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

Sponsor
Second Affiliated Hospital of Guangzhou Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05497232
Collaborator
(none)
200
1
1
16
12.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: simultaneous pancreas-kidney transplantation
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Analysis of Simultaneous Pancreas-kidney Transplantation for End-stage Renal Disease Associated With Diabetes Mellitus
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Procedure: 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.

Outcome Measures

Primary Outcome Measures

  1. Patient survival & pancreas graft survival & renal graft survival [12 months]

    Renal graft survival was defined as the exclusion of graft resection, restoration of dialysis, and death with graft function. Survival of the transplanted pancreas excluded resection of the transplanted pancreas, recovery of preoperative insulin dosage and death with graft function.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 1Department of Organ Transplantation, Second Affiliated Hospital of Guangzhou Medical University, Guangzhou Guangdong China

Sponsors and Collaborators

  • Second Affiliated Hospital of Guangzhou Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier:
NCT05497232
Other Study ID Numbers:
  • 2022-hg-ks-17
First Posted:
Aug 11, 2022
Last Update Posted:
Aug 11, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2022