Influence of Opioids on Circulating Tumor Cells in Radical Cystectomy

Overview

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.

Full Title of Study: “Influence of Peri-operative Opioids n Circulating Tumor Cells in Patients Undergoing Robot-Assisted Laparoscopic Radical Cystectomy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2020

Interventions

  • Procedure: general anesthesia
    • Patients will receive intraoperative and postoperative intravenous opioid-based analgesia for robot-assisted laparoscopic radical cystectomy.
  • Procedure: general anesthesia combined with epidural analgesia
    • Patients will receive epidural ropivacaine-based analgesia for robot-assisted laparoscopic radical cystectomy.

Arms, Groups and Cohorts

  • Active Comparator: general anesthesia
    • Patients in this group will receive general anesthesia with intraoperative and postoperative intravenous opioid-based analgesia.
  • Experimental: general analgesia combined with epidural analgesia
    • Patients in this group will receive combined epidural and general anesthesia with intraoperative and postoperative epidural ropivacaine-based analgesia.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • the number of circulating tumor cells
    • Time Frame: immediately after the surgery
    • The number of circulating tumor cells will be measured by collecting 5ml of venous blood sample.
  • the number of circulating tumor cells
    • Time Frame: on the 30 day after surgery
    • The number of circulating tumor cells will be measured by collecting 5ml of venous blood sample.
  • Visual Analogue Scale
    • Time Frame: at 24 hours after surgery
    • 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.
  • Visual Analogue Scale
    • Time Frame: at 48 hours after surgery
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • RenJi Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jie Tian, Principal Investigator – RenJi Hospital
  • Overall Contact(s)
    • Jie Tian, Ph.D., 86-21-68383702, vaseline2001@hotmail.com

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