The Endoscopic Assesment of Intestinal Grafts

NCT03444675 — Unknown, 80 participants, Sahlgrenska University Hospital

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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

Registry	NCT03444675, acronym INTEGRATE
Status	Unknown
Study type	Observational
Enrollment	80 (Estimated)
Sponsor	Sahlgrenska University Hospital (Other); collaborators: Favaloro Foundation University Hospital, Buenos Aires, Argentina, MedStar Georgetown University Hospital, Hospital Universitario La Paz
Conditions	Transplant; Intestine, Transplant; Complication, Rejection, Transplant; Failure, Bowel, Enteritis, Mucosal Inflammation
Dates	start 2014-04-29, primary completion 2022-05-01 (estimated), completion 2023-05-01 (estimated), first posted 2018-02-23, last updated 2020-05-15
Locations	4 sites in United States, Argentina, Spain, Sweden

-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).

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+Outcome measures

Primary outcomes

Endoscopic evaluation [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]: 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

Sex: All

Inclusion Criteria:

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

Exclusion Criteria:

* contraindications for ileoscopy

+Locations (4)

Facility	City	Country	Status
MedStar Georgetown University Hospital	Washington D.C., District of Columbia	United States	Recruiting
Favaloro Foundation University Hospital	Buenos Aires	Argentina	Recruiting
Hospital Universitario "La Paz"	Madrid	Spain	Recruiting
Sahlgrenska University Hospital	Gothenburg	Sweden	Recruiting

+Publications

Sigurdsson L, Reyes J, Putnam PE, del Rosario JF, Di Lorenzo C, Orenstein SR, Todo S, Kocoshis SA. Endoscopies in pediatric small intestinal transplant recipients: five years experience. Am J Gastroenterol. 1998 Feb;93(2):207-11. doi: 10.1111/j.1572-0241.1998.00207.x. PMID 9468243
Tabasco-Minguillan J, Weber K, Nelson F, Hutson W, Furukawa H, Abu-Elmagd K, Todo S, Rakela J. Variability in the interpretations of endoscopic findings in patients with intestinal transplantation. Transplant Proc. 1996 Oct;28(5):2775-6. No abstract available. PMID 8908053
Varkey J, Stotzer PO, Simren M, Herlenius G, Oltean M. The endoscopic surveillance of the transplanted small intestine: a single center experience and a proposal for a grading score. Scand J Gastroenterol. 2018 Feb;53(2):134-139. doi: 10.1080/00365521.2017.1411523. Epub 2017 Dec 12. PMID 29233031

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