University Hospital of Tuebingen
Tübingen, 72076, Germany
Completed
NCT Number: NCT04633486
Endoscopically One-year Follow-up in Patients After Small-bowel Transplantation
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.
Completed
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Conditions
Age range
16 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- intestinal transplant recipients
Exclusion criteria
- younger age (< 16)
Treatment and study plan
zoom-endoscopy
Diagnostic TestEndoscopic monitoring of intestinal transplant recipients is done with zoom-endoscopes for exact diagnostic of intestinal mucosa.
Other names: ZVE
Primary outcomes
-
Rate of congruent findings of zoom-endoscopy and pathological examinations
Time frame: 12 months
Reliability of zoom-endoscopy and pathological examinations
Sponsors and collaborators
Lead sponsor
University Hospital Tuebingen
Other
Registry information
Official study title
Endoscopically One-year Follow-up in Patients After Small-bowel Transplantation, Role of SASAKI Score
Important dates
- Study start
- 2012
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Nov 18, 2020
- Registry last updated
- Nov 18, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.