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

Primary Purpose

Diabetes Mellitus；Uremia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
simultaneous pancreas-kidney transplantation
Sponsored by
Second Affiliated Hospital of Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus；Uremia

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

the homolateral simultaneous pancreas and kidney transplantation

Arm 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.

Outcomes

Primary Outcome Measures

Patient survival & pancreas graft survival & renal graft survival
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.

Secondary Outcome Measures

Full Information

First Posted
August 6, 2022
Last Updated
August 10, 2022
Sponsor
Second Affiliated Hospital of Guangzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05497232
Brief Title
Clinical Analysis of Simultaneous Pancreas-kidney Transplantation for End-stage Renal Disease Associated With Diabetes Mellitus
Official Title
Clinical Analysis of Simultaneous Pancreas-kidney Transplantation for End-stage Renal Disease Associated With Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Guangzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus；Uremia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the homolateral simultaneous pancreas and kidney transplantation
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
simultaneous pancreas-kidney transplantation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient survival & pancreas graft survival & renal graft survival
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of Diabetes patients with end-stage renal disease; First time receiving SPKT; Exclusion Criteria: Pulmonary infection, urinary tract infection, hematuria CMV or BK virus infection occurred during treatment; Using a large number of abnormal biological products (blood transfusion, plasma or coagulation factors) may contain foreign DNA; Loss of graft due to thrombosis or AR; Patients who are pregnant or have malignant tumors or patients with a history of cell therapy, whose tumor signals interfere with dd-cfDNA detection; Patients who have poor compliance during treatment or suffer from mental illness.
Facility Information:
Facility Name
1Department of Organ Transplantation, Second Affiliated Hospital of Guangzhou Medical University,
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luhao liu, Dr
Phone
+86 15521117553
Email
liuluhao2011@163.com
First Name & Middle Initial & Last Name & Degree
zheng Chen, prof.
Phone
+86 13808896300
Email
docchenzheng@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
yes

Learn more about this trial

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

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