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

Carcinoma, Hepatocellular Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02644603
• Other study ID #: H-ERAS-MRCT-1511
• Status: Active, not recruiting
• Phase: N/A
• First received: December 15, 2015
• Last updated: June 24, 2017
• Start date: February 2016
• Est. completion date: June 2017

Study information

• Verified date: June 2017
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 214
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Anhui Provincial Hospital, Eastern Hepatobiliary Surgery Hospital, RenJi Hospital, Subei People's Hospital of Jiangsu Province

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View Citation

Wilmore DW, Kehlet H. Management of patients in fast track surgery. BMJ. 2001 Feb 24;322(7284):473-6. Review. — View Citation

Outcome

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