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RECRUITING
NCT05123625
NA

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

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

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.

Official title: A Phase III Randomized Non-inferiority Multicenter Study of PLND Omission in Clinical NMIBC Undergoing Radical Cystectomy

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2021-07-01

Completion Date

2028-06-30

Last Updated

2025-08-05

Healthy Volunteers

No

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.

Locations (1)

The first affiliated hospital of Nanjing Medical University

Nanjing, Jiangsu, China