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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03444675

Acronym

INTEGRATE

Enrollment

Registered

2018-02-23

Start date

2014-04-29

Completion date

2023-05-01

Last updated

2020-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enteritis, Mucosal Inflammation, Transplant; Complication, Rejection, Transplant; Failure, Bowel, Transplant; Intestine

Keywords

Transplantation; intestine, endoscopy, severity score, transplant rejection, transplant; complications

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* contraindications for ileoscopy

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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;

Countries

Argentina, Spain, Sweden, United States

Contacts

Primary ContactMihai Oltean, M.D., Ph.D.

mihai.oltean@surgery.gu.se00 46 31 342 1000

Outcome results