Vascularised Sentinel Skin Flaps to Detect Rejection in Pancreas Transplantation
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Concordant allograft rejection
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Sentinel Skin Flap
干预措施: Sentinel skin flap (Other)
结局指标
主要结局
Concordant allograft rejection
时间窗: 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.
次要结局
- Immunosuppression(12 months)
- Discordant rejection of the visceral allograft(12 months)
- Donor specific antibodies(12 months)
- Discordant rejection of the sentinel skin(12 months)
- Graft survival(12 months)