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

• Sponsor: University Hospital Tuebingen (Other)
• Overall Status: Completed
• CT.gov ID: NCT04633486
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Actual Duration (Months): 91.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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	Phase
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

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 15 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Endoscopically One-year Follow-up in Patients After Small-bowel Transplantation, Role of SASAKI Score
• Actual Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Nov 15, 2019
• Actual Study Completion Date: Nov 15, 2019

Outcome Measures

Primary Outcome Measures

1. Rate of congruent findings of zoom-endoscopy and pathological examinations [12 months]

   Reliability of zoom-endoscopy and pathological examinations

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• intestinal transplant recipients

Exclusion Criteria:

• younger age (< 16)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Tuebingen	Tuebingen		Germany	72076

Sponsors and Collaborators

• University Hospital Tuebingen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital Tuebingen
• ClinicalTrials.gov Identifier: NCT04633486
• Other Study ID Numbers: 829/2020BO2
• First Posted: Nov 18, 2020
• Last Update Posted: Nov 18, 2020
• Last Verified: Nov 1, 2020

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

Study Results

No Results Posted as of Nov 18, 2020