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

Sponsor
RenJi Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03544437
Collaborator
(none)
40
1
10.3
3.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Anticipated Primary Completion Date :
Dec 30, 2018
Anticipated Study Completion Date :
Mar 31, 2019

Outcome Measures

Primary Outcome Measures

  1. Perioperative complications rate [90 days]

    Perioperative complications were evaluated up to 90 days after surgery, and were graded by Clavien-Dindo classification.

Secondary Outcome Measures

  1. Operating time [during surgery]

    Operating time

  2. Estimate blood loss [during surgery]

    Estimate blood loss during surgery

  3. length of stay [1 month]

    The length of hospital stay

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Renji Hospital, School of Medicine, Shanghai Jiao Tong University Shanghai Shanghai China 200123

Sponsors and Collaborators

  • RenJi Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
RenJi Hospital
ClinicalTrials.gov Identifier:
NCT03544437
Other Study ID Numbers:
  • UTUC-LND collaboration 2
First Posted:
Jun 1, 2018
Last Update Posted:
Oct 16, 2018
Last Verified:
Oct 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by RenJi Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 16, 2018