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Prognostic Effect of Whether Doing PLND During RC for High-risk NMIBC

NCT05123625 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-08-05

No results posted yet for this study

Summary

There is no consensus on the need for lymph node dissection in radical cystectomy (RC) for high-risk non-muscular invasive bladder cancer (NMIBC). Investigators divided participants at high risk of NMIBC without enlarged lymph nodes as indicated by pelvic MRI into two groups 1:1. One group of participants underwent RC combined with lymph node dissection and the other group of participants only underwent RC. The incidence of complications and PFS/OS at 1, 3, and 5 years were compared.

Conditions

Interventions

PROCEDURE

Reduce surgical procedures

In the intervention group, investigators used a reductive approach. That is, for radical cystectomy, investigators did not perform pelvic lymph node dissection.

Sponsors & Collaborators

  • The Second Affiliated Hospital of Kunming Medical University

    collaborator OTHER

  • Tianjin Medical University Second Hospital

    collaborator OTHER

  • RenJi Hospital

    collaborator OTHER

  • First Affiliated Hospital Xi'an Jiaotong University

    collaborator OTHER

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Qiang Lu, PhD · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2027-06-30
Completion
2028-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05123625 on ClinicalTrials.gov