Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT00821405 |
| Other study ID # |
200808062R |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
January 12, 2009 |
| Last updated |
January 12, 2009 |
| Start date |
March 2009 |
| Est. completion date |
March 2010 |
Study information
| Verified date |
January 2009 |
| Source |
National Taiwan University Hospital |
| Contact |
Jenq-Wen Huang, MD |
| Phone |
+886-2-23123456 |
| Email |
007378[@]ntuh.gov.tw |
| Is FDA regulated |
No |
| Health authority |
Taiwan: Department of Health |
| Study type |
Observational
|
Clinical Trial Summary
Use ultrasound and computed tomography to evaluate the condition of peritoneum(thickness,
calcified, etc. )and correlate the relationship between the peritoneum and other clinical
condition
Description:
The peritoneum after long-term peritoneal dialysis is inevitably associated with fibrosis,
which further compromises the efficiency of dialysis and ultrafiltration, or even worse the
development of encapsulating sclerosing peritonitis (EPS) and mortality. Transabdominal
ultrasonography and computed tomography has been reported in the diagnosis of EPS. Until
now, it remains a critical clinical issue to early diagnose thickening of peritoneum and
preventing the formation of EPS. Transabdominal ultrasonography and computed tomography are
convenient and non-invasive, and has been reported to detect the thickening of peritoneum in
pediatric PD patients with a history of peritonitis.
Our recent published study confirmed the utility of transabdominal ultrasonography in the
evaluation of parietal peritoneum in adult PD patients. In previous work, we examined and
compared eighteen adult PD patients with PD duration of more than 7 years with other
eighteen adult PD patients wit PD duration of less than 1 year. Our results indicated that
sonographic thickness is associated with PD peritoneal transport characteristics but not
with the duration of PD. This work was just published in Nephrology, Dialysis and
Transplantation in year 2008. We believe that was the earliest published ultrasonographic
study in adult PD patients.
This proposed study aims to extend from previous study by increasing examinee population to
include all adult PD patients as a cross sectional observational study. We will utilize
previously published sonographic examination method on PD patients (both B-mode and Doppler
ultrasonography). We will collect the blood, urine and peritoneal effluent sample at the
same time. We hope that through this large-scale survey we can elucidate more clearly the
relationship between morphology and functional/transport characteristics of the parietal
peritoneum during the natural course of renal replacement therapy with peritoneal dialysis.
The results will form our basis of future longitudinal serial follow-ups for the adult PD
patients. Besides, for those PD patients with suspected peritonitis, we will also perform
non-invasive ultrasonographic examinations and collect relevant samples on the initial days
of hospitalization in order to establish an "early predicting model" of severe,
medical-refractory peritonitis by using transabdominal ultrasonography.
Peritoneum and bowel wall calcifications are found frequently in EPS, and although while
pre-EPS stage. This study will utilize computed tomography to detect peritoneum and bowel
calcifications in PD patients. We hope to found the relationship between calcification,
peritoneum function, peritonitis frequency and future possibility of EPS.
