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Anesthesia and Cancer Study: Renal Cell Carcinoma

Primary Purpose

Renal Cell Carcinoma

Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Propofol
Inhaled General Anesthetics
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Renal Cell Carcinoma focused on measuring Anesthesia, Propofol, Inhaled anesthetics, Renal cell carcinoma, Nephrectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients scheduled for elective nephrectomy due to renal cell carcinoma

Exclusion Criteria:

  • Emergency surgery
  • Pregnancy
  • Allergies to anesthetics
  • Palliative surgery
  • Refusal to participate in the study
  • History of diagnosis or surgery for other cancer

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TIVA group

inhalation group

Arm Description

Patients receiving the total intravenous anesthesia using propofol

Patients receiving inhalation anesthesia using sevoflurane or desflurane

Outcomes

Primary Outcome Measures

one year metastasis-free survival
one year metastasis-free survival

Secondary Outcome Measures

three year metastasis-free survival
three year metastasis-free survival
one year survival
survival rate regardless of recurrence
three year survival
survival rate regardless of recurrence

Full Information

First Posted
August 3, 2020
Last Updated
April 12, 2023
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04503148
Brief Title
Anesthesia and Cancer Study: Renal Cell Carcinoma
Official Title
The Influence of Type of Anesthesia on Recurrence of Renal Cell Carcinoma After Nephrectomy: a Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 22, 2020 (Actual)
Primary Completion Date
December 22, 2022 (Actual)
Study Completion Date
December 22, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study investigates the influence of type of anesthesia on recurrence and survival of renal cell carcinoma in patients undergoing nephrectomy. The participants will be allocated to either the group receiving the total intravenous anesthesia (TIVA) using propofol or the group receiving the inhaled anesthetics, such as sevoflurane or desflurane.
Detailed Description
The effect of anesthesia on cancer recurrence and survival is controversial. According to some retrospective studies and preclinical studies, TIVA is suggested to be more favorable than inhalation anesthesia regarding cancer recurrence and survival after surgery. However, to our knowledge, there is no study which investigates the influence of type of anesthesia on recurrence of renal cell carcinoma after nephrectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
Anesthesia, Propofol, Inhaled anesthetics, Renal cell carcinoma, Nephrectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective randomized controlled study
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
562 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TIVA group
Arm Type
Experimental
Arm Description
Patients receiving the total intravenous anesthesia using propofol
Arm Title
inhalation group
Arm Type
Active Comparator
Arm Description
Patients receiving inhalation anesthesia using sevoflurane or desflurane
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Propofol 1-2 mg/kg bolus injection for induction of anesthesia propofol continuous infusion for maintenance of anesthesia
Intervention Type
Drug
Intervention Name(s)
Inhaled General Anesthetics
Intervention Description
Sevoflurane or desflurane for induction and maintenance of anesthesia
Primary Outcome Measure Information:
Title
one year metastasis-free survival
Description
one year metastasis-free survival
Time Frame
one years after surgery
Secondary Outcome Measure Information:
Title
three year metastasis-free survival
Description
three year metastasis-free survival
Time Frame
three years after surgery
Title
one year survival
Description
survival rate regardless of recurrence
Time Frame
one year after surgery
Title
three year survival
Description
survival rate regardless of recurrence
Time Frame
three year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients scheduled for elective nephrectomy due to renal cell carcinoma Exclusion Criteria: Emergency surgery Pregnancy Allergies to anesthetics Palliative surgery Refusal to participate in the study History of diagnosis or surgery for other cancer
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Anesthesia and Cancer Study: Renal Cell Carcinoma

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