Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04633486 |
| Other study ID # |
829/2020BO2 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2012 |
| Est. completion date |
November 15, 2019 |
Study information
| Verified date |
November 2020 |
| Source |
University Hospital Tuebingen |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Intestinal transplantation is associated with high numbers of ejection events. A close
endoscopic controll of the intestinal graft is possible. Sasaki et al. presented 2002 an
endoscopic score using zoom-endoscopes for early detection of rejection events.
Description:
Small bowel transplantation is a potentially life-saving procedure for patients with
irreversible gut failure, especially for those with total parenteral nutrition complications,
inability to adapt to quality-of-life limitations posed by intestinal failure, and high risk
of death if the native gut is not removed. Endoscopy provides the quickest method for
assessing the overall health of graft mucosa and is essential in obtaining specimens from
large areas for histologic evaluation, which continues to remain the gold standard for a
diagnosis of rejection. Recently, the use of zoom videoendoscopy has been reported as a
better evaluation of intestinal mucosa than the use of a standard endoscope. Acute cellular
rejection in short-term follow-up, appears with acute and dramatic clinical symptoms (fever,
vomiting, nausea, increased stomal output/diarrhea, abdominal pain, and distension), so that
it is rarely predictable with surveillance.
Comparison of endoscopic and histo-pathologic findings should be performed.
