Clinical trial NCT03444675: The Endoscopic Assesment of Intestinal Grafts
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Transplant; Intestine
Transplant; Complication, Rejection
Transplant; Failure, Bowel
Enteritis
Mucosal Inflammation
Keywords: Transplantation; intestine
endoscopy
severity score
transplant rejection
transplant; complications
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Favaloro Foundation University Hospital, Buenos Aires, Argentina
name: MedStar Georgetown University Hospital, Washington DC
name: Hospital Universitario La Paz
First posted: 2018-02-23
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients (pediatric or adult) undergoing intestinal transplantation (isolated intestine, liver-intestine, multivisceral, including colon or other organs) irrespective of diagnosis; patients already transplanted can also be included.

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).


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* contraindications for ileoscopy

Primary outcomes:
measure: Endoscopic evaluation
timeFrame: 7 years
Secondary outcomes:
measure: Correlations with histology and Clinical course
timeFrame: 1 year
measure: Performance of the grading score
timeFrame: 1 year
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Buenos Aires
country: Argentina
facility: Favaloro Foundation University Hospital
city: Madrid
country: Spain
facility: Hospital Universitario "La Paz"
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.