Clinical trial NCT03544437: Feasibility and Safety of Extraperitoneal Laparoscopic Extended Retroperitoneal Lymph Node Dissection at Time of Nephroureterectomy for Upper Tract Urothelial Carcinoma
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Upper Tract Urothelial Carcinoma
Keywords: lymph node dissection
upper tract urothelial carcinoma
nephroureterectomy
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients who are clinically diagnosed with upper tract urothelial carcinoma and expected to receive radical nephroureterectomy will be the candidates for this study. They will be informed about this study and told about the pros and cons of extraperitoneal laparoscopic extended RPLND. If they were willing to attend this study, chest CT scan and other imaging method would be used to exclude out the distant metastasis.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Perioperative complications rate
timeFrame: 90 days
Secondary outcomes:
measure: Operating time
timeFrame: during surgery
measure: Estimate blood loss
timeFrame: during surgery
measure: length of stay
timeFrame: 1 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Wei Xue, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huang J, Qian H, Yuan Y, Cai X, Chen Y, Zhang J, Kong W, Wu X, Cao M, Huang Y, Chen H, Xue W. Prospective Clinical Trial of the Oncologic Outcomes and Safety of Extraperitoneal Laparoscopic Extended Retroperitoneal Lymph Node Dissection at Time of Nephroureterectomy for Upper Tract Urothelial Carcinoma. Front Oncol. 2022 Feb 24;12:791140. doi: 10.3389/fonc.2022.791140. eCollection 2022.