A Multi-centre, Longitudinal (Cohort) Study in Patients Undergoing Intestinal or Multivisceral Transplantation to Validate Gothenburg Intestinal Transplant Endoscopy Score (GITES) and Evaluate Its Clinical Performance
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Transplant; Intestine
- Sponsor
- Sahlgrenska University Hospital, Sweden
- Enrollment
- 80
- Locations
- 4
- Primary Endpoint
- Endoscopic evaluation
- Last Updated
- 5 years ago
Overview
Brief Summary
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).
Investigators
Mihai Oltean
Dr.
Sahlgrenska University Hospital, Sweden
Eligibility Criteria
Inclusion Criteria
- •transplantation of a segment of small intestine (as isolated graft or together with other organs)
Exclusion Criteria
- •contraindications for ileoscopy
Outcomes
Primary Outcomes
Endoscopic evaluation
Time Frame: 7 years
To validate the GITES grading system in intestinal graft recipients using high-definition white light endoscopy
Secondary Outcomes
- Correlations with histology and Clinical course(1 year)
- Performance of the grading score(1 year)