Clinical Analysis of Simultaneous Pancreas-kidney Transplantation for End-stage Renal Disease Associated With Diabetes Mellitus

Second Affiliated Hospital of Guangzhou Medical University

Status: Enrolling

Conditions: Diabetes Mellitus；Uremia

Treatments: Procedure: simultaneous pancreas-kidney transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT05497232

2022-hg-ks-17

Details and patient eligibility

About

The first pancreas transplantation was performed in 1966, by 2015, more than 40,000 pancreas transplantation have been performed worldwide. Nevertheless, only several Chinese organ transplant centers carry out SPK because of surgery complications. simultaneous pancreas-kidney transplantation is a new and promising therapeutic option for the treatment for type 1 diabetes mellitus patients and end-stage renal disease. the preliminary treatment results are summarized to promote the further development of this work in China.

Full description

simultaneous pancreas-kidney transplantation using the surgical technique was performed in our department from September 2016 to January 2023 in the Department of Transplantation of the Second Affiliated Hospital of Guangzhou Medical University. Patients were followed up for 2 to 36 months to summarize the efficacy and complications. we examined the influence of SPK on patient and graft survivals.

Enrollment: 200 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Clinical diagnosis of Diabetes patients with end-stage renal disease;
2. First time receiving SPKT;

Exclusion criteria

1. Pulmonary infection, urinary tract infection, hematuria CMV or BK virus infection occurred during treatment;
2. Using a large number of abnormal biological products (blood transfusion, plasma or coagulation factors) may contain foreign DNA;
3. Loss of graft due to thrombosis or AR;
4. Patients who are pregnant or have malignant tumors or patients with a history of cell therapy, whose tumor signals interfere with dd-cfDNA detection;
5. Patients who have poor compliance during treatment or suffer from mental illness.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

the homolateral simultaneous pancreas and kidney transplantation

Experimental group

Description:

SPK using the surgical technique was performed in our department from September 2016 to January 2023 in the Department of Transplantation of the Second Affiliated Hospital of Guangzhou Medical University.

Treatment:

Procedure: simultaneous pancreas-kidney transplantation