Prognostic Value of Lymph Node Dissection in Patients With Transitional Cell Carcinoma of the Upper Urinary Tract

Phase 2

• Conditions: Lymph Node Dissection
• Interventions: Procedure: Routine Template-based lymphadenectomy; Procedure: LND only for lymph nodes enlargement found in preoperative image or during surgery

• Registration Number: NCT03474926
• Lead Sponsor: RenJi Hospital

Brief Summary

Recent studies showed the therapeutic benefit of lymphadenectomy in advanced stage urothelial carcinoma of the upper urinary tract, but there is still a lack of prospective studies. Thus, the current guideline recommends lymph node dissection for invasive upper tract urothelial carcinoma (UTUC) on the basis of insufficient evidence. Also, the preoperative judgment of muscle invasive pathological stage T 2+,or N+ is difficult from preoperative imaging. In the investigators' clinical practice, the surgeons performed dissection of regional lymph nodes only in patients with enlargement of lymph nodes found in preoperative imaging or during surgery. The aim of this multi-institutional study was to examine the role of lymphadenectomy in urothelial carcinoma of the upper urinary tract.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-22
• Study First Submitted: 2018-02-27
• Study First Submitted QC: 2018-03-21
• Study First Posted: 2018-03-23
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-19
• Last Update Posted: 2018-05-22
• Primary Completion: 2023-02-22
• Study Completion: 2023-02-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 504

Inclusion Criteria

• clinically diagnosed with upper tract urothelial carcinoma
• have no distant metastasis
• have an Eastern Cooperative Oncology Group (ECOG) score 0 to 2
• expected to receive radical nephroureterectomy

Exclusion Criteria

• a prior history of bladder cancer
• administration of neoadjuvant chemotherapy
• deny to receive long term follow-up
• patients with contralateral UTUCs
• patients with synchronous muscle invasive bladder cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine lymph node dissection (LND) during nephroureterectomy	Routine Template-based lymphadenectomy	Template-based LND was carried out in all patients in this group. The anatomical extent of LND is described in previous study. Lymph node specimens were sampled "en bloc" with surrounding adipose tissue, and were sent to pathological examination as individual packets with the surrounding adipose tissue.
LND for lymph nodes enlargement found before or during surgery	LND only for lymph nodes enlargement found in preoperative image or during surgery	LND was carried out only in patients who have lymph nodes enlargement in preoperative imaging (CTU or enhanced MRI) or who were found lymph nodes enlargement during surgery.

Primary Outcome Measures

Name	Time	Method
Disease free survival	36 month	Disease free survival rate in the 36 month following nephroureterectomy

Secondary Outcome Measures

Name	Time	Method
Cancer specific survival	36 month	Cancer specific survival rate in the 36 month following nephroureterectomy
Overall survival	36 month	Overall survival rate in the 36 month following nephroureterectomy
The recurrence rate of bladder cancer in the 36 month following nephroureterectomy	36 month	The recurrence rate of bladder cancer in the 36 month following nephroureterectomy
Perioperative complications rate	90 day	Perioperative complications were evaluated up to 90 days after surgery, and were graded by Clavien-Dindo classification

Trial Locations

Locations (2)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China

Peking University First Hospital; 🇨🇳 Beijin, Beijin, China