Endoscopically One-year Follow-up in Patients After Small-bowel Transplantation

Completed

• Conditions: Intestinal Graft Dysfunction

• Registration Number: NCT04633486
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

Intestinal transplantation is associated with high numbers of ejection events. A close endoscopic controll of the intestinal graft is possible. Sasaki et al. presented 2002 an endoscopic score using zoom-endoscopes for early detection of rejection events.

Detailed Description

Small bowel transplantation is a potentially life-saving procedure for patients with irreversible gut failure, especially for those with total parenteral nutrition complications, inability to adapt to quality-of-life limitations posed by intestinal failure, and high risk of death if the native gut is not removed. Endoscopy provides the quickest method for assessing the overall health of graft mucosa and is essential in obtaining specimens from large areas for histologic evaluation, which continues to remain the gold standard for a diagnosis of rejection. Recently, the use of zoom videoendoscopy has been reported as a better evaluation of intestinal mucosa than the use of a standard endoscope. Acute cellular rejection in short-term follow-up, appears with acute and dramatic clinical symptoms (fever, vomiting, nausea, increased stomal output/diarrhea, abdominal pain, and distension), so that it is rarely predictable with surveillance.

Comparison of endoscopic and histo-pathologic findings should be performed.

Study Timeline

• Study Start: 2012-04-01
• Primary Completion: 2019-11-15
• Study Completion: 2019-11-15
• Status Verified: 2020-11
• Study First Submitted: 2020-11-06
• Study First Submitted QC: 2020-11-12
• Last Update Submitted: 2020-11-12
• Study First Posted: 2020-11-18
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• intestinal transplant recipients

Exclusion Criteria

• younger age (< 16)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of congruent findings of zoom-endoscopy and pathological examinations	12 months	Reliability of zoom-endoscopy and pathological examinations

Trial Locations

Locations (1)

University Hospital of Tuebingen; 🇩🇪 Tuebingen, Germany