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

NCT ID: NCT05497232

Last Updated: 2022-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-01-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitusï¼›Uremia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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the homolateral simultaneous pancreas and kidney transplantation

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.

Group Type EXPERIMENTAL

simultaneous pancreas-kidney transplantation

Intervention Type PROCEDURE

Renal transplants were performed to the right external iliac artery and vein, and the ureter was anastomosed to the recipient ureter by using end-to-end anastomoses techniques. All the renal allografts were placed into retroperitoneum.

Enteric drainage of exocrine secretions was performed on all pancreas transplants, systemic venous outflow (postcava), and arterial reconstruction with "y" graft (iliac artery). Lastly in all cases of renal transplant, the artery was anastomosed in all cases. The pancreas was placed intra-abdominally in all cases.

Interventions

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simultaneous pancreas-kidney transplantation

Renal transplants were performed to the right external iliac artery and vein, and the ureter was anastomosed to the recipient ureter by using end-to-end anastomoses techniques. All the renal allografts were placed into retroperitoneum.

Enteric drainage of exocrine secretions was performed on all pancreas transplants, systemic venous outflow (postcava), and arterial reconstruction with "y" graft (iliac artery). Lastly in all cases of renal transplant, the artery was anastomosed in all cases. The pancreas was placed intra-abdominally in all cases.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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1Department of Organ Transplantation, Second Affiliated Hospital of Guangzhou Medical University,

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Luhao liu, Dr

Role: primary

+86 15521117553

zheng Chen, prof.

Role: backup

+86 13808896300

Other Identifiers

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2022-hg-ks-17

Identifier Type: -

Identifier Source: org_study_id

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