Clinical Trial: Effect of Enhanced Recovery After Surgery(ERAS) After Liver Resection for Primary Liver Cancer

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Safety and Efficacy of the Enhanced Recovery After Surgery(ERAS) After Liver Resection for Primary Liver Cancer: a Multicenter, Randomized, Controlled Clinical Study

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 Summary: 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.
Sponsor: Shanghai Zhongshan Hospital

Current Primary Outcome: Treatment related complications [ Time Frame: Up to 1 month since operation ]

Number of adverse events that are related to treatment of each patients, and hospital readmission


Original Primary Outcome: Treatment related complications [ Time Frame: Up to 3 months since operation ]

Number of adverse events that are related to treatment of each patients


Current Secondary Outcome:

  • Length of stay in hospital [ Time Frame: From the day a patient be hospitalized to the day discharged, up to 1 month. ]
    Length of stay in hospital (days)
  • Total hospitalization costs [ Time Frame: 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 [ Time Frame: 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), [ Time Frame: Day before operation and day 1/3/5 after operation. ]
    Hb in g/L.
  • Albumin (ALB) [ Time Frame: Day before operation and day 1/3/5 after operation. ]
    ALB in g/L.
  • PRE-Albumin (PRE-A) [ Time Frame: Day before operation and day 1/3/5 after operation. ]
    PRE-A in g/L
  • International Normalized Ratio (INR) [ Time Frame: Day before operation and day 1/3/5 after operation. ]
    INR in seconds.
  • Platelet (PLT) [ Time Frame: Day before operation and day 1/3/5 after operation. ]
    PLT in 10^9/L
  • Blood Urea Nitrogen (BUN) [ Time Frame: Day before operation and day 1/3/5 after operation. ]
    BUN in mmol/L
  • Blood Creatinine (sCr) [ Time Frame: Day before operation and day 1/3/5 after operation. ]
    sCr in umol/L
  • Alanine Transferase (ALT) [ Time Frame: Day before operation and day 1/3/5 after operation. ]
    ALT in U/L
  • Aspartate Transaminase (AST) [ Time Frame: Day before operation and day 1/3/5 after operation. ]
    AST in U/L
  • Interleukin-6 (IL-6) [ Time Frame: Day before operation and day 1/3/5 after operation. ]
    IL-6 in (pg/ml)
  • Interferon (IFN-γ) [ Time Frame: Day before operation and day 1/3/5 after operation. ]
    IFN-γin pg/ml.
  • Tumor necrosis factor-α (TNF-α) [ Time Frame: Day before operation and day 1/3/5 after operation. ]
    TNF-αin pg/ml
  • Serum complement [ Time Frame: Day before operation and day 1/3/5 after operation. ]
    C3 and C4 in mg/dl


Original Secondary Outcome:

  • Length of stay in hospital [ Time Frame: From the day a patient be hospitalized to the day discharged, up to 1 year. ]
    Length of stay in hospital (days)
  • Total hospitalization costs [ Time Frame: From the day a patient be hospitalized to the day discharged, up to 1 year. ]
    Total hospitalization costs (RMB yuan).
  • Fever [ Time Frame: From the day a patient underwent operation to the day discharged, up to 1 year. ]
    Times a patient's body temperature went higher than 38℃.
  • Nausea and Vomiting [ Time Frame: From the day a patient underwent operation to the day discharged, up to 1 year. ]
    Times a patient nausea and vomiting after operation.
  • Wound infection [ Time Frame: From the day a patient underwent operation to the day discharged, up to 1 year. ]
    Wether a patients's wound get infected (Yes or No)
  • Ascites [ Time Frame: Day1/3/5 after operation. ]
    Volume of each patient's ascites (ml).
  • Hospital associated pneumonia [ Time Frame: From the day a patient underwent operation to the discharged, up to 1 year. ]
    Wether a patients's wound get hospital associated pneumonia(Yes or No).
  • Preoperative and postoperative body weight [ Time Frame: One day before operation, and the day patient discharged, up to 1 year. ]
    Patient's body weight in kg.
  • Hemoglobin (Hb) test Hb/ALB/PRE-A(g/L), [ Time Frame: Day before operation and day 1/3/5 after operation. ]
    Hb in g/L.
  • Albumin (ALB) [ Time Frame: Day before operation and day 1/3/5 after operation. ]
    ALB in g/L.
  • PRE-Albumin (PRE-A) [ Time Frame: Day before operation and day 1/3/5 after operation. ]
    PRE-A in g/L
  • International Normalized Ratio (INR) [ Time Frame: Day before operation and day 1/3/5 after operation. ]
    INR in seconds.
  • Platelet (PLT) [ Time Frame: Day before operation and day 1/3/5 after operation. ]
    PLT in 10^9/L
  • Blood Urea Nitrogen (BUN) [ Time Frame: Day before operation and day 1/3/5 after operation. ]
    BUN in mmol/L
  • Blood Creatinine (sCr) [ Time Frame: Day before operation and day 1/3/5 after operation. ]
    sCr in umol/L
  • Alanine Transferase (ALT) [ Time Frame: Day before operation and day 1/3/5 after operation. ]
    ALT in U/L
  • Aspartate Transaminase (AST) [ Time Frame: Day before operation and day 1/3/5 after operation. ]
    AST in U/L
  • Interleukin-6 (IL-6) [ Time Frame: Day before operation and day 1/3/5 after operation. ]
    IL-6 in (pg/ml)
  • Interferon (IFN-γ) [ Time Frame: Day before operation and day 1/3/5 after operation. ]
    IFN-γin pg/ml.
  • Tumor necrosis factor-α (TNF-α) [ Time Frame: Day before operation and day 1/3/5 after operation. ]
    TNF-αin pg/ml
  • Serum complement [ Time Frame: Day before operation and day 1/3/5 after operation. ]
    C3 and C4 in mg/dl
  • Long term follow-up [ Time Frame: 5 years ]
    Readmission rates, disease-free survival period, overall survival period


Information By: Shanghai Zhongshan Hospital

Dates:
Date Received: December 15, 2015
Date Started: February 2016
Date Completion: March 2017
Last Updated: March 21, 2017
Last Verified: February 2017