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Recurrence free survival after hepatectomy using propofol-based anesthesia and sevoflurane-based anesthesia: a randomized controlled study

Status Approved

First Submitted Date

2019/10/23
Registered Date

2020/01/03
Last Updated Date

2021/04/09

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0004599
Unique Protocol ID	SMC 2019-10-093-002
Public/Brief Title	Recurrence free survival after hepatectomy using propofol-based anesthesia and sevoflurane-based anesthesia: a randomized controlled study
Scientific Title	Recurrence free survival after hepatectomy using propofol-based anesthesia and sevoflurane-based anesthesia: a randomized controlled study
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	SMC 2019-10-093-002
Approval Date	2019-12-26
Institutional Review Board Name	Samsung Medical Center
Institutional Review Board Address	81, Irwon-ro, Gangnam-gu, Seoul
Institutional Review Board Telephone	02-3410-2973
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Gaabsoo Kim
Title	MD.
Telephone	+82-2-3410-0360
Affiliation	Samsung Medical Center
Address	50, Irwon-Dong, Gangnam-Gu, 135-710, Seoul, Korea.
Contact Person for Public Queries
Name	Ji-Hye Kwon
Title	MD.
Telephone	+82-2-3410-0369
Affiliation	Samsung Medical Center
Address	50, Irwon-Dong, Gangnam-Gu, 135-710, Seoul, Korea.
Contact Person for Updating Information
Name	Ji-Hye Kwon
Title	MD.
Telephone	+82-2-3410-0369
Affiliation	Samsung Medical Center
Address	50, Irwon-Dong, Gangnam-Gu, 135-710, Seoul, Korea.

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2020-01-07 Actual
Target Number of Participant	536
Primary Completion Date	2024-12-31 , Anticipated
Study Completion Date	2024-12-31 , Anticipated
Name of Study	Samsung Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2020-01-07 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Samsung Medical Center
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Samsung Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	1) Purpose The purpose of this study is to evaluate the effect of anesthesia (propofol-based venous anesthesia vs. sevoflurane-based gas anesthesia) on the recurrence free survival (RFS) in patients undergoing liver resection for hepatocellular carcinoma. 2) Background Hepatocellular carcinoma is the fifth most common cancer worldwide and is known to have a poor prognosis. In South Korea, it is the first most common cancer among men and the fourth most common cause of cancer-related deaths. Surgical resection is the treatment of choice for HCC in non-cirrhotic patients and I patients with compensated cirrhosis. However, surgical stress leads to metabolic and neuroendocrine changes, which may cause significant suppression of cell-mediated immunity and may eventually stimulate implantation of circulating tumor cells. This potential combination of tumor seeding and impaired immune responses increases the susceptibility of patients undergoing cancer surgery to the development of metastasis, and is associated with worse long-term outcomes. The potential role of anesthetic drugs in the process of cancer recurrence has attracted interest. In particular, there have been reports that cancer recurrence rate and mortality rate were lower than those using gas anesthesia for propofol-based intravenous anesthesia. Most recently, a retrospective study of hepatocellular carcinoma reported the superiority of propofol-based intravenous anesthesia. These clinical reports are in line with the inflammatory and immune suppression effects of gas anesthetics and the anti-inflammatory and tumor growth and metastasis effects of gas anesthetics, which have been found in several animal and human cell line studies. In this study, a prospective randomized controlled trial was performed to determine whether anesthesia has a significant effect on the patient's prognosis in patients undergoing liver resection for HCC.

Study Summary Information

Lay Summary

1) Purpose
The purpose of this study is to evaluate the effect of anesthesia (propofol-based venous anesthesia vs. sevoflurane-based gas anesthesia) on the recurrence free survival (RFS) in patients undergoing liver resection for hepatocellular carcinoma.

2) Background
Hepatocellular carcinoma is the fifth most common cancer worldwide and is known to have a poor prognosis. In South Korea, it is the first most common cancer among men and the fourth most common cause of cancer-related deaths. Surgical resection is the treatment of choice for HCC in non-cirrhotic patients and I patients with compensated cirrhosis. However, surgical stress leads to metabolic and neuroendocrine changes, which may cause significant suppression of cell-mediated immunity and may eventually stimulate implantation of circulating tumor cells. This potential combination of tumor seeding and impaired immune responses increases the susceptibility of patients undergoing cancer surgery to the development of metastasis, and is associated with worse long-term outcomes. The potential role of anesthetic drugs in the process of cancer recurrence has attracted interest. In particular, there have been reports that cancer recurrence rate and mortality rate were lower than those using gas anesthesia for propofol-based intravenous anesthesia. Most recently, a retrospective study of hepatocellular carcinoma reported the superiority of propofol-based intravenous anesthesia. These clinical reports are in line with the inflammatory and immune suppression effects of gas anesthetics and the anti-inflammatory and tumor growth and metastasis effects of gas anesthetics, which have been found in several animal and human cell line studies. In this study, a prospective randomized controlled trial was performed to determine whether anesthesia has a significant effect on the patient&#39;s prognosis in patients undergoing liver resection for HCC.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Prevention
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Single
Blinded Subject	Subject, Outcome Accessor
Allocation	RCT
Intervention Type	Drug
Intervention Description	All study participants will undergo general anesthesia for surgery. Anesthesia is performed using propofol or sevoflurae, depending on the group. Remifentanil is used in both groups. The anesthesia and surgical procedures other than the agents used for induction and maintainenace are not different in both groups.
Number of Arms	2
Arm 1	Arm Label Propofol group
	Target Number of Participant 268
	Arm Type Experimental
	Arm Description 2 mg / kg of propofol to induce anesthesia is administered and anesthesia is maintained with propofol. The anesthesia and surgical procedures other than the agents used for induction and maintainenace are the same in both groups. Remifentanil is used in both groups from the beginning of anesthesia and can be discontinued when hypotension occurs.
Arm 2	Arm Label Sevoflurane group
	Target Number of Participant 268
	Arm Type Active comparator
	Arm Description 5 mg / kg of thiopental to induce anesthesia is administered and anesthesia is maintained with sevoflurane. The anesthesia and surgical procedures other than the agents used for induction and maintainenace are the same in both groups. Remifentanil is used in both groups from the beginning of anesthesia and can be discontinued when hypotension occurs.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (C00-D48)Neoplasms (C22.0)Malignant neoplasm of liver cell carcinoma Patients undergoing hepatectomy to treat hepatocellular carcinoma
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 18Year~75Year
	Description -Adults who undergo elective hepatectomy for hepatocellular carcinoma (older than 18 years old and younger than 76 years old) -American society of anesthesia (ASA) class I-III -Patients who have agreed to the trial and signed the subject's consent
Exclusion Criteria	- Patients with who have history of side effects from the use of the anesthetic or have contraindication for drugs (a patient suspected of having an allergic reaction to the drug) - Patients who have liver cancer other than hepatocellular carcinoma (eg Cholangiocarcinoma or metastatic liver tumor) - Patients who is deemed inappropriate to participate in the clinical trial by the researcher's judgment - Patients who are allergic to nuts or beans - Patients who have a history of malignant hyperthermia or risk factors of malignant hyperthermia - Patients who underwent interventional procedure for HCC - Patients who have elevated intracranial hypertension - Patients who have distant metastasis to other organ - Patients who undergo ALPS (Associating liver partition and portal vein ligation for staged hepatectomy)
Healthy Volunteers

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Safety
Outcome	1 year recurrence free survival
Timepoint	1 year after the surgery
Secondary Outcome(s) 1
Outcome	1 year overall recurrence
Timepoint	1 year after the surgery
Secondary Outcome(s) 2
Outcome	1 year overall metastasis
Timepoint	1 year after the surgery
Secondary Outcome(s) 3
Outcome	1 year overall survival
Timepoint	1 year after the surgery
Secondary Outcome(s) 4
Outcome	3 year recurrence free survival
Timepoint	3 year after the surgery
Secondary Outcome(s) 5
Outcome	3 year overall survival
Timepoint	3 year after the surgery
Secondary Outcome(s) 6
Outcome	3 year recurrence
Timepoint	3 year after the surgery
Secondary Outcome(s) 7
Outcome	3 year metastasis
Timepoint	3 year after the surgery

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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