The Endoscopic Assesment of Intestinal Grafts

• Conditions: Transplant; Intestine; Mucosal Inflammation; Enteritis; Transplant; Complication, Rejection; Transplant; Failure, Bowel

• Registration Number: NCT03444675
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-29
• Study First Submitted: 2018-02-19
• Study First Submitted QC: 2018-02-19
• Study First Posted: 2018-02-23
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-12
• Last Update Posted: 2020-05-15
• Primary Completion: 2022-05-01
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• transplantation of a segment of small intestine (as isolated graft or together with other organs)

Exclusion Criteria

• contraindications for ileoscopy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endoscopic evaluation	7 years	To validate the GITES grading system in intestinal graft recipients using high-definition white light endoscopy

Secondary Outcome Measures

Name	Time	Method
Correlations with histology and Clinical course	1 year	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.
Performance of the grading score	1 year	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;

Trial Locations

Locations (4)

Favaloro Foundation University Hospital; 🇦🇷 Buenos Aires, Argentina

MedStar Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States

Hospital Universitario "La Paz"; 🇪🇸 Madrid, Spain

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden