Vascularised Sentinel Skin Flaps to Detect Rejection in Pancreas Transplantation

University of Oxford20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Pancreas Transplant Rejection

Interventions

Sentinel skin flapOTHER

Donor-derived vascularised composite allograft (sentinel skin flap)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Locations (1)

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

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.

Time frame: 12 months

Discordant rejection of the visceral allograft

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.

Time frame: 12 months

Donor specific antibodies

Development of de novo donor specific antibodies

Time frame: 12 months

Immunosuppression

Total dose immunosuppression

Time frame: 12 months

Graft survival

Pancreas allograft survival

Time frame: 12 months

Central Contacts

James CH Barnes

CONTACT

+447717707384 James.Barnes@nds.ox.ac.uk

Data from ClinicalTrials.gov

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