Feasibility and Safety of Extraperitoneal Laparoscopic Extended Retroperitoneal Lymph Node Dissection at Time of Nephroureterectomy for Upper Tract Urothelial Carcinoma
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|ClinicalTrials.gov Identifier: NCT03544437|
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : October 16, 2018
|Condition or disease||Intervention/treatment|
|Upper Tract Urothelial Carcinoma||Procedure: extraperitoneal laparoscopic extended retroperitoneal lymph node dissection|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||40 participants|
|Target Follow-Up Duration:||3 Months|
|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|
|Actual Study Start Date :||May 21, 2018|
|Estimated Primary Completion Date :||December 30, 2018|
|Estimated Study Completion Date :||March 31, 2019|
- 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.
- Perioperative complications rate [ Time Frame: 90 days ]Perioperative complications were evaluated up to 90 days after surgery, and were graded by Clavien-Dindo classiﬁcation.
- Operating time [ Time Frame: during surgery ]Operating time
- Estimate blood loss [ Time Frame: during surgery ]Estimate blood loss during surgery
- length of stay [ Time Frame: 1 month ]The length of hospital stay
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03544437
|Contact: jiwei huang, M.D.||email@example.com|
|Renji Hospital, School of Medicine, Shanghai Jiao Tong University||Recruiting|
|Shanghai, Shanghai, China, 200123|
|Contact: Jiwei Huang, M.D|
|Principal Investigator:||Wei Xue, M.D||Renji Hospital, School of Medicine, Shanghai Jiao Tong University|