Relationship Between Lymph Node Dissection and Prognosis in High-risk NMIBC

  • STATUS
    Recruiting
  • End date
    Jun 30, 2028
  • participants needed
    200
  • sponsor
    The First Affiliated Hospital with Nanjing Medical University
Updated on 24 November 2021
radical cystectomy
neutrophil count
invasive bladder cancer
transurethral resection
bladder tumor
transurethral bladder excision

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.

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-nave, 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.

Details
Condition Urothelial Cancer, Bladder Cancer, urinary tract neoplasm, bladder cancer, Bladder Carcinoma, Urologic Cancer, carcinoma of the bladder, Bladder Disorders, bladder disorder, bladder tumor
Treatment Reduce surgical procedures
Clinical Study IdentifierNCT05123625
SponsorThe First Affiliated Hospital with Nanjing Medical University
Last Modified on24 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients who did not undergo diagnostic transurethral resection of bladder tumor (TURBT): biopsy suggestive of G3/high grade or with CIS or cystoscopic findings of multiple, tumor diameter greater than 3 cm; and VI-RADS score of 1 or 2; and no enlarged lymph nodes detected by MRI
Patients undergoing diagnostic TURBT: pathologically confirmed high-risk NMIBC, a) stage T1; b) G3 or high-grade; c) CIS; d) multiple, recurrent TaG1G2/low-grade bladder cancer patients with >3 cm in diameter. And no enlarged lymph nodes detected on MRI
Benefit from radical cystectomy as assessed by the investigator
Meeting the indications for the procedure: a) absolute neutrophil count 1.5 109/L
platelets 100 109/L; c) hemoglobin 90 g/L; d) international normalized ratio or activated partial thromboplastin time 1.5 upper limit of normal (ULN); e) calculated creatinine clearance 1 ml/s f) serum total bilirubin 1.5 ULN; g) AST, ALT and alkaline phosphatase 2.5 ULN; h) cardiopulmonary function suggestive of tolerance to major abdominal surgery
No previous history of tumor, lymph node dissection, or immune system-related disease
Age 18 to 75 years
No neoadjuvant therapy
ECOG physical status 0 or 1
Voluntary participation in this trial, ability to provide written informed consent, and understanding and agreement to comply with the requirements of this study and the evaluation schedule

Exclusion Criteria

Patients with bladder cancer T2N0M0 confirmed by pathology or assessed by imaging, or with pelvic lymph node enlargement indicated by MRI
The investigator assessed patients who could not tolerate radical cystectomy
Previous systemic chemotherapy or immunotherapy
The presence of active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of large amounts of hormones and other immunosuppressants
Had undergone major surgery or major trauma within 28 days before enrollment
Received live vaccine within 28 days before enrollment
Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy within 14 days prior to enrollment
Received any Chinese herbal medicine or proprietary Chinese medicine for cancer control within 14 days before enrollment
Participating in other clinical studies
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