Viewing Study NCT04633486



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Last Modification Date: 2024-10-26 @ 1:49 PM
Study NCT ID: NCT04633486
Status: COMPLETED
Last Update Posted: 2020-11-18
First Post: 2020-11-06

Brief Title: Endoscopically One-year Follow-up in Patients After Small-bowel Transplantation
Sponsor: University Hospital Tuebingen
Organization: University Hospital Tuebingen

Study Overview

Official Title: Endoscopically One-year Follow-up in Patients After Small-bowel Transplantation Role of SASAKI Score
Status: COMPLETED
Status Verified Date: 2020-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 outputdiarrhea abdominal pain and distension so that it is rarely predictable with surveillance

Comparison of endoscopic and histo-pathologic findings should be performed

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None