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

Endoscopically One-year Follow-up in Patients After Small-bowel Transplantation, Role of SASAKI Score

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.

Study Overview

• Status: Completed
• Conditions: Intestinal Graft Dysfunction
• Intervention / Treatment: Diagnostic test: zoom-endoscopy

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 Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• Germany
  • Tuebingen, Germany, 72076
    • University Hospital of Tuebingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Intestinal transplant reciepients since 2005

Description

Inclusion Criteria:

• intestinal transplant recipients

Exclusion Criteria:

• younger age (< 16)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of congruent findings of zoom-endoscopy and pathological examinations	Reliability of zoom-endoscopy and pathological examinations	12 months

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2012
• Primary Completion (Actual): November 15, 2019
• Study Completion (Actual): November 15, 2019

Study Registration Dates

• First Submitted: November 6, 2020
• First Submitted That Met QC Criteria: November 12, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Actual): November 18, 2020
• Last Update Submitted That Met QC Criteria: November 12, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: endoscopic monitoring, intestinal transplantation
• Other Study ID Numbers: 829/2020BO2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No