Clinical trial NCT02644603: Effect of Enhanced Recovery After Surgery(ERAS) After Liver Resection for Primary Liver Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carcinoma, Hepatocellular
Keywords: Enhanced Recovery After Surgery
hepatocellular carcinoma
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Eastern Hepatobiliary Surgery Hospital
name: RenJi Hospital
name: Anhui Provincial Hospital
name: Subei People's Hospital of Jiangsu Province
First posted: 2016-01-01
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment related complications
timeFrame: Up to 1 month since operation
Secondary outcomes:
measure: Length of stay in hospital
timeFrame: From the day a patient be hospitalized to the day discharged, up to 1 month.
measure: Total hospitalization costs
timeFrame: From the day a patient be hospitalized to the day discharged, up to 1 month.
measure: Preoperative and postoperative body weight
timeFrame: One day before operation, and the day patient discharged, up to 1 month.
measure: Hemoglobin (Hb) test Hb/ALB/PRE-A(g/L),
timeFrame: Day before operation and day 1/3/5 after operation.
measure: Albumin (ALB)
timeFrame: Day before operation and day 1/3/5 after operation.
measure: PRE-Albumin (PRE-A)
timeFrame: Day before operation and day 1/3/5 after operation.
measure: International Normalized Ratio (INR)
timeFrame: Day before operation and day 1/3/5 after operation.
measure: Platelet (PLT)
timeFrame: Day before operation and day 1/3/5 after operation.
measure: Blood Urea Nitrogen (BUN)
timeFrame: Day before operation and day 1/3/5 after operation.
measure: Blood Creatinine (sCr)
timeFrame: Day before operation and day 1/3/5 after operation.
measure: Alanine Transferase (ALT)
timeFrame: Day before operation and day 1/3/5 after operation.
measure: Aspartate Transaminase (AST)
timeFrame: Day before operation and day 1/3/5 after operation.
measure: Interleukin-6 (IL-6)
timeFrame: Day before operation and day 1/3/5 after operation.
measure: Interferon (IFN-γ)
timeFrame: Day before operation and day 1/3/5 after operation.
measure: Tumor necrosis factor-α (TNF-α)
timeFrame: Day before operation and day 1/3/5 after operation.
measure: Serum complement
timeFrame: Day before operation and day 1/3/5 after operation.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Jian Zhou, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Sun HC, Qin LX, Lu L, Wang L, Ye QH, Ren N, Fan J, Tang ZY. Randomized clinical trial of the effects of abdominal drainage after elective hepatectomy using the crushing clamp method. Br J Surg. 2006 Apr;93(4):422-6. doi: 10.1002/bjs.5260.
citation: Wilmore DW, Kehlet H. Management of patients in fast track surgery. BMJ. 2001 Feb 24;322(7284):473-6. doi: 10.1136/bmj.322.7284.473. No abstract available.
citation: Ni CY, Yang Y, Chang YQ, Cai H, Xu B, Yang F, Lau WY, Wang ZH, Zhou WP. Fast-track surgery improves postoperative recovery in patients undergoing partial hepatectomy for primary liver cancer: A prospective randomized controlled trial. Eur J Surg Oncol. 2013 Jun;39(6):542-7. doi: 10.1016/j.ejso.2013.03.013. Epub 2013 Apr 4.