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

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

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).

Study Overview

• Status: Unknown
• Conditions: Carcinoma, Hepatocellular
• Intervention / Treatment: Procedure: Enhanced Recovery After Surgery

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.

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced Recovery After Surgery; Patients underwent ERAS protocol	Procedure: Enhanced 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.; Other Names: Fast Track Surgery
No Intervention: Conventional Treatment; Patients underwent conventional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment related complications	Number of adverse events that are related to treatment of each patients, and hospital readmission	Up to 1 month since operation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Collaborators: RenJi Hospital; Eastern Hepatobiliary Surgery Hospital; Anhui Provincial Hospital; Subei People's Hospital of Jiangsu Province
• Investigators: Study Director: Jian Zhou, MD, PhD, Shanghai Zhongshan Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: December 15, 2015
• First Submitted That Met QC Criteria: December 30, 2015
• First Posted (Estimate): January 1, 2016

Study Record Updates

• Last Update Posted (Actual): June 27, 2017
• Last Update Submitted That Met QC Criteria: June 24, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: hepatocellular carcinoma; Enhanced Recovery After Surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Carcinoma, Hepatocellular; Liver Neoplasms
• Other Study ID Numbers: H-ERAS-MRCT-1511

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED