NCT05331911

Brief Summary

This is a two-arm, parallel-group randomized clinical trial. Routine perioperative care would be performed in volunteers with primary Hepatocellular carcinoma. The study will enroll approximately 500 volunteers to compare the progression-free or overall survival in patients undergoing elective partial hepatectomy for primary liver tumors between propofol and sevoflurane for the maintenance of anesthesia.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for phase_4 hepatocellular-carcinoma

Timeline
10mo left

Started Apr 2022

Longer than P75 for phase_4 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Apr 2022Mar 2027

First Submitted

Initial submission to the registry

March 29, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

April 26, 2022

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

November 30, 2022

Status Verified

March 1, 2022

Enrollment Period

4.7 years

First QC Date

March 29, 2022

Last Update Submit

November 28, 2022

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Overall survival

    6-month overall survival, 1-year overall survival, and 3-year overall survival

    From the date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months"

  • The presence of disease progression

    From the date of surgery until the date of first documented progression (recurrence or metastasis) or date of death from any cause, assessed up to 36 months"

    From the date of surgery until the date of first documented progression (recurrence or metastasis),assessed up to 36 months

Secondary Outcomes (3)

  • Postoperative complications

    The period from the day of surgery to postoperative 30 days

  • Karnofsky performance status score

    Karnofsky performance score(from 0 (dead) to 100(normal no complication)) before surgery (baseline data) , postoperation 7 days, postoperation 3 months, postoperation 6 months, postoperation 12 months

  • Length of hospital stays

    from the day of surgery to dischage, assessed up to 30 days

Other Outcomes (2)

  • time of operation and anesthesia

    time of the total procedure

  • blood loss and blood transfusion

    during the operation of partial hepatectomy

Study Arms (2)

Propofol Group

EXPERIMENTAL

The propofol group was maintained at an effect-site concentration (Ce) of 2.0-4.0 mcg/mL by a target-controlled infusion (TCI) system.

Drug: Propofol

Sevoflurane group

EXPERIMENTAL

The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC).

Drug: Sevoflurane

Interventions

PropofolDRUG

total intravenous anesthesia with propofol for the partial hepatectomy of hepatocellular carcinoma.

Also known as: total intravenous anesthesia
Propofol Group
SevofluraneDRUG

The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC).

Sevoflurane group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Twenty to eighty-year-old.
  • ASA class I-III.
  • Patients undergoing partial hepatectomy for hepatocellular carcinoma under general anesthesia.

You may not qualify if:

  • Severe mental disorder
  • Pregnant or lactating women
  • Morbidly obese
  • Allergy to any of the drugs used in this study
  • Recurrent tumor or repeat surgery
  • Biopsy cases
  • Incomplete data collection before the surgery
  • Palliative treatment after surgery
  • simultaneous treatment of other malignancies
  • Combined propofol and inhalation anesthesia or other anesthetics, such as ketamine or dexmedetomidine
  • Diagnosed as benign liver tumor
  • Emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

PropofolSevoflurane

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Central Study Contacts

Guan-Yu Chen, M.D.

CONTACT

07-3121101kindtaco@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2022

First Posted

April 18, 2022

Study Start

April 26, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

November 30, 2022

Record last verified: 2022-03

Locations

TW(1)