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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-22

Study Completion Date

2023-02-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Lymph Node Dissection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Routine lymph node dissection (LND) during nephroureterectomy

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.

Group Type EXPERIMENTAL

Routine Template-based lymphadenectomy

Intervention Type PROCEDURE

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 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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

LND was carried out only in patients who have lymph nodes enlargement in preoperative imaging (e.g. CTU or enhanced MRI) or who were found lymph nodes enlargement during surgery

Interventions

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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.

Intervention Type PROCEDURE

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 (e.g. CTU or enhanced MRI) or who were found lymph nodes enlargement during surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No