Bladder CancerNCT04358718
Influence of Opioids on Circulating Tumor Cells in Radical Cystectomy
A study testing general anesthesia and general anesthesia combined with epidural analgesia in people with Bladder Cancer, run by RenJi Hospital at 1 site in China.
Trial summary
Multiple lines of evidence have shown that perioperative opioids requirement was associated with poor outcomes in cancer patients, including increased cancer progression and metastases and reduced survival in patients with lung, breast, prostate, and bladder cancer. 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?
- general anesthesia and general anesthesia combined with epidural analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 2 Jun 2020to 21 Jan 2021
- 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
- Age >=18
- ASA I-II
- Patients with primary bladder cancer of Stage T2a or higher, who are scheduled for robot-assisted laparoscopic radical cystectomy
- Written informed consent
Who cannot join
- Emergency surgery
- Palliative surgery
- Contraindications for epidural anesthesia
- Metastatic bladder cancer
- Patients with a history of any other malignancy
- Chronic opioids medication
Show all 9Show fewer
- severe systemic disease (heart, lung, kidney, or immune system)
- Known hypersensitivity or suspected allergy to intervention drugs
- Intellectual Disability
Trial locations and contacts
1 site in 1 country.
China1 site
Renji hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200127
About this study
Official title: Influence of Peri-operative Opioids on Circulating Tumor Cells in Patients Undergoing Robot-Assisted Laparoscopic Radical Cystectomy
Multiple lines of evidence have shown that perioperative opioids requirement was associated with poor outcomes in cancer patients, including increased cancer progression and metastases and reduced survival in patients with lung, breast, prostate, and bladder cancer. Circulating tumor cells (CTCs) have been validated as prognostic biomarkers of a number of cancers. The aim of this study is to investigate the effects of perioperative opioids on the number of CTCs in patients receiving robot-assisted laparoscopic radical cystectomy. The difference of the amounts of perioperative opioids is achieved by using general anesthesia combined with intravenous opioid-based analgesia intra- and post-operatively in one group and general analgesia combined with epidural ropivacaine-based analgesia in the other group.
- Conditions
- Bladder Cancer
- Being tested
- general anesthesia, general anesthesia combined with epidural analgesia
- Keywords
- Circulating tumor cells, Opioid, Epidural anesthesia, Radical cystectomy
- Medical subject headings
- Urinary Bladder Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general anesthesiaProcedure or surgery
Patients will receive intraoperative and postoperative intravenous opioid-based analgesia for robot-assisted laparoscopic radical cystectomy.
general anesthesia combined with epidural analgesiaProcedure or surgery
Patients will receive epidural ropivacaine-based analgesia for robot-assisted laparoscopic radical cystectomy.
| Study group | Role | What they receive |
|---|---|---|
| general anesthesia | Active comparator | Patients in this group will receive general anesthesia with intraoperative and postoperative intravenous opioid-based analgesia. Receives: Procedure: general anesthesia |
| general analgesia combined with epidural analgesia | Experimental | Patients in this group will receive combined epidural and general anesthesia with intraoperative and postoperative epidural ropivacaine-based analgesia. Receives: Procedure: general anesthesia combined with epidural analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of circulating tumor cells
The number of circulating tumor cells will be measured by collecting 5ml of venous blood sample.
Measured: on the 3rd day after surgery
Secondary outcomes (4)
the number of circulating tumor cells
The number of circulating tumor cells will be measured by collecting 5ml of venous blood sample.
Measured: immediately after the surgery
the number of circulating tumor cells
The number of circulating tumor cells will be measured by collecting 5ml of venous blood sample.
Measured: on the 30 day after surgery
Visual Analogue Scale
Pain intensity will be assessed using the Visual Analogue Scale, which ranges from 0 to 10, with a higher score indicating greater pain intensity at 24 hours after surgery.
Measured: at 24 hours after surgery
Visual Analogue Scale
Pain intensity will be assessed using the Visual Analogue Scale, which ranges from 0 to 10, with a higher score indicating greater pain intensity at 48 hours after surgery.
Measured: at 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start2 Jun 2020
- Primary completion21 Dec 2020
- Study completion21 Jan 2021
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 Bladder CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Tian, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358718
- Sponsor's protocol ID
- CTC20200417
- Status last verified
- Aug 2021
- First submitted
- 19 Apr 2020
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang X, Zhang S, Jin D, Luo J, Shi Y, Zhang Y, Wu L, Song Y, Su D, Pan Z, Chen H, Cao M, Yang C, Yu W, Tian J. mu-opioid receptor agonist facilitates circulating tumor cell formation in bladder cancer via the MOR/AKT/Slug pathway: a comprehensive study including randomized controlled trial. Cancer Commun (Lond). 2023 Mar;43(3):365-386. doi: 10.1002/cac2.12408. Epub 2023 Feb 5.
PubMed 36739595
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Peri-operative Opioids on Circulating Tumor Cells in Patients Undergoing Robot-Assisted Laparoscopic Radical Cystectomy
- ClinicalTrials.gov ID
- NCT04358718
- Acronym / sponsor ID
- CTC20200417
- Conditions
- Bladder Cancer
- Keywords
- Circulating tumor cells, Opioid, Epidural anesthesia, Radical cystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 21 Jan 2021 (actual)
- First posted
- 24 Apr 2020 (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.
Multiple lines of evidence have shown that perioperative opioids requirement was associated with poor outcomes in cancer patients, including increased cancer progression and metastases and reduced survival in patients with lung, breast, prostate, and bladder cancer. Circulating tumor cells (CTCs) have been validated as prognostic biomarkers of a number of cancers. The aim of this study is to investigate the effects of perioperative opioids on the number of CTCs in patients receiving robot-assisted laparoscopic radical cystectomy. The difference of the amounts of perioperative opioids is achieved by using general anesthesia combined with intravenous opioid-based analgesia intra- and post-operatively in one group and general analgesia combined with epidural ropivacaine-based analgesia in the other group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| general anesthesia | Active comparator | Procedure: general anesthesiaPatients in this group will receive general anesthesia with intraoperative and postoperative intravenous opioid-based analgesia. |
| general analgesia combined with epidural analgesia | Experimental | Procedure: general anesthesia combined with epidural analgesiaPatients in this group will receive combined epidural and general anesthesia with intraoperative and postoperative epidural ropivacaine-based analgesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >=18
- ASA I-II
- Patients with primary bladder cancer of Stage T2a or higher, who are scheduled for robot-assisted laparoscopic radical cystectomy
- Written informed consent
Key exclusion criteria (9 listed)
- Emergency surgery
- Palliative surgery
- Contraindications for epidural anesthesia
- Metastatic bladder cancer
- Patients with a history of any other malignancy
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 |
|---|---|---|
| general anesthesiaPatients will receive intraoperative and postoperative intravenous opioid-based analgesia for robot-assisted laparoscopic radical cystectomy. | Procedure or surgery | general anesthesia |
| general anesthesia combined with epidural analgesiaPatients will receive epidural ropivacaine-based analgesia for robot-assisted laparoscopic radical cystectomy. | Procedure or surgery | general analgesia combined with epidural analgesia |
Primary outcome
the number of circulating tumor cells
Time frame: on the 3rd day after surgery
The number of circulating tumor cells will be measured by collecting 5ml of venous blood sample.
4 secondary outcomes
the number of circulating tumor cells
Time frame: immediately after the surgery
the number of circulating tumor cells
Time frame: on the 30 day after surgery
Visual Analogue Scale
Time frame: at 24 hours after surgery
Visual Analogue Scale
Time frame: at 48 hours after surgery
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 9 Aug 2021.
- Derived from this study: PubMed 36739595Wang X, Zhang S, Jin D, Luo J, Shi Y, Zhang Y, Wu L, Song Y, Su D, Pan Z, Chen H, Cao M, Yang C, Yu W, Tian J. mu-opioid receptor agonist facilitates circulating tumor cell formation in bladder cancer via the MOR/AKT/Slug pathway: a comprehensive study including randomized controlled trial. Cancer Commun (Lond). 2023 Mar;43(3):365-386. doi: 10.1002/cac2.12408. Epub 2023 Feb 5.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing general anesthesia and general anesthesia combined with epidural analgesia in people with Bladder Cancer, 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 9 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 9 Aug 2021. 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?
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?
the number of circulating tumor cells (time frame: on the 3rd day after surgery). 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 NCT04358718, 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 9 Aug 2021.