Vascularised Sentinel Skin Flaps to Detect Rejection in Pancreas Transplantation
1 other identifier
interventional
20
1 country
1
Brief Summary
This pilot study aims to validate the use of vascularised donor-derived sentinel skin flaps for diagnosing rejection in pancreas transplantation. The aim of the study is to investigate the use of sentinel skin flaps in clinical practice and assess whether rejection occurs concordantly or discordantly between the skin flap and the transplanted abdominal organs. If successful, sentinel skin may allow improved immune surveillance and thereby facilitate earlier treatment of rejection with subsequent improvements in allograft survival and patient morbidity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2016
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 19, 2016
CompletedFirst Submitted
Initial submission to the registry
June 5, 2017
CompletedFirst Posted
Study publicly available on registry
June 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedApril 17, 2019
April 1, 2019
3.4 years
June 5, 2017
April 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Concordant allograft rejection
If there is any clinical suspicion of rejection then both the sentinel skin flap and visceral allograft will be biopsied. Concordant rejection will be recorded where rejection is confirmed in both the sentinel skin flap and the visceral allograft.
12 months
Secondary Outcomes (5)
Discordant rejection of the sentinel skin
12 months
Discordant rejection of the visceral allograft
12 months
Donor specific antibodies
12 months
Immunosuppression
12 months
Graft survival
12 months
Study Arms (1)
Sentinel Skin Flap
EXPERIMENTALInterventions
Donor-derived vascularised composite allograft (sentinel skin flap)
Eligibility Criteria
You may qualify if:
- Recipient of a pancreas transplant (SPK or PTA)
- Participant is willing and able to give informed consent for participation in the study
- Male or Female, aged 18 years or above
You may not qualify if:
- Patient does not have a patent ulna artery in either forearm
- Recipient of an enterically drained PTA
- Patient has received any investigational medical drug within 30 days of transplantation
- Patient is not willing to return to Oxford for all clinical follow-up for 12 months
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the trial, or the participant's ability to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LE, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Peter J Friend
University of Oxford
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2017
First Posted
June 12, 2017
Study Start
May 19, 2016
Primary Completion
October 1, 2019
Study Completion
October 1, 2020
Last Updated
April 17, 2019
Record last verified: 2019-04