Trials / Unknown
UnknownNCT03444675
The Endoscopic Assesment of Intestinal Grafts
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
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 80 (estimated)
- Sponsor
- Sahlgrenska University Hospital · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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).
Conditions
- Transplant; Intestine
- Transplant; Complication, Rejection
- Transplant; Failure, Bowel
- Enteritis
- Mucosal Inflammation
Timeline
- Start date
- 2014-04-29
- Primary completion
- 2022-05-01
- Completion
- 2023-05-01
- First posted
- 2018-02-23
- Last updated
- 2020-05-15
Locations
4 sites across 4 countries: United States, Argentina, Spain, Sweden
Source: ClinicalTrials.gov record NCT03444675. Inclusion in this directory is not an endorsement.