Recruiting

Observational Study

Sponsor:

Sahlgrenska University Hospital

Code:

NCT03444675

Conditions

Transplant; Intestine

Transplant; Complication, Rejection

Transplant; Failure, Bowel

Enteritis

Mucosal Inflammation

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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).

Conditions

Transplant; Intestine

Transplant; Complication, Rejection

Transplant; Failure, Bowel

Enteritis

Mucosal Inflammation

Study ID

NCT03444675

Start date

Apr 29, 2014

Status verified date

May, 2020

Completion date

May 1, 2023

Anticipated

Primary completion date

May 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • contraindications for ileoscopy

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Endoscopic evaluation [ Time Frame: 7 years ]

Central Contacts and Locations

Central contacts

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

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

Locations

MedStar Georgetown University Hospital

Recruiting

Washington, District of Columbia, United States, 20007

More Information

Sponsor

Sahlgrenska University Hospital

Last update posted

May 15, 2020

Last verified

May, 2020

Keywords

  • Transplantation; intestine
  • endoscopy
  • severity score
  • transplant rejection
  • transplant; complications

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sahlgrenska University Hospital on 2020-05-15.