The Endoscopic Assesment of Intestinal Grafts

NCT ID: NCT03444675

Last Updated: 2020-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-29

Study Completion Date

2023-05-01

Brief Summary

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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).

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* contraindications for ileoscopy
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Favaloro Foundation University Hospital, Buenos Aires, Argentina

UNKNOWN

Sponsor Role collaborator

MedStar Georgetown University Hospital, Washington DC

UNKNOWN

Sponsor Role collaborator

Hospital Universitario La Paz

OTHER

Sponsor Role collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mihai Oltean

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Favaloro Foundation University Hospital

Buenos Aires, , Argentina

Site Status RECRUITING

Hospital Universitario "La Paz"

Madrid, , Spain

Site Status RECRUITING

Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status RECRUITING

Countries

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United States Argentina Spain Sweden

Central Contacts

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Mihai Oltean, M.D., Ph.D.

Role: CONTACT

00 46 31 342 1000

Facility Contacts

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Stuart Kaufman, MD

Role: primary

Carolina Rumbo, MD

Role: primary

Esther Ramos Boluda, MD, PhD

Role: primary

Mihai Oltean, M.D., Ph.D.

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 9468243 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8908053 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29233031 (View on PubMed)

Other Identifiers

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GBG18001

Identifier Type: -

Identifier Source: org_study_id

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