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

Primary Purpose

Carcinoma, Hepatocellular

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Enhanced Recovery After Surgery
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Enhanced Recovery After Surgery, hepatocellular carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhongshan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Enhanced Recovery After Surgery

Conventional Treatment

Arm Description

Patients underwent ERAS protocol

Patients underwent conventional treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Length of stay in hospital
Length of stay in hospital (days)
Total hospitalization costs
Total hospitalization costs (RMB yuan).
Preoperative and postoperative body weight
Patient's body weight in kg.
Hemoglobin (Hb) test Hb/ALB/PRE-A(g/L),
Hb in g/L.
Albumin (ALB)
ALB in g/L.
PRE-Albumin (PRE-A)
PRE-A in g/L
International Normalized Ratio (INR)
INR in seconds.
Platelet (PLT)
PLT in 10^9/L
Blood Urea Nitrogen (BUN)
BUN in mmol/L
Blood Creatinine (sCr)
sCr in umol/L
Alanine Transferase (ALT)
ALT in U/L
Aspartate Transaminase (AST)
AST in U/L
Interleukin-6 (IL-6)
IL-6 in (pg/ml)
Interferon (IFN-γ)
IFN-γin pg/ml.
Tumor necrosis factor-α (TNF-α)
TNF-αin pg/ml
Serum complement
C3 and C4 in mg/dl

Full Information

First Posted
December 15, 2015
Last Updated
June 24, 2017
Sponsor
Shanghai Zhongshan Hospital
Collaborators
Eastern Hepatobiliary Surgery Hospital, RenJi Hospital, Anhui Provincial Hospital, Subei People's Hospital of Jiangsu Province
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1. Study Identification

Unique Protocol Identification Number
NCT02644603
Brief Title
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

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital
Collaborators
Eastern Hepatobiliary Surgery Hospital, RenJi Hospital, Anhui Provincial Hospital, Subei People's Hospital of Jiangsu Province

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
Keywords
Enhanced Recovery After Surgery, hepatocellular carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Recovery After Surgery
Arm Type
Experimental
Arm Description
Patients underwent ERAS protocol
Arm Title
Conventional Treatment
Arm Type
No Intervention
Arm Description
Patients underwent conventional treatment
Intervention Type
Procedure
Intervention Name(s)
Enhanced Recovery After Surgery
Other Intervention Name(s)
Fast Track Surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment related complications
Description
Number of adverse events that are related to treatment of each patients, and hospital readmission
Time Frame
Up to 1 month since operation
Secondary Outcome Measure Information:
Title
Length of stay in hospital
Description
Length of stay in hospital (days)
Time Frame
From the day a patient be hospitalized to the day discharged, up to 1 month.
Title
Total hospitalization costs
Description
Total hospitalization costs (RMB yuan).
Time Frame
From the day a patient be hospitalized to the day discharged, up to 1 month.
Title
Preoperative and postoperative body weight
Description
Patient's body weight in kg.
Time Frame
One day before operation, and the day patient discharged, up to 1 month.
Title
Hemoglobin (Hb) test Hb/ALB/PRE-A(g/L),
Description
Hb in g/L.
Time Frame
Day before operation and day 1/3/5 after operation.
Title
Albumin (ALB)
Description
ALB in g/L.
Time Frame
Day before operation and day 1/3/5 after operation.
Title
PRE-Albumin (PRE-A)
Description
PRE-A in g/L
Time Frame
Day before operation and day 1/3/5 after operation.
Title
International Normalized Ratio (INR)
Description
INR in seconds.
Time Frame
Day before operation and day 1/3/5 after operation.
Title
Platelet (PLT)
Description
PLT in 10^9/L
Time Frame
Day before operation and day 1/3/5 after operation.
Title
Blood Urea Nitrogen (BUN)
Description
BUN in mmol/L
Time Frame
Day before operation and day 1/3/5 after operation.
Title
Blood Creatinine (sCr)
Description
sCr in umol/L
Time Frame
Day before operation and day 1/3/5 after operation.
Title
Alanine Transferase (ALT)
Description
ALT in U/L
Time Frame
Day before operation and day 1/3/5 after operation.
Title
Aspartate Transaminase (AST)
Description
AST in U/L
Time Frame
Day before operation and day 1/3/5 after operation.
Title
Interleukin-6 (IL-6)
Description
IL-6 in (pg/ml)
Time Frame
Day before operation and day 1/3/5 after operation.
Title
Interferon (IFN-γ)
Description
IFN-γin pg/ml.
Time Frame
Day before operation and day 1/3/5 after operation.
Title
Tumor necrosis factor-α (TNF-α)
Description
TNF-αin pg/ml
Time Frame
Day before operation and day 1/3/5 after operation.
Title
Serum complement
Description
C3 and C4 in mg/dl
Time Frame
Day before operation and day 1/3/5 after operation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Zhou, MD, PhD
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
16491462
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.
Results Reference
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PubMed Identifier
11222424
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.
Results Reference
background
PubMed Identifier
23562361
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.
Results Reference
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Effect of Enhanced Recovery After Surgery(ERAS) After Liver Resection for Primary Liver Cancer

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