Vascularised Sentinel Skin Flaps to Detect Rejection in Pancreas Transplantation

Phase 1

• Conditions: Pancreas Transplant Rejection
• Interventions: Other: Sentinel skin flap

• Registration Number: NCT03183258
• Lead Sponsor: University of Oxford

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-05-19
• Study First Submitted: 2017-06-05
• Study First Submitted QC: 2017-06-07
• Study First Posted: 2017-06-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-17
• Primary Completion: 2019-10-01
• Study Completion: 2020-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sentinel Skin Flap	Sentinel skin flap	-

Primary Outcome Measures

Name	Time	Method
Concordant allograft rejection	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Discordant rejection of the visceral allograft	12 months	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.
Donor specific antibodies	12 months	Development of de novo donor specific antibodies
Immunosuppression	12 months	Total dose immunosuppression
Graft survival	12 months	Pancreas allograft survival
Discordant rejection of the sentinel skin	12 months	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.

Trial Locations

Locations (1)

Oxford University Hospitals NHS Foundation Trust; 🇬🇧 Oxford, United Kingdom