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To Explore the Value of Magnetic Resonance Imaging in Noninvasive Quantitative Evaluation of Graft Function After Simultaneous Pancreas-kidney Transplantation

NCT07001917 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2025-06-03

No results posted yet for this study

Summary

Pancreatic kidney joint transplantation (SPK) has become the standard treatment for patients with diabetes complicated by end-stage renal disease. By simultaneously transplanting the pancreas and kidney, SPK can restore the patient\'s insulin secretion and kidney function after surgery, thereby significantly improving the patient\'s quality of life and extending life expectancy. However, the high incidence of postoperative complications, especially organ dysfunction, remains a major challenge. Complications of organ dysfunction include thrombosis of the pancreatic graft, acute rejection, graft pancreatitis, and acute tubular necrosis of the renal graft. Early diagnosis and monitoring of these complications are crucial for improving patient prognosis and extending the life of the transplanted organs.

Although some methods are currently used in clinical practice to assess graft function, such as estimated glomerular filtration rate (eGFR) and Gates method of renal dynamic imaging, these methods still have significant limitations. For example, traditional biochemical markers for predicting kidney function are affected by many irrelevant factors and lack accuracy. While the Gates method is widely used, its long examination process, high cost, and radiation exposure limit its feasibility in routine postoperative application. In addition, although tissue biopsy is considered the gold standard for assessing renal pathology, its invasiveness and potential complications limit its application. In view of the shortcomings of traditional methods, there is an urgent need for a non-invasive, dynamic, and accurate detection method for the early diagnosis of post-SPK organ dysfunction. Magnetic resonance imaging (MRI) has shown great potential in the assessment of transplanted organ function due to its non-invasiveness, high soft tissue resolution, and multi-parametric analysis capabilities. MRI can not only display the anatomical structure of the transplanted organs in detail but also dynamically monitor the blood perfusion and tissue oxygenation levels of the transplanted organs through advanced imaging techniques, such as arterial spin labeling (ASL) and blood oxygenation level-dependent (BOLD) imaging. The application of these new technologies helps to discover complications early and provides important diagnostic information, thereby improving patient prognosis. Therefore, this study aims to explore the application of MRI in the functional assessment of transplanted organs after SPK, especially its potential in the early diagnosis and monitoring of organ dysfunction. Through this study, we hope to provide a new non-invasive diagnostic method for the early discovery of post-SPK complications, thereby improving the long-term prognosis of patients and filling the gap in current clinical practice.

Conditions

  • Simultaneous Pancreas-Kidney Transplantation

Sponsors & Collaborators

  • Zhen Li

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-20
Primary Completion
2030-09-17
Completion
2030-12-12

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07001917 on ClinicalTrials.gov