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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 2

Conditions: Lymph Node Dissection

Treatments: Procedure: LND only for lymph nodes enlargement found in preoperative image or during surgery; Procedure: Routine Template-based lymphadenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03474926

UTUC-LND collaboration 1

Details and patient eligibility

About

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.

Enrollment: 504 estimated patients

Sex: All

Ages: 15 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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504 participants in 2 patient groups

Routine lymph node dissection (LND) during nephroureterectomy

Experimental group

Description:

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.

Treatment:

Procedure: Routine Template-based lymphadenectomy

LND for lymph nodes enlargement found before or during surgery

Active Comparator group

Description:

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.

Treatment:

Procedure: LND only for lymph nodes enlargement found in preoperative image or during surgery