| Purpose and SignificanceSO plays an important role in the regulation of secretion and excretion of bile and pancreatic juice under both physiological and pathological conditions. Recent years, it was witnessed that the increasing awareness of the significance of reserving integrity of bile duct to its normal function, which has been a general principle for various biliary operations. For lack of direct quantitative diagnostic methods to evaluate the function of SO and unavailable objective standards judging whether to remove or to keep SO, more importance has been attached to anatomy, pathological characteristics of SO, and the development of appropriate means for the diagnosis and treatment of SO dysfunction. Little was known about the physiology, regulation mechanism and pathology of SO, neurobiological enervation and etiological mechanism of SOD. Neither do we know much about the electrophysiology of SO and relation with electrical coupled movement of biliary duct. So far oversea labs have been performing in vitro experiments on SO of animals in order to obtain data on the electrophysiological property of SO. Most researchers resorted to dynamic methods and recorded the changes of SO and bile duct pressure as a way to reflect their functions. However, as is known, measurement of biliary kinetics only serves as an indirect assessment of the function of SO with many confounding factors. On the contrary, introduction of direct collection of myoelectrical signals from SO as a direct indicator of the changes in SO function under both physiological and pathological conditions can effectively minimize the errors which unavoidably occur during measuring the pressure. Combined application of electrophysiological meansmethods and dynamic methods can serve as a better way to monitor the status of SO and offer important information about the relationship between the two different physical properties as well as to provide useful messages on the characteristic of SO under various pathological status.Based on the above analysis, this study deals with the temporal correlation between electrophysiology and dynamics of SO, focusing on the development of an applicable same-phase monitoring catheter (SPM catheter) tailored for the simultaneous measurement of both electrophysiological and dynamical property of SO. We firstly managed to establish stable platform for electrophysiological measurement and dynamical measurement of SO, upon which we monitored and compared the changes with the two items in humans SO under physiological conditions, active state and inhibitory state, which provides experimental evidence for basic studies on the SO physiology as well as for clinical studies on SO in various morbid conditions. On account of above opinions the purpose of this study is to establish a new method for SO myoelectrical recording, and to perform control research between SOD and normal individuals, so to provide experimental clues for basic research of SO and SO-related disorders.Materials and Methods1. With the application of self-made mucous membrane contact electrode, improving detection electrodes, synchronous detection by SO pressure measurement and control with traditional needle electrodes, CEM was reliable to measure SO myoelectricity. New SO myoelectrical system was performed to study large-scale experimental animals, which can verify the feasibility and reliability of new method.2. After the confirmation of Ethics Committee we studied in vivo SO myoelectricity of volunteers, so to establish and refine human body SO myoelectrical system. We performed synchronous measurement with CEM and traditional needle electrodes, SO and duodenum myoelectricity, electrophysiology and kinetics to verify the reliability of SO myoelectricity.3. With the application of suitable human body SO myoelectrical system we performed synchronous measurement of SO electrophysiology and kinetics to study the amplitude, frequency, duration of SO myoelectricity and SO pressure frequency, amplitude, frequency and basic pressure. To study the properties of SO myoelectricity and kinetics in normal human beings, and to collect the basic data of SO myoelectricity and SO measurement pressure in normal human beings.4. According to RomeIII diagnostic criteria made by International Functional Gastrointestinal Disorders Committee 2005 we collected 346 clinical SOD-suspectable cases and performed SO myoelectricity and SO pressure measurement in SOD patients under empty stomach status, Nardi test drugs motivation, cholinergic nerve inhibition by endoscope. We studied the properties of SO myoelectricity and kinetics in SOD patients, and calculated the sensitivity, specificity, accuracy, positive and negative predictive values of SO myoelectricity in normal human being.Results and Conclusions1. We successfully recorded SO myoelectrical activities of rabbits with self-made mucous membrane contact electrodes, and continuously consummate and improve rabbit SO myoelectrical animal model and experimental methods. The study verified that SO myoelectricity system with CEM has more advantage in non-invasive, high reliability and accuracy comparing with traditional needle electrodes. Based on this we adopted new SO myoelectrical system to finish large-scale experimental animals SO myocelectrical recordings and acquired satisfactory results, which further verified the feasibility and reliability of this new method.2. The clear SO myoelectrical waveforms were recorded in volunteers with self-made and suitable for human being SO myoelectrical and kinetic system, and consummated and established reliable SO myoelectrical system. The synchronous measurement with CEM and traditional needle electrodes, SO and duodenum myoelectricity, electrophysiology and kinetics to verify the reliability of SO myoelectricity all verified the reliability of SO myoelectrical detection system.3. We acquired satisfactory data and primarily established normal reference values of SO myoelectricity by synchronous measurement with SO myoelectricity and kinetics in normal human beings. Under empty stomach status human SO myoelectricity frequency is 6.5±1.3 times/minute, amplitude 137.1±14.0μV, duration 3.1±0.5 sec. We suggested the abnormal function of SO: frequency is > 10 times/minute, amplitude > 180μV, duration > 4.6 Sec .The differences of SO myoelectricity frequency, amplitude and duration between SOD patients and normal human beings are significant, whether under empty stomach status, Nardi test drugs motivation, or cholinergic nerve inhibition status. The sensitivity of SOD by SO myoelectricity is 52%, specificity 72%, accuracy 60%, positive predictive values 73% and negative predictive values 52%. The statistical results indicated that except in biliary tract type SOD1 the sensitivity and accuracy of SO myoelectricity was significantly higher than SO pressure measurement for all other SOD subtypes. It also suggested the combined application of SO pressure measurement and SO myoelectricity would provide more accurate diagnosis for SOD..
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