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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
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

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
Upper Tract Urothelial Carcinoma 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.



Primary Outcome Measures :
  1. Perioperative complications rate [ Time Frame: 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 [ Time Frame: during surgery ]
    Operating time

  2. Estimate blood loss [ Time Frame: during surgery ]
    Estimate blood loss during surgery

  3. length of stay [ Time Frame: 1 month ]
    The length of hospital stay



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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Contacts
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Contact: jiwei huang, M.D. 8613651682825 huangjiwei@renji.com

Locations
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China, Shanghai
Renji Hospital, School of Medicine, Shanghai Jiao Tong University Recruiting
Shanghai, Shanghai, China, 200123
Contact: Jiwei Huang, M.D         
Sponsors and Collaborators
RenJi Hospital
Investigators
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Principal Investigator: Wei Xue, M.D Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Additional Information:

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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT03544437     History of Changes
Other Study ID Numbers: UTUC-LND collaboration 2
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by RenJi Hospital:
lymph node dissection
upper tract urothelial carcinoma
nephroureterectomy

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms