Vascularised Sentinel Skin Flaps to Detect Rejection in Pancreas Transplantation

April 16, 2019 updated by: University of Oxford
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sentinel Skin Flap
Other: Sentinel skin flap
Donor-derived vascularised composite allograft (sentinel skin flap)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordant allograft rejection
Time Frame: 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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discordant rejection of the sentinel skin
Time Frame: 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.
12 months
Discordant rejection of the visceral allograft
Time Frame: 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.
12 months
Donor specific antibodies
Time Frame: 12 months
Development of de novo donor specific antibodies
12 months
Immunosuppression
Time Frame: 12 months
Total dose immunosuppression
12 months
Graft survival
Time Frame: 12 months
Pancreas allograft survival
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Investigators

  • Principal Investigator: Peter J Friend, University of Oxford

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2016

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

June 5, 2017

First Submitted That Met QC Criteria

June 7, 2017

First Posted (Actual)

June 12, 2017

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 15/SW/0333

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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