Influence of Opioids on Circulating Tumor Cells in Radical Cystectomy

Sponsor

RenJi Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04358718

Collaborator

(none)

Enrollment

Location

Arms

7.7

Actual Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Procedure: general anesthesia Procedure: general anesthesia combined with epidural analgesia	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 2, 2020

Actual Primary Completion Date :

Dec 21, 2020

Actual Study Completion Date :

Jan 21, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: general anesthesia Patients in this group will receive general anesthesia with intraoperative and postoperative intravenous opioid-based analgesia.	Procedure: general anesthesia Patients will receive intraoperative and postoperative intravenous opioid-based analgesia for robot-assisted laparoscopic radical cystectomy.
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.	Procedure: general anesthesia combined with epidural analgesia Patients will receive epidural ropivacaine-based analgesia for robot-assisted laparoscopic radical cystectomy.

Arm

Intervention/Treatment

Active Comparator: general anesthesia

Patients in this group will receive general anesthesia with intraoperative and postoperative intravenous opioid-based analgesia.

Procedure: general anesthesia

Patients will receive intraoperative and postoperative intravenous opioid-based analgesia for robot-assisted laparoscopic radical cystectomy.

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.

Procedure: general anesthesia combined with epidural analgesia

Patients will receive epidural ropivacaine-based analgesia for robot-assisted laparoscopic radical cystectomy.

Outcome Measures

Primary Outcome Measures

the number of circulating tumor cells [on the 3rd day after surgery]
The number of circulating tumor cells will be measured by collecting 5ml of venous blood sample.

Secondary Outcome Measures

the number of circulating tumor cells [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Renji hospital, School of Medicine, Shanghai Jiaotong University	Shanghai	Shanghai	China	200127

Sponsors and Collaborators

RenJi Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jie Tian, Principal Investigator, RenJi Hospital

ClinicalTrials.gov Identifier:

NCT04358718

Other Study ID Numbers:

CTC20200417

First Posted:

Apr 24, 2020

Last Update Posted:

Aug 9, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jie Tian, Principal Investigator, RenJi Hospital

Circulating tumor cells

Opioid

Epidural anesthesia

Radical cystectomy

Additional relevant MeSH terms:

Neoplastic Cells, Circulating

Anesthetics

Study Results

No Results Posted as of Aug 9, 2021