ABO-Incompatible Kidney Transplants Between Robot-Assisted vs. Open Surgery

NCT06287008 | Completed

• 1 other identifier: 2023-0085
• Study Type: observational
• Target: 239
• Locations: 1 country
• Sites: 1

Brief Summary

While robot-assisted kidney transplantation (RAKT) offers potential benefits such as minimal postoperative pain, better cosmesis, fewer wound infections, and shorter hospital stay, its efficacy in ABO-incompatible (ABO-i) KT compared to open KT (OKT) remains understudied. This study aims to compare ABO-i KT outcomes between RAKT and OKT. The study utilized data from 29 ABO-i RAKT and 210 ABO-i OKT cases performed at Asan Medical Center from October 2020 to February 2023. Univariate and multivariate analyses were performed to evaluate factors associated with a composite of biopsy-proven acute rejection (BPAR), de novo donor-specific antibodies (DSA), and overall graft failure.

Conditions

Kidney Transplantation

Keywords

robot-assisted kidney transplantation; ABO incompatible; biopsy-proven acute rejection; immunologically high-risk patients

Outcome Measures

Primary Outcomes (2)

• Graft survival

  allograft (kidney) survival

  1 year post-operative

• renal function

  renal function measured in terms of eGFR (Estimated Glomerular Filtration Rate)

  1 year post-operative

Secondary Outcomes (1)

• . A composite of biopsy-proven acute rejection, graft failure, and the development of de novo donor-specific antibodies

  1 year post-operative

Study Arms (2)

OKT

patients who underwent "open kidney transplantation"

RAKT

patients who underwent "robot-assisted kidney transplantation"

Procedure: robot-assisted kidney transplantation

Interventions

robot-assisted kidney transplantation PROCEDURE

The interventional surgery is a robot-assisted kidney transplantation and its efficacy will be measured against that of open kidney transplantation

RAKT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

study includes 210 patients who undergo ABOi-open kidney transplantation and 29 who undergo ABOi-robot assisted kidney transplantation

You may qualify if:

• Patient eligible for living donor ABO incompatible kidney transplantation
• Presenting an IsoAgglutinin immunoglobulin G titer (anti-A-B) between 1/8 and 1/128 before operation
• Patient older than 18 years and young than 80 years
• Patient able to sign an informed consent form

You may not qualify if:

• Patient with comorbidities or hypersensitivity that prevent desensitization protocols
• Women who are pregnant, or who may become pregnant or breastfeeding women
• Subjects under legal protection

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (1)

• Kim JM, Kwon HE, Ko Y, Jung JH, Kwon H, Kim YH, Shin S. A comparative study on outcomes of ABO-incompatible kidney transplants between robot-assisted vs. open surgery-propensity score-matched analysis: a retrospective cohort study. BMC Nephrol. 2024 Nov 14;25(1):410. doi: 10.1186/s12882-024-03842-1.

  PMID: 39543527 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum (5cc\~10cc)

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 24, 2024
• First Posted: February 29, 2024
• Study Start: October 1, 2020
• Primary Completion: September 30, 2023
• Study Completion: January 31, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

KR (1)