Feasibility and Safety of Extraperitoneal Laparoscopic Extended Retroperitoneal Lymph Node Dissection at Time of Nephroureterectomy for Upper Tract Urothelial Carcinoma

Study Overview
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Brief Summary
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Extended pelvic lymph node dissection in bladder carcinoma provides staging and, in selected patients, a survival beneﬁt. Recent studies showed the therapeutic beneﬁt of retroperitoneal lymph node dissection (RPLND) in advanced stage of upper tract urothelial carcinoma (UTUC). Also laparoscopic extended RPLND is still a technical challenge in urology, considering the high rate of severe complications and difﬁculties in manipulation. In Renji Hospital, laparoscopic extended RPLND at time of nephroureterectomy was performed via an extraperitoneal approach, avoiding interference with abdominal organs and achieving better exposure.The aim of the present study was to determine the safety and feasibility of performing an extraperitoneal laparoscopic extended RPLND at the time of radical nephroureterectomy (RNU) for UTUC in a prospectively collected cohort of patients.

Detailed Description
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Similar to urothelial carcinoma of the bladder (UCB), UTUC can follow routes of metastases to involve regional lymph nodes. Nodal metastasis is an adverse prognostic indicator and results in poor outcome, irrespective of the use of systemic chemotherapy or radiation. The ' gold standard ' treatment for UUT-UC is RNU. Extended pelvic lymph node dissection in bladder carcinoma provides staging and, in selected patients, a survival beneﬁt. Recent studies showed the therapeutic beneﬁt of RPLND 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 UCUT on the basis of insufﬁcient evidence. But no prospective studies have standardized the ideal extent of RPLND or the optimum number of total lymph nodes that should be removed in patients with UUT-UC. Also more and more interest has been paid to establish standardized node dissection templates. Also laparoscopic extended RPLND is still a technical challenge in urology, considering the high rate of severe complications and difﬁculties in manipulation. In Renji Hospital, laparoscopic extended RPLND at time of nephroureterectomy was performed via an extraperitoneal approach, avoiding interference with abdominal organs and achieving better exposure. The aim of the present study was to determine the safety and feasibility of performing an extraperitoneal laparoscopic extended RPLND at the time of RNU for UTUC in a prospectively collected cohort of patients.

Official Title
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Prospective Clinical Trial of the Feasibility and Safety of Extraperitoneal Laparoscopic Extended Retroperitoneal Lymph Node Dissection at Time of Nephroureterectomy for Upper Tract Urothelial Carcinoma

Conditions
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Upper Tract Urothelial Carcinoma

Intervention / Treatment
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* Procedure: extraperitoneal laparoscopic extended retroperitoneal lymph node dissection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinically diagnosed with upper tract urothelial carcinoma have no distant metastasis have an ECOG 0 to 2 expected to receive radical nephroureterectomy Exclusion Criteria: had no previous abdominal surgeries contra-indications to laparoscopic surgery (e.g. severe chronic obstructive pulmonary disease) patients with cT4 disease before surgery

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: extraperitoneal laparoscopic extended retroperitoneal lymph node dissection|All patients underwent extraperitoneal laparoscopic RNU with bladder cuff excision with concomitant extended RPLND performed by one of two urology surgeons at Renji Hospital. The anatomical boundaries of the lymph node dissection were deﬁned by the ipsilateral side of UUT-UC. In patients with right-sided UUT-UC, the template of dissection consisted of (i) right perihilar lymph nodes, (ii) paracaval lymph nodes, (iii) interaortocaval lymph nodes and (iv) right pelvic lymph nodes (common, external and obturator lymph nodes). In patients with left-sided UUT-UC, the template of dissection included (i) left perihilar lymph nodes, (ii) para-aortic lymph nodes, and (iii) left pelvic lymph nodes (common, external and obturator lymph nodes ). 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative complications rate | Perioperative complications were evaluated up to 90 days after surgery, and were graded by Clavien-Dindo classiﬁcation. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating time | Operating time | during surgery | 
| Estimate blood loss | Estimate blood loss during surgery | during surgery | 
| length of stay | The length of hospital stay | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lymph node dissection, upper tract urothelial carcinoma, nephroureterectomy