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The Endoscopic Assesment of Intestinal Grafts (INTEGRATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03444675
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : May 15, 2020
Sponsor:
Collaborators:
Sahlgrenska University Hospital, Gothenburg, Sweden
Favaloro Foundation University Hospital, Buenos Aires, Argentina
MedStar Georgetown University Hospital, Washington DC
Hospital Universitario La Paz
Information provided by (Responsible Party):
Mihai Oltean, Sahlgrenska University Hospital, Sweden

Study Description
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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).

Condition or disease
Transplant; Intestine Transplant; Complication, Rejection Transplant; Failure, Bowel Enteritis Mucosal Inflammation

Study Design
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 29, 2014
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : May 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Endoscopic evaluation [ Time Frame: 7 years ]
    To validate the GITES grading system in intestinal graft recipients using high-definition white light endoscopy


Secondary Outcome Measures :
  1. Correlations with histology and Clinical course [ Time Frame: 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.

  2. Performance of the grading score [ Time Frame: 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 Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • contraindications for ileoscopy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444675


Contacts
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Contact: Mihai Oltean, M.D., Ph.D. 00 46 31 342 1000 mihai.oltean@surgery.gu.se

Locations
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United States, District of Columbia
MedStar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Stuart Kaufman, MD         
Argentina
Favaloro Foundation University Hospital Recruiting
Buenos Aires, Argentina, C1093AAS
Contact: Carolina Rumbo, MD         
Spain
Hospital Universitario "La Paz" Recruiting
Madrid, Spain
Contact: Esther Ramos Boluda, MD, PhD         
Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, 41345
Contact: Mihai Oltean, M.D., Ph.D.         
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Sahlgrenska University Hospital, Gothenburg, Sweden
Favaloro Foundation University Hospital, Buenos Aires, Argentina
MedStar Georgetown University Hospital, Washington DC
Hospital Universitario La Paz
More Information
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Publications:

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Responsible Party: Mihai Oltean, Dr., Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT03444675    
Other Study ID Numbers: GBG18001
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mihai Oltean, Sahlgrenska University Hospital, Sweden:
Transplantation; intestine
endoscopy
severity score
transplant rejection
transplant; complications
Additional relevant MeSH terms:
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Enteritis
Mucositis
Inflammation
Pathologic Processes
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Mouth Diseases
Stomatognathic Diseases