Simultaneous electrophysiological and manometric evaluation of the sphincter of Oddi

This study aims to investigate a device for the simultaneous assessment of the electrophysiological and manometric of the sphincter of Oddi (SO), as well as its potential clinical applications.

Building on our previously developed rabbit mucosal of contact electrode (CEM), we designed a triple-lumen central venous catheter-based device for simultaneous recording of electrophysiological and manometric signals of the SO in rabbits. The device was subsequently adapted to canine models with SO dimensions comparable to humans to validate the feasibility of concurrent electrophysiological and manometric recordings and to examine the correlation between these parameters. We then applied the device to healthy volunteers and patients with sphincter of Oddi dysfunction (SOD) to assess the feasibility and parameter correlation of simultaneous SO recordings under fasted state, during Nardi test stimulation, and under cholinergic inhibition. Finally, in SOD patients undergoing endoscopic papillary balloon dilation (EPBD), we evaluated the device's ability to capture post-procedural changes in SO electrophysiology and manometry device fasted state.

The simultaneous recording device was feasible and effective in rabbits, canines, and humans. In healthy volunteers, SO electrophysiological and manometric signals demonstrated characteristic patterns under the fasted state, significant enhancement following Nardi test stimulation, and notable suppression after cholinergic blockade. In SOD patients, both electrophysiological and manometric signals were markedly elevated. Finally, we demonstrated that after EPBD in SOD patients, the device remained capable of recording SO electrophysiological and manometric patterns, with both signals showing significant reductions. This provides a novel technical approach for the diagnosis and treatment of SOD.

(1) We successfully developed the first device capable of simultaneous electrophysiological and manometric detecting of the SO, with validation in both rabbit and canine models, confirming the correlation and technical feasibility of dual-parameter recording. (2) A human-compatible device was established for the first time, and its feasibility was confirmed; in healthy subjects, SO electrophysiological and manometric signals were linearly correlated in the fasted state. (3) Nardi test stimulation significantly increased both signal types, whereas cholinergic blockade effectively suppressed SO activity. (4) In SOD patients, both electrophysiological and manometric signals were markedly elevated. Finally, we demonstrated that after EPBD in SOD patients, the device remained capable of recording SO electrophysiological and manometric patterns, with both signals showing significant reductions. This provides a novel technical approach for the diagnosis and treatment of SOD.