Hepatocellular Carcinoma
Conditions
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.
Detailed description
Before the scheduled procedure, the patients are randomly assigned into peopofol group or groups (1:1) according to the randomization generated by the computer. Both groups were induced with propofol 1\ 2.5 mg/kg propofol. The propofol group was maintained at an effect-site concentration of 2.0-4.0 mcg/mL by a target-controlled infusion system. The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC). During the operation, the dose of anesthetic drugs (propofol/fentanyl /remifentanil and sevoflurane/cisatracurium/rocuronium) are adjusted to maintain the mean arterial pressure and heartbeat fluctuations within 20% of the baseline value and Entropy (or BIS) value at 40-60in both groups. The following patient data were recorded, the type of anesthesia, sex, age at the time of surgery, preoperative Karnofsky performance status score and functional capacity, the postoperative complications within 30 days (according Clavien-Dindo classification), American Society of Anesthesiologists physical status scores, tumor size, intraoperative blood loss/transfusion, duration of surgery, duration of anesthesia, total opioid (remifentanil/fentanyl/ propofol) use, postoperative radiation therapy, postoperative chemotherapy, postoperative concurrent chemoradiotherapy, the presence of disease progression, and 6-month, 1-year, and 3-year overall survival and Karnofsky performance status score were recorded.
Interventions
DRUGPropofol
total intravenous anesthesia with propofol for the partial hepatectomy of hepatocellular carcinoma.
DRUGSevoflurane
The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC).
Sponsors
Tri-Service General Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Twenty to eighty-year-old. 2. ASA class I-III. 3. Patients undergoing partial hepatectomy for hepatocellular carcinoma under general anesthesia.
Exclusion criteria
1. Severe mental disorder 2. Pregnant or lactating women 3. Morbidly obese 4. Allergy to any of the drugs used in this study 5. Recurrent tumor or repeat surgery 6. Biopsy cases 7. Incomplete data collection before the surgery 8. Palliative treatment after surgery 9. simultaneous treatment of other malignancies 10. Combined propofol and inhalation anesthesia or other anesthetics, such as ketamine or dexmedetomidine 11. Diagnosed as benign liver tumor 12. Emergency surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 6-month overall survival, 1-year overall survival, and 3-year overall survival |
| The presence of disease progression | From the date of surgery until the date of first documented progression (recurrence or metastasis),assessed up to 36 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stays | from the day of surgery to dischage, assessed up to 30 days | the length of stays in general ward and ICU |
| 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 | to access patients' functional impairment |
| Postoperative complications | The period from the day of surgery to postoperative 30 days | Clavien-Dindo classification, and other postoperative complications |
Other
| Measure | Time frame | Description |
|---|---|---|
| time of operation and anesthesia | time of the total procedure | record the time the operation and anesthesia |
| blood loss and blood transfusion | during the operation of partial hepatectomy | record the blood loss (ml) and volume of blood transfusion (ml) |
Countries
Taiwan
Contacts
Primary ContactGuan-Yu Chen, M.D.
Outcome results
None listed