Bladder CancerLBOACPNCT05939856
Lymph Node Dissection Before or After Cystectomy
A study testing Lymph node dissection before bladder resection and Lymph node dissection after bladder resection in people with Bladder Cancer, run by Jagiellonian University at 1 site in Poland.
Trial summary
The purpose of this study is to compare different ways of performing surgery for bladder cancer. Specifically, the goal is to determine whether it is better to remove the lymph nodes before removing the bladder or after removing the bladder during radical cystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Lymph node dissection before bladder resection and Lymph node dissection after bladder resection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 27 Jul 2023to 23 Jun 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing radical cystectomy for bladder cancer in the Department of Urology University Hospital in Krakow
Who cannot join
- Previous pelvic lymph node dissection
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Urology, University Hospital, Jagiellonian University
Krakow, 30-688
About this study
Official title: Lymph Node Dissection Before or After Cystectomy - Pilot Randomized Controlled Trial
The purpose of this study is to compare different ways of performing surgery for bladder cancer. Specifically, the goal is to determine whether it is better to remove the lymph nodes before removing the bladder or after removing the bladder during radical cystectomy.
The study aims to answer two main questions:
Read more
- Does the order of surgical steps during radical cystectomy affect the occurrence of complications after surgery?
- Does the order of surgical steps during radical cystectomy impact the duration of the operation and the number of lymph nodes removed?
Participants in the study will be randomly assigned to one of two groups. One group will undergo lymph node removal before bladder resection, while the other group will have lymph node removal after bladder resection during radical cystectomy.
Throughout their hospital stay and for 30 days following the operation, participants will be closely monitored for various factors including operative details, pathology results, and any complications that may arise.
Read the detailed description
Lymph node dissection (LND) is an integral part of radical cystectomy (RC) for bladder cancer. LND provides important diagnostic and prognostic information, and according to most studies, is associated with therapeutic benefit. The optimal extent and template for LND in bladder cancer remains to be established. Currently, there are no specific recommendations regarding the sequence of lymph nodes removal and bladder resection during radical cystectomy, and the decision is based mainly on individual surgeon preference.
The aim of the LBOAC pilot randomized trial is to evaluate the difference in intraoperative parameters and postoperative outcomes between patients undergoing LND before bladder resection during RC and those undergoing LND after bladder resection during RC.
LBOAC is a pilot randomized controlled trial with two parallel groups. The primary objective of the trial is the comparison of complication rate within 30 postoperative days. Secondary objectives of LBOAC include comparing lymph node yield and operative time between the two groups.
Data for will be collected using electronic case report forms (eCRFs) at baseline and within 30 days after the surgery.
This pilot study is designed to test feasibility of, to support the refinements of the protocol and to aid in sample calculation that can be used for larger scale trial.
- Conditions
- Bladder Cancer
- Being tested
- Lymph node dissection before bladder resection, Lymph node dissection after bladder resection
- Keywords
- Bladder Cancer, Muscle-invasive bladder cancer, Radical cystectomy, Lymph node dissection
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymph node dissection before bladder resectionOther
Lymph node dissection before bladder resection
Lymph node dissection after bladder resectionOther
Lymph node dissection after bladder resection
| Study group | Role | What they receive |
|---|---|---|
| 1 Lymph node dissection before bladder resection | Other | Lymph node dissection will be performed before bladder resection during radical cystectomy Receives: Other: Lymph node dissection before bladder resection |
| 2 Lymph node dissection after bladder resection | Other | Lymph node dissection will be performed after bladder resection during radical cystectomy Receives: Other: Lymph node dissection after bladder resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early complications rate
Complications rate within 30 postoperative days
Measured: Within 30 days after the surgery
Secondary outcomes (2)
Lymph node yield
Number of lymph nodes removed
Measured: When pathology report is available (on average, the pathology report is available within 14 days after the surgery)
Operative time
Total operative time, bladder resection time, lymph node dissection time
Measured: At the end of the surgery (after the completion of skin closure and wound dressing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start27 Jul 2023
- Primary completion23 Jun 2024
- Study completion23 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna K. Czech, MD, Jagiellonian University
- Investigators
- Anna K. Czech, Principal investigator, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939856
- Sponsor's protocol ID
- LBOACPUJ
- Acronym
- LBOACP
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2023
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymph Node Dissection Before or After Cystectomy - Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05939856
- Acronym / sponsor ID
- LBOACP / LBOACPUJ
- Conditions
- Bladder Cancer
- Keywords
- Bladder Cancer, Muscle-invasive bladder cancer, Radical cystectomy, Lymph node dissection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 23 Jun 2024 (actual)
- Study completion
- 23 Jun 2024 (actual)
- First posted
- 11 Jul 2023 (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.
The purpose of this study is to compare different ways of performing surgery for bladder cancer. Specifically, the goal is to determine whether it is better to remove the lymph nodes before removing the bladder or after removing the bladder during radical cystectomy.
The study aims to answer two main questions:
- Does the order of surgical steps during radical cystectomy affect the occurrence of complications after surgery?
- Does the order of surgical steps during radical cystectomy impact the duration of the operation and the number of lymph nodes removed?
Participants in the study will be randomly assigned to one of two groups. One group will undergo lymph node removal before bladder resection, while the other group will have lymph node removal after bladder resection during radical cystectomy.
Throughout their hospital stay and for 30 days following the operation, participants will be closely monitored for various factors including operative details, pathology results, and any complications that may arise.
Detailed description
Lymph node dissection (LND) is an integral part of radical cystectomy (RC) for bladder cancer. LND provides important diagnostic and prognostic information, and according to most studies, is associated with therapeutic benefit. The optimal extent and template for LND in bladder cancer remains to be established. Currently, there are no specific recommendations regarding the sequence of lymph nodes removal and bladder resection during radical cystectomy, and the decision is based mainly on individual surgeon preference.
The aim of the LBOAC pilot randomized trial is to evaluate the difference in intraoperative parameters and postoperative outcomes between patients undergoing LND before bladder resection during RC and those undergoing LND after bladder resection during RC.
LBOAC is a pilot randomized controlled trial with two parallel groups. The primary objective of the trial is the comparison of complication rate within 30 postoperative days. Secondary objectives of LBOAC include comparing lymph node yield and operative time between the two groups.
Data for will be collected using electronic case report forms (eCRFs) at baseline and within 30 days after the surgery.
This pilot study is designed to test feasibility of, to support the refinements of the protocol and to aid in sample calculation that can be used for larger scale trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Lymph node dissection before bladder resection | Other | Other: Lymph node dissection before bladder resectionLymph node dissection will be performed before bladder resection during radical cystectomy |
| 2 Lymph node dissection after bladder resection | Other | Other: Lymph node dissection after bladder resectionLymph node dissection will be performed after bladder resection during radical cystectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing radical cystectomy for bladder cancer in the Department of Urology University Hospital in Krakow
Key exclusion criteria (1 listed)
- Previous pelvic lymph node dissection
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 |
|---|---|---|
| Lymph node dissection before bladder resectionLymph node dissection before bladder resection | Other | 1 Lymph node dissection before bladder resection |
| Lymph node dissection after bladder resectionLymph node dissection after bladder resection | Other | 2 Lymph node dissection after bladder resection |
Primary outcome
Early complications rate
Time frame: Within 30 days after the surgery
Complications rate within 30 postoperative days
2 secondary outcomes
Lymph node yield
Time frame: When pathology report is available (on average, the pathology report is available within 14 days after the surgery)
Operative time
Time frame: At the end of the surgery (after the completion of skin closure and wound dressing)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- 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.
Anna K. Czech principal investigator
Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymph node dissection before bladder resection and Lymph node dissection after bladder resection in people with Bladder Cancer, run by Jagiellonian University at 1 site in Poland.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Dec 2024. 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early complications rate (time frame: Within 30 days after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2024.