Transplant; IntestineINTEGRATENCT03444675
The Endoscopic Assesment of Intestinal Grafts
An observational study of Transplant; Intestine and Transplant; Complication, Rejection, run by Sahlgrenska University Hospital at 4 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transplant; Intestine, Transplant; Complication, Rejection, Transplant; Failure, Bowel
- How many people
- 80 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 29 Apr 2014to 1 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- transplantation of a segment of small intestine (as isolated graft or together with other organs)
Who cannot join
- contraindications for ileoscopy
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
United States1 site, 1 recruiting
- Recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Stuart Kaufman, MD
Argentina1 site, 1 recruiting
- Recruiting
Favaloro Foundation University Hospital
Buenos Aires, C1093AAS
Carolina Rumbo, MD
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario "La Paz"
Madrid
Esther Ramos Boluda, MD, PhD
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, 41345
Mihai Oltean, M.D., Ph.D.
About this study
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
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).
- Conditions
- Transplant; Intestine, Transplant; Complication, Rejection, Transplant; Failure, Bowel, Enteritis, Mucosal Inflammation
- Keywords
- Transplantation; intestine, endoscopy, severity score, transplant rejection, transplant; complications
- Medical subject headings
- Rejection, Psychology, Enteritis, Mucositis
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic evaluation
To validate the GITES grading system in intestinal graft recipients using high-definition white light endoscopy
Measured: 7 years
Secondary outcomes (2)
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.
Measured: 1 year
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;
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start29 Apr 2014
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Transplant; IntestineStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Favaloro Foundation University Hospital, Buenos Aires, Argentina, MedStar Georgetown University Hospital, Hospital Universitario La Paz
- Responsible party
- Principal investigator, Mihai Oltean, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444675
- Sponsor's protocol ID
- GBG18001
- Acronym
- INTEGRATE
- Status last verified
- May 2020
- First submitted
- 19 Feb 2018
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 9468243Tabasco-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.
PubMed 8908053Varkey 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.
PubMed 29233031
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03444675
- Acronym / sponsor ID
- INTEGRATE / GBG18001
- Conditions
- Transplant; Intestine, Transplant; Complication, Rejection, Transplant; Failure, Bowel, Enteritis, Mucosal Inflammation
- Keywords
- Transplantation; intestine, endoscopy, severity score, transplant rejection, transplant; complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Favaloro Foundation University Hospital, Buenos Aires, Argentina, MedStar Georgetown University Hospital, Hospital Universitario La Paz
- Study start
- 29 Apr 2014 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- transplantation of a segment of small intestine (as isolated graft or together with other organs)
Key exclusion criteria (1 listed)
- contraindications for ileoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Endoscopic evaluation
Time frame: 7 years
To validate the GITES grading system in intestinal graft recipients using high-definition white light endoscopy
2 secondary outcomes
Correlations with histology and Clinical course
Time frame: 1 year
Performance of the grading score
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
- Background: PubMed 9468243Sigurdsson 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.
- Background: PubMed 8908053Tabasco-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.
- Background: PubMed 29233031Varkey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplant; Intestine and Transplant; Complication, Rejection, run by Sahlgrenska University Hospital at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Argentina, Spain, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mihai Oltean, M.D., Ph.D. (00 46 31 342 1000, mihai.oltean@surgery.gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoscopic evaluation (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03444675, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2020.