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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sentinel Skin Flap | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sentinel skin flap | Other | Donor-derived vascularised composite allograft (sentinel skin flap) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Discordant rejection of the sentinel skin | If there is any clinical suspicion of rejection then both the sentinel skin flap and visceral allograft will be biopsied. Discordant rejection will be recorded where there is rejection of the sentinel skin without rejection of the visceral allograft. | 12 months |
| Discordant rejection of the visceral allograft |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James CH Barnes | Contact | +447717707384 | James.Barnes@nds.ox.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Peter J Friend | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford University Hospitals NHS Foundation Trust | Recruiting | Oxford | OX3 7LE | United Kingdom |
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If there is any clinical suspicion of rejection then both the sentinel skin flap and visceral allograft will be biopsied. Discordant rejection will be recorded where there is rejection of the visceral allograft without rejection of the sentinel skin. |
| 12 months |
| Donor specific antibodies | Development of de novo donor specific antibodies | 12 months |
| Immunosuppression | Total dose immunosuppression | 12 months |
| Graft survival | Pancreas allograft survival | 12 months |