INTEGRATE: The Endoscopic Assesment of Intestinal Grafts

Sponsor

Sahlgrenska University Hospital, Sweden (Other)

Overall Status

Recruiting

CT.gov ID

NCT03444675

Collaborator

Sahlgrenska University Hospital, Gothenburg, Sweden (Other), Favaloro Foundation University Hospital, Buenos Aires, Argentina (Other), MedStar Georgetown University Hospital, Washington DC (Other), Hospital Universitario La Paz (Other)

Enrollment

Locations

108.1

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Transplant; Intestine Transplant; Complication, Rejection Transplant; Failure, Bowel Enteritis Mucosal Inflammation

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 29, 2014

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

May 1, 2023

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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;

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

contraindications for ileoscopy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MedStar Georgetown University Hospital	Washington	District of Columbia	United States	20007
2	Favaloro Foundation University Hospital	Buenos Aires		Argentina	C1093AAS
3	Hospital Universitario "La Paz"	Madrid		Spain
4	Sahlgrenska University Hospital	Gothenburg		Sweden	41345