NCT04358718

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

June 2, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2021

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

7 months

First QC Date

April 19, 2020

Last Update Submit

August 1, 2021

Conditions

Bladder Cancer

Keywords

Circulating tumor cellsOpioidEpidural anesthesiaRadical cystectomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • the number of circulating tumor cells

    immediately after the surgery

  • the number of circulating tumor cells

    on the 30 day after surgery

  • Visual Analogue Scale

    at 24 hours after surgery

  • Visual Analogue Scale

    at 48 hours after surgery

Study Arms (2)

general anesthesia

ACTIVE COMPARATOR

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

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.

Procedure: general anesthesia combined with epidural analgesia

Interventions

general anesthesiaPROCEDURE

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

general anesthesia
general anesthesia combined with epidural analgesiaPROCEDURE

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

general analgesia combined with epidural analgesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (1)

  • 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.

    PMID: 36739595DERIVED

MeSH Terms

Conditions

Urinary Bladder NeoplasmsNeoplastic Cells, Circulating

Interventions

Anesthesia, GeneralAnalgesia, Epidural

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaAnalgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 19, 2020

First Posted

April 24, 2020

Study Start

June 2, 2020

Primary Completion

December 21, 2020

Study Completion

January 21, 2021

Last Updated

August 9, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)