, consistent with no catheter effect on the measurements.
Lack of blinding.
Measurement of sphincter of Oddi pressures with the SSC is accurate, and results were essentially identical to those of the water-perfused catheter system.