NCT05123625

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Bladder cancer is highly prevalent worldwide and approximately 75% of these are non-muscle invasive bladder cancer (NMIBC). For high-risk NMIBC, postoperative intravesical chemotherapy combined with full-dose BCG for 3 years is recommended. Radical cystectomy (RC) is also one of the treatment options, and is recommended for patients with BCG-naïve, BCG-refractory, and recurrent high-grade or carcinoma-in-situ (CIS) bladder cancer after BCG perfusion. RC combined with pelvic lymph node dissection is the standard treatment for MIBC. Currently, there is no conclusion on the radical treatment of NMIBC, most of NMIBC patients refer to MIBC and also perform pelvic lymph node dissection. However, long operation time, high incidence of lymphatic cyst, lymphatic leakage and other complications, and long recovery time, increase the psychological and economic burden. At present, many studies have showed that the positive rate of lymph nodes in NMIBC patients is low. Investigators also analyzed the data of patients who underwent RC in investigators' center from 2013 to 2019, and found that the positive rate of lymph nodes in 163 NMIBC patients was only 3.07%. MRI can effectively predict pelvic metastatic lymph nodes, and its sensitivity and negative predictive values have been reported as high as 76.4% and 71.4%. VI-RADS score can effectively judge the muscularity of bladder tumor. Therefore, Investigators proposed whether it is necessary to perform pelvic lymph node dissection in NMIBC patients without enlarged lymph nodes indicated by pelvic MRI. Investigators intended to divide participants at high risk of NMIBC without enlarged lymph nodes as indicated by pelvic MRI into two groups 1:1. One group underwent RC combined with lymph node dissection and the other group only underwent RC. The incidence of complications and PFS/OS at 1, 3, and 5 years were compared.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-07-01
• Primary completion: 2027-06-30
• Completion: 2028-06-30
• First posted: 2021-11-17
• Last updated: 2025-08-05

Locations

1 site across 1 country: China