Carcinoma, Hepatocellular
Conditions
Keywords
Enhanced Recovery After Surgery, hepatocellular carcinoma
Brief summary
The purpose of this study is to evaluate Enhanced Recovery After Surgery(ERAS) protocol versus conventional treatment on patients who underwent liver resection for hepatocellular carcinoma(HCC).
Detailed description
212 patients are randomly recruited from inpatients of Shanghai Zhongshan Hospital, Eastern Hepatobiliary Surgery Hospital, RenJi Hospital, Anhui Provincial Hospital, Subei People's Hospital of Jiangsu Province and Affiliated Tumor Hospital of Nantong University from February 2016 to July 2016. Randomly assigned about half of the patients to receive Enhanced Recovery After Surgery(ERAS) protocol and the other half to receive conventional treatment. Evaluate the safety and efficacy of the ERAS protocol.
Interventions
PROCEDUREEnhanced Recovery After Surgery
Before operation: Preoperative optimization of organ function, No preoperative bowel preparation, Prohibit eating 6h, drinking water 2h before operation, Oral rehydration before operation. In operation: Optimized combined anesthesia, Minimal invasive operations, Normothermia, Minimal use of tubes and drains. After operation: Postoperative analgesia and antiemetic, Early mobilization, Oral nutrition, Early and scheduled mobilization.
Sponsors
Eastern Hepatobiliary Surgery Hospital
RenJi Hospital
Anhui Provincial Hospital
Subei People's Hospital of Jiangsu Province
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with HCC with indications for surgery * Without any surgical contraindications * Under went open liver resection * Operation ranges less than 4 hepatic segments * Informed consent
Exclusion criteria
* Not suitable for surgery * Benign lesions or other lesions proved by pathology * Surgical procedure changed during operation or combined evisceration * Refused to participate or drop out
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment related complications | Up to 1 month since operation | Number of adverse events that are related to treatment of each patients, and hospital readmission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total hospitalization costs | From the day a patient be hospitalized to the day discharged, up to 1 month. | Total hospitalization costs (RMB yuan). |
| Preoperative and postoperative body weight | One day before operation, and the day patient discharged, up to 1 month. | Patient's body weight in kg. |
| Hemoglobin (Hb) test Hb/ALB/PRE-A(g/L), | Day before operation and day 1/3/5 after operation. | Hb in g/L. |
| Albumin (ALB) | Day before operation and day 1/3/5 after operation. | ALB in g/L. |
| PRE-Albumin (PRE-A) | Day before operation and day 1/3/5 after operation. | PRE-A in g/L |
| International Normalized Ratio (INR) | Day before operation and day 1/3/5 after operation. | INR in seconds. |
| Platelet (PLT) | Day before operation and day 1/3/5 after operation. | PLT in 10\^9/L |
| Length of stay in hospital | From the day a patient be hospitalized to the day discharged, up to 1 month. | Length of stay in hospital (days) |
| Blood Creatinine (sCr) | Day before operation and day 1/3/5 after operation. | sCr in umol/L |
| Alanine Transferase (ALT) | Day before operation and day 1/3/5 after operation. | ALT in U/L |
| Aspartate Transaminase (AST) | Day before operation and day 1/3/5 after operation. | AST in U/L |
| Interleukin-6 (IL-6) | Day before operation and day 1/3/5 after operation. | IL-6 in (pg/ml) |
| Interferon (IFN-γ) | Day before operation and day 1/3/5 after operation. | IFN-γin pg/ml. |
| Tumor necrosis factor-α (TNF-α) | Day before operation and day 1/3/5 after operation. | TNF-αin pg/ml |
| Serum complement | Day before operation and day 1/3/5 after operation. | C3 and C4 in mg/dl |
| Blood Urea Nitrogen (BUN) | Day before operation and day 1/3/5 after operation. | BUN in mmol/L |
Countries
China
Outcome results
None listed