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

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

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.

Study Overview

• Status: Unknown
• Conditions: Upper Tract Urothelial Carcinoma
• Intervention / Treatment: Procedure: extraperitoneal laparoscopic extended retroperitoneal lymph node dissection

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.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200123
      • Recruiting
      • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
      • Contact: Jiwei Huang, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 76 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Principal Investigator: Wei Xue, M.D, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2018
• Primary Completion (Anticipated): December 30, 2018
• Study Completion (Anticipated): March 31, 2019

Study Registration Dates

• First Submitted: May 19, 2018
• First Submitted That Met QC Criteria: May 31, 2018
• First Posted (Actual): June 1, 2018

Study Record Updates

• Last Update Posted (Actual): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 14, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: lymph node dissection; upper tract urothelial carcinoma; nephroureterectomy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Transitional Cell
• Other Study ID Numbers: UTUC-LND collaboration 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No