An observational study in Transplant; Intestine, Transplant; Complication, Rejection and Transplant; Failure, Bowel, sponsored by Sahlgrenska University Hospital. Status unknown at 4 sites in 4 countries. Per ClinicalTrials.gov, last updated 2020-05-15.
Sponsored by Sahlgrenska University Hospital · Observational
The study validates prospectively a new endoscopic scoring system (Gothenburg Intestinal Transplant Endoscopy Score, GITES) designed to summarize and stratify the abnormal ileal endoscopic findings after intestinal transplantation. GITES is a five-tier, four grade score which asseses mucosal friability, mucosal erythema and mucosal injury (ulcerations) as well as villous changes according to severity. These features (i.e., endoscopic descriptors) are also grouped from mild to very severe in the same sequence as observed during the progression of several pathologic conditions encountered after intestinal transplantation (acute rejection, infectious enteritis).
34 studies on the registry are indexed under Enteritis; 7 are open to participants now.
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All patients (pediatric or adult) undergoing intestinal transplantation (isolated intestine, liver-intestine, multivisceral, including colon or other organs) irrespective of diagnosis; patients already transplanted can also be included.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Endoscopic evaluation
To validate the GITES grading system in intestinal graft recipients using high-definition white light endoscopy
Time frame: 7 years
Correlations with histology and Clinical course
Comparison and correlation of clinical and histopathological data with endoscopic findings to evaluate the conditions leading to the mucosal alterations defined by established endoscopic descriptors and GITES.
Time frame: 1 year
Performance of the grading score
Endpoints include sensitivity, specificity, positive predictive value, negative predictive value as well as inter- and intraobserver variation in the evaluation of the mucosal alterations by means of GITES and using high-definition white light endoscopy;
Time frame: 1 year
This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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