Peritoneum CalcificationNCT00821405
Study of Peritoneal/Bowel Morphology and Splanchnic Hemodynamics by Sonography, Doppler Ultrasound and Computed Tomography in CAPD Patients
An observational study of Peritoneum Calcification and Bowel Wall Calcification, run by National Taiwan University Hospital at 1 site in Taiwan.
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 Read more about this study
- Who is it for?
- Ages 15 to 90 years
- Conditions the study is for
- Peritoneum Calcification, Bowel Wall Calcification
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2009to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients received peritoenal dialysis more than 3 months
Who may be able to join
- peritoneal dialysis more than 3 months
Who cannot join
- 1. pregnancy 2. received CT in recent 3 months
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, 100
Jenq-Wen Huang, MD, +886-2-23123456 ext. 63288, 007378@ntuh.gov.tw
About this study
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
Read the detailed 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.
- Conditions
- Peritoneum Calcification, Bowel Wall Calcification
- Keywords
- Number : 250~300 patients, Correlation between PET, glucose loading and peritoneal thickness/calcification
- Medical subject headings
- Calcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| peritoneal dialysis | peritoneal dialysis patient lasting for more than 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
peritoneal thickness, calcification, PET, glucose loading
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2009 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneum CalcificationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821405
- Sponsor's protocol ID
- 200808062R
- Status last verified
- Jan 2009
- First submitted
- 12 Jan 2009
- Last updated
- 13 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Peritoneal/Bowel Morphology and Splanchnic Hemodynamics by Sonography, Doppler Ultrasound and Computed Tomography in CAPD Patients
- ClinicalTrials.gov ID
- NCT00821405
- Acronym / sponsor ID
- 200808062R
- Conditions
- Peritoneum Calcification, Bowel Wall Calcification
- Keywords
- Number : 250~300 patients, Correlation between PET, glucose loading and peritoneal thickness/calcification
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 13 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| peritoneal dialysis | – | –peritoneal dialysis patient lasting for more than 3 months |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients received peritoenal dialysis more than 3 months
Key inclusion criteria (1 listed)
- peritoneal dialysis more than 3 months
Key exclusion criteria (1 listed)
- 1. pregnancy 2. received CT in recent 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
peritoneal thickness, calcification, PET, glucose loading
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2009.
Related trials for Peritoneum Calcification
Active, not recruitingObservational study
Cardiovascular and Bone Mineral Markers in Dialysis Patients and Healthy Controls
End-Stage Kidney Disease (ESKD), Hemodialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneum Calcification and Bowel Wall Calcification, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jenq-Wen Huang, MD (+886-2-23123456 ext. 63288, 007378@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peritoneal thickness, calcification, PET, glucose loading (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2009.