Clinical Research Directory

Intramuscular Injection of Mashed Parathyroid Tissue Into a Forearm During Thyroid Surgery to Prevent Permanent Postoperative Parathyroid Insufficiency (IMIPAT Study) - a Prospective Multicentre Trial

Parathyroid insufficiency is a common complication in thyroid surgery and occurs in 6.6 to 24%. Up to 4.4% suffer from permanent hypoparathyroidism requiring life-time substitution of calcium and vitamin D in order to maintain a normal calcium homeostasis. To prevent permanent postoperative parathyroid insufficiency after thyroidectomy, devascularized parathyroid glands are re-implanted intramuscularly by standard. To achieve graft function, meticulous preparation and division of parathyroid tissue is necessary as a prerequisite for tissue nutrition by diffu-sion until a recapillarisation of the parathyroid fragments sets in. There are persistent controversies about the optimal technique for the autotransplantation. The injection of mashed parathyroid tissue into a muscle appears to be a fast, secure and easy tech-nique to provide a sufficient parathyroid hormone (PTH) production in cases of insufficient production of the glands left in-situ. The study is based on the hypothesis that intramuscular injection of mashed parathyroid tissue is a safe procedure that enables graft survival through diffusion and allows for the subsequent production of systemically measurable levels of parathyroid hormone (PTH). The intervention consists of injecting mashed parathyroid tissue into the brachioradialis muscle of the non-dominant arm. The primary objective is to evaluate this technique with respect to both local complications arising from the transplantation procedure and the functional performance of the graft over time. Outcome measures include the PTH gradient between the transplanted and non-transplanted arms, parathyroid hormone levels measured in the antecubital fossa of both arms, and calcium levels. The study population comprises 100 patients, and the trial is designed as a prospective multicentre study. The risk-benefit assessment indicates that the risks associated with participation-particularly local complications and potential graft malfunction-are expected to be low. In patients with familial or renal hyperparathyroidism, autotransplantation of small parathyroid fragments (approximately 1 mm in diameter) has been standard practice for decades. Additionally, the injection of mashed parathyroid tissue into the sternocleidomastoid muscle during surgery has been performed in many centers for years. However, that approach has the limitation that PTH originating from the graft cannot be reliably measured due to anatomical constraints.

Exploring the Application Value of New Magnetic Resonance Imaging Technologies in Non-invasive Quantitative Assessment of Graft Function After Liver Transplantation

Title: Exploring the Application Value of New Magnetic Resonance Imaging Technologies in Non-invasive Quantitative Assessment of Graft Function after Liver Transplantation Purpose of the Study: This study aims to investigate the value of new imaging technologies in assessing early graft function in patients who have undergone liver transplantation. By analyzing clinical, imaging, laboratory, and pathological data from liver transplant patients, the study seeks to establish a non-invasive method for diagnosing, evaluating treatment efficacy, and predicting outcomes related to graft function. Background: Liver transplantation is a critical treatment for end-stage liver disease and acute liver failure. While it significantly improves patients' quality of life and survival rates, complications such as graft dysfunction can occur post-surgery. Traditional methods for assessing graft function, including liver function tests, imaging studies (like ultrasound and CT), and biopsy, have limitations in sensitivity and specificity. Therefore, there is a need for safer, non-invasive techniques that can provide a comprehensive assessment of graft function. Study Design: Type: Prospective study Participants: 1000 liver transplant patients who meet specific inclusion criteria, such as undergoing MR imaging post-transplant. Exclusion Criteria: Patients with contraindications for MRI, such as implanted devices or claustrophobia. Methods: Participants will undergo MRI scans using advanced techniques like diffusion-weighted imaging (DWI) and dynamic contrast-enhanced MRI (DCE-MRI) to evaluate graft function. Clinical and laboratory data will also be collected for comprehensive analysis. Potential Benefits: This study aims to enhance the early detection of graft dysfunction, allowing for timely interventions that could improve patient outcomes and prolong graft survival. Risks and Safeguards: While there is a risk of privacy breaches regarding patient data, all information will be handled confidentially and used solely for research purposes. Patient identities will be protected throughout the study. Conclusion: The findings from this study could lead to improved non-invasive assessment methods for liver transplant patients, ultimately enhancing clinical decision-making and patient care.