Influence of Opioids on Circulating Tumor Cells in Radical Cystectomy

Bladder Cancer Clinical Trial

Official title:

Influence of Peri-operative Opioids on Circulating Tumor Cells in Patients Undergoing Robot-Assisted Laparoscopic Radical Cystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04358718
• Other study ID #: CTC20200417
• Status: Completed
• Phase: N/A
• Start date: June 2, 2020
• Est. completion date: January 21, 2021

Study information

• Verified date: August 2021
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 21, 2021
• Est. primary completion date: December 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Neoplastic Cells, Circulating

Intervention

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

Locations

Country	Name	City	State
China	Renji hospital, School of Medicine, Shanghai Jiaotong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the number of circulating tumor cells	The number of circulating tumor cells will be measured by collecting 5ml of venous blood sample.	on the 3rd day after surgery
Secondary	the number of circulating tumor cells	The number of circulating tumor cells will be measured by collecting 5ml of venous blood sample.	immediately after the surgery
Secondary	the number of circulating tumor cells	The number of circulating tumor cells will be measured by collecting 5ml of venous blood sample.	on the 30 day after surgery
Secondary	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.	at 24 hours after surgery
Secondary	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.	at 48 hours after surgery