Prospective trial comparing solid-state catheter and water-perfusion triple-lumen catheter for sphincter of Oddi manometry done at the time of ERCP

Abstract

Background: Sphincter of Oddi manometry is the reference standard for the diagnosis of sphincter of Oddi dysfunction. Numerous studies have established ranges of normal values as well as typical readings in pathologic conditions. All these studies have been done using a water-perfused, triple-lumen catheter (TLC). A recently approved, new generation, solid-state catheter (SSC) has potential advantages, but concerns have been raised as to whether the pressures obtained by TLCs are reproducible by SSCs. To date, no data exist on the accuracy of sphincter of Oddi pressure measurements with the new-generation SSCs.

Objective: To evaluate the accuracy of the SSC by using the TLC as the reference standard.

Design: Prospective crossover trial.

Setting: A tertiary academic center.

Patients: Thirty patients with clinical indications for sphincter of Oddi manometry.

Interventions: Sphincter of Oddi manometry with TLC and SSC in the same patient.

Main outcome measurements: Accuracy of sphincter of Oddi pressure measurements.

Results: 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.

Limitations: Lack of blinding.

Conclusions: Measurement of sphincter of Oddi pressures with the SSC is accurate, and results were essentially identical to those of the water-perfused catheter system.