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

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ClinicalTrials.gov Identifier: NCT04633486
Recruitment Status : Completed
First Posted : November 18, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Study Description
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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.

Condition or disease Intervention/treatment
Intestinal Graft Dysfunction 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 Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 12 Months
Official Title: Endoscopically One-year Follow-up in Patients After Small-bowel Transplantation, Role of SASAKI Score
Actual Study Start Date : April 1, 2012
Actual Primary Completion Date : November 15, 2019
Actual Study Completion Date : November 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: zoom-endoscopy
    Endoscopic monitoring of intestinal transplant recipients is done with zoom-endoscopes for exact diagnostic of intestinal mucosa.
    Other Name: ZVE

Outcome Measures
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Primary Outcome Measures :
  1. Rate of congruent findings of zoom-endoscopy and pathological examinations [ Time Frame: 12 months ]
    Reliability of zoom-endoscopy and pathological examinations


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Intestinal transplant reciepients since 2005
Criteria

Inclusion Criteria:

  • intestinal transplant recipients

Exclusion Criteria:

  • younger age (< 16)
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): NCT04633486


Locations
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Germany
University Hospital of Tuebingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
More Information
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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT04633486    
Other Study ID Numbers: 829/2020BO2
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 University Hospital Tuebingen:
endoscopic monitoring, intestinal transplantation