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

Upper Tract Urothelial Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03544437
• Other study ID #: UTUC-LND collaboration 2
• Status: Recruiting
• Start date: May 21, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: October 2018
• Source: RenJi Hospital
• Contact: jiwei huang, M.D.
• Phone: 8613651682825
• Email: huangjiwei[@]renji.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 31, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Upper Tract Urothelial Carcinoma

Intervention

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 de?ned 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.

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative complications rate	Perioperative complications were evaluated up to 90 days after surgery, and were graded by Clavien-Dindo classi?cation.	90 days
Secondary	Operating time	Operating time	during surgery
Secondary	Estimate blood loss	Estimate blood loss during surgery	during surgery
Secondary	length of stay	The length of hospital stay	1 month