Upper Tract Urothelial CarcinomaNCT03544437
Feasibility and Safety of Extraperitoneal Laparoscopic Extended Retroperitoneal Lymph Node Dissection at Time of Nephroureterectomy for Upper Tract Urothelial Carcinoma
An observational study of Upper Tract Urothelial Carcinoma, run by RenJi Hospital at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Upper Tract Urothelial Carcinoma
- What is being tested?
- extraperitoneal laparoscopic extended retroperitoneal lymph node dissection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2018to 31 Mar 2019
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- clinically diagnosed with upper tract urothelial carcinoma
- have no distant metastasis
- have an ECOG 0 to 2
- expected to receive radical nephroureterectomy
Who cannot join
- had no previous abdominal surgeries
- contra-indications to laparoscopic surgery (e.g. severe chronic obstructive pulmonary disease)
- patients with cT4 disease before surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200123
Jiwei Huang, M.D
About this study
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
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.
Read the 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
- Being tested
- extraperitoneal laparoscopic extended retroperitoneal lymph node dissection
- Keywords
- lymph node dissection, upper tract urothelial carcinoma, nephroureterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extraperitoneal laparoscopic extended retroperitoneal lymph node dissectionProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative complications rate
Perioperative complications were evaluated up to 90 days after surgery, and were graded by Clavien-Dindo classification.
Measured: 90 days
Secondary outcomes (3)
Operating time
Operating time
Measured: during surgery
Estimate blood loss
Estimate blood loss during surgery
Measured: during surgery
length of stay
The length of hospital stay
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start21 May 2018
- Primary completion30 Dec 2018 (estimated)
- Study completion31 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Tract Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Xue, M.D, Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544437
- Sponsor's protocol ID
- UTUC-LND collaboration 2
- Status last verified
- Oct 2018
- First submitted
- 19 May 2018
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35280720
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03544437
- Acronym / sponsor ID
- UTUC-LND collaboration 2
- Conditions
- Upper Tract Urothelial Carcinoma
- Keywords
- lymph node dissection, upper tract urothelial carcinoma, nephroureterectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 21 May 2018 (actual)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 1 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- clinically diagnosed with upper tract urothelial carcinoma
- have no distant metastasis
- have an ECOG 0 to 2
- expected to receive radical nephroureterectomy
Key exclusion criteria (3 listed)
- had no previous abdominal surgeries
- contra-indications to laparoscopic surgery (e.g. severe chronic obstructive pulmonary disease)
- patients with cT4 disease before surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extraperitoneal laparoscopic extended retroperitoneal lymph node dissectionAll 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. | Procedure or surgery | – |
Primary outcome
Perioperative complications rate
Time frame: 90 days
Perioperative complications were evaluated up to 90 days after surgery, and were graded by Clavien-Dindo classification.
3 secondary outcomes
Operating time
Time frame: during surgery
Estimate blood loss
Time frame: during surgery
length of stay
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Derived from this study: PubMed 35280720Huang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Xue, M.D principal investigator
Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Tract Urothelial Carcinoma, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jiwei huang, M.D. (8613651682825, huangjiwei@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative complications rate (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03544437, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.