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

NCT ID: NCT03544437

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-21
• Study Completion Date: 2019-03-31

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.

Conditions

Upper Tract Urothelial Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Xue, M.D

Role: PRINCIPAL_INVESTIGATOR

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Locations

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

jiwei huang, M.D.

Role: CONTACT

huangjiwei@renji.com

8613651682825

Facility Contacts

Jiwei Huang, M.D

Role: primary

References

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.

Reference Type: DERIVED

PMID: 35280720 (View on PubMed)

Other Identifiers

UTUC-LND collaboration 2

Identifier Type: -

Identifier Source: org_study_id