Vascularised Sentinel Skin Flaps to Detect Rejection in Pancreas Transplantation

Pancreas Transplant Rejection Clinical Trial

Official title:

Vascularised Sentinel Skin Flaps to Detect Rejection in Pancreas Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03183258
• Other study ID #: 15/SW/0333
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 19, 2016
• Est. completion date: October 1, 2020

Study information

• Verified date: April 2019
• Source: University of Oxford
• Contact: James CH Barnes
• Phone: +447717707384
• Email: James.Barnes[@]nds.ox.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreas Transplant Rejection

Intervention

Other:
• Sentinel skin flap
Donor-derived vascularised composite allograft (sentinel skin flap)

Locations

Country	Name	City	State
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.	12 months
Secondary	Donor specific antibodies	Development of de novo donor specific antibodies	12 months
Secondary	Immunosuppression	Total dose immunosuppression	12 months
Secondary	Graft survival	Pancreas allograft survival	12 months