Ultrasonic System for Diagnosis of Functional Gastrointestinal Disorders: Development, Verification and Clinical Trials

Functional gastrointestinal disorders affect millions of people spread all age regardless of race and sex. There are, however, rare diagnostic methods for the functional gastrointestinal disorders because functional disorders show no evidence of organic and physical causes. Our research group identified recently that the gastrointestinal tract well in the patients with the functional gastrointestinal disorders becomes more rigid than healthy people when palpating the abdominal regions overlaying the gastrointestinal tract. Aim of this study is, therefore, to develop a diagnostic system for the functional gastrointestinal disorders based on ultrasound technique, which can quantify the characteristic above related to the rigidity of the gastrointestinal tract well. Ultrasound system was designed. The system consisted of transmitter, ultrasonic transducer, receiver, TGC, and CPLD, and verified via a phantom test. For the phantom test, ten soft-tissue specimens were harvested from porcine. Five of them were then treated chemically to mimic a rigid condition of gastrointestinal tract well, which was induced by functional gastrointestinal disorders. Additionally, the specimens were tested mechanically to identify if the mimic was reasonable. The customized ultrasound system was finally verified through application to human subjects with/without functional gastrointestinal disorders (Normal and Patient Groups). It was identified from the mechanical test that the chemically treated specimens were more rigid than normal specimen. This finding was favorably compared with the result obtained from the phantom test. The phantom test also showed that ultrasound system well described the specimen geometric characteristics and detected an alteration in the specimens. The maximum amplitude of the ultrasonic reflective signal in the rigid specimens (0.2±0.1Vp-p) at the interface between the fat and muscle layers was explicitly higher than that in the normal specimens (0.1±0.0Vp-p). Clinical tests using our customized ultrasound system for human subject showed that the maximum amplitudes of the ultrasonic reflective signals near to the gastrointestinal tract well for the patient group (2.6±0.3Vp-p) were generally higher than those in normal group (0.1±0.2Vp-p). Here, maximum reflective signals was appeared at 20mm depth approximately from abdominal skin for all human subjects, corresponding to the location of the boundary layer close to gastrointestinal tract well. These results suggest that newly designed diagnostic system based on ultrasound technique may diagnose enough the functional gastrointestinal disorders.

Suggestion of Ultrasonic System for Diagnosis of Functional Gastrointestinal Disorders: Finite Difference Analysis, Development and Clinical Trials

The disaster from functional gastrointestinal disorders has detrimental impact on the quality of life of the effected population and imposes a tremendous social and economic burden. There are, however, rare diagnostic methods for the functional gastrointestinal disorders. Our research group identified recently that the gastrointestinal tract well in the patients with the functional gastrointestinal disorders becomes more rigid than healthy people when palpating the abdominal regions overlaying the gastrointestinal tract. Objective of current study is, therefore, identify feasibility of a diagnostic system for the functional gastrointestinal disorders based on ultrasound technique, which can quantify the characteristics above. Two-dimensional finite difference (FD) models (one normal and two rigid model) were developed to analyze the reflective characteristic (displacement) on each soft-tissue layer responded after application of ultrasound signals. The FD analysis was then based on elastic ultrasound theory. Validation of the model was performed via comparison of the characteristic of the ultrasonic responses predicted by FD analysis with that determined from the actual specimens for the normal and rigid conditions. Based on the results from FD analysis, ultrasound system for diagnosis of the functional gastrointestinal disorders was developed and clinically tested via application of it to 40 human subjects with/without functional gastrointestinal disorders who were assigned to Normal and Patient Groups. The FD models were favorably validated. The results from FD analysis showed that the maximum displacement amplitude in the rigid models (0.12 and 0.16) at the interface between the fat and muscle layers was explicitly less than that in the normal model (0.29). The results from actual specimens showed that the maximum amplitude of the ultrasonic reflective signal in the rigid models (0.2±0.1Vp-p) at the interface between the fat and muscle layers was explicitly higher than that in the normal model (0.1±0.2 Vp-p). Clinical tests using our customized ultrasound system showed that the maximum amplitudes of the ultrasonic reflective signals near to the gastrointestinal tract well for the patient group (2.6±0.3 Vp-p) were generally higher than those in normal group (0.1±0.2 Vp-p). Here, maximum reflective signals was appeared at 20mm depth approximately from abdominal skin for all human subjects, corresponding to the location of the boundary layer close to gastrointestinal tract well. These findings suggest that our customized ultrasound system using the ultrasonic reflective signal may be helpful to the diagnosis of the functional gastrointestinal disorders.

Relationship between Functional Gastrointestinal Disorders and Risk Factors: A Biomechanical Analysis

Functional gastrointestinal disorders (FGID) affect millions of people spread all age regardless of race and sex. Emotional stress and obesity have been associated with increased reporting of gastrointestinal (GI) symptoms, but the relationship between FGID and risk factors (emotional stress or obesity) is unclear. Our aim was to assess the changes of the mechanical characteristics on the gastrointestinal tracts of the mentally fatigued obese and normal rat models. Finally, using the physical characteristics with micro-indentation test, we made a close investigation into the relation between FGID and risk factors quantitatively.