The Endoscopic Assesment of Intestinal Grafts

Transplant; Complication, Rejection Clinical Trial

— INTEGRATE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03444675
• Other study ID #: GBG18001
• Status: Recruiting
• Start date: April 29, 2014
• Est. completion date: May 1, 2023

Study information

• Verified date: May 2020
• Source: Sahlgrenska University Hospital, Sweden
• Contact: Mihai Oltean, M.D., Ph.D.
• Phone: 00 46 31 342 1000
• Email: mihai.oltean[@]surgery.gu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• contraindications for ileoscopy

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Argentina	Favaloro Foundation University Hospital	Buenos Aires
Spain	Hospital Universitario "La Paz"	Madrid
Sweden	Sahlgrenska University Hospital	Gothenburg
United States	MedStar Georgetown University Hospital	Washington	District of Columbia

Sponsors (5)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden	Favaloro Foundation University Hospital, Buenos Aires, Argentina, Hospital Universitario La Paz, MedStar Georgetown University Hospital, Washington DC, Sahlgrenska University Hospital, Gothenburg, Sweden

Countries where clinical trial is conducted

United States,  Argentina,  Spain,  Sweden, 

References & Publications (3)

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. — View Citation

Tabasco-Minguillán 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. — View Citation

Varkey J, Stotzer PO, Simrén 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endoscopic evaluation	To validate the GITES grading system in intestinal graft recipients using high-definition white light endoscopy	7 years
Secondary	Correlations with histology and Clinical course	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.	1 year
Secondary	Performance of the grading score	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;	1 year