Clinical trial · Interventional
Influence of Opioids on Circulating Tumor Cells in Radical Cystectomy
Influence of Peri-operative Opioids on Circulating Tumor Cells in Patients Undergoing Robot-Assisted Laparoscopic Radical Cystectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| general anesthesia | Procedure | — | UNRESOLVED |
| general anesthesia combined with epidural analgesia | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- general anesthesia
- description
- Patients in this group will receive general anesthesia with intraoperative and postoperative intravenous opioid-based analgesia.
- interventionNames
- Procedure: general anesthesia
- type
- EXPERIMENTAL
- label
- general analgesia combined with epidural analgesia
- description
- Patients in this group will receive combined epidural and general anesthesia with intraoperative and postoperative epidural ropivacaine-based analgesia.
- interventionNames
- Procedure: general anesthesia combined with epidural analgesia
Primary outcomes (1)
- measure
- the number of circulating tumor cells
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Emergency surgery * Palliative surgery * Contraindications for epidural anesthesia * Metastatic bladder cancer * Patients with a history of any other malignancy * Chronic opioids medication * severe systemic disease (heart, lung, kidney, or immune system) * Known hypersensitivity or suspected allergy to intervention drugs * Intellectual Disability
References
Publications (1)
- DERIVEDWang 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. PMID 36739595