Influence of Opioids on Circulating Tumor Cells in Radical Cystectomy

NCT ID: NCT04358718

Last Updated: 2021-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-02

Study Completion Date

2021-01-21

Brief Summary

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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.

Detailed Description

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Conditions

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Bladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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general anesthesia

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

Group Type ACTIVE_COMPARATOR

general anesthesia

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

general anesthesia combined with epidural analgesia

Intervention Type PROCEDURE

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

Interventions

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general anesthesia

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

Intervention Type PROCEDURE

general anesthesia combined with epidural analgesia

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jie Tian

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Renji hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 36739595 (View on PubMed)

Other Identifiers

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CTC20200417

Identifier Type: -

Identifier Source: org_study_id

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