NCT03444675

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).

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2014

Longer than P75 for all trials

Geographic Reach
4 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 29, 2014

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

Enrollment Period

8 years

First QC Date

February 19, 2018

Last Update Submit

May 12, 2020

Conditions

Transplant; IntestineTransplant; Complication, RejectionTransplant; Failure, BowelEnteritisMucosal Inflammation

Keywords

Transplantation; intestineendoscopyseverity scoretransplant rejectiontransplant; complications

Outcome Measures

Primary Outcomes (1)

  • Endoscopic evaluation

    To validate the GITES grading system in intestinal graft recipients using high-definition white light endoscopy

    7 years

Secondary Outcomes (2)

  • Correlations with histology and Clinical course

    1 year

  • Performance of the grading score

    1 year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • contraindications for ileoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

RECRUITING

Favaloro Foundation University Hospital

Buenos Aires, C1093AAS, Argentina

RECRUITING

Hospital Universitario "La Paz"

Madrid, Spain

RECRUITING

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

RECRUITING

Related 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. doi: 10.1111/j.1572-0241.1998.00207.x.

    PMID: 9468243BACKGROUND

  • 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: 8908053BACKGROUND

  • 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: 29233031BACKGROUND

MeSH Terms

Conditions

Rejection, PsychologyEnteritisMucositis

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

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

CONTACT

00 46 31 342 1000mihai.oltean@surgery.gu.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

February 19, 2018

First Posted

February 23, 2018

Study Start

April 29, 2014

Primary Completion

May 1, 2022

Study Completion

May 1, 2023

Last Updated

May 15, 2020

Record last verified: 2020-05

Locations

AR(1)ES(1)US(1)SE(1)