ERAS Program Improves Recovery of HCC Patient Undergoing Hepatectomy

ERAS (Early Recovery After Surgery) Program Improve the Recovery of the Patient Undergoing Curative Hepatectomy: a Prospective Multicenter Cohort Trial

The worldwide introduction of multimodal enhanced recovery programs has also changed perioperative care in patients who undergo liver resection. This study will be performed to assess a comprehensive care package for patients with hepatocellular carcinoma (HCC) undergoing hepatectomy with the aim of minimal physiological disturbance in the peri-operative period. Peri-operative opioid-sparing analgesia with few gastrointestinal (GI) effects and reduced requirement for intravenous fluid therapy, early ambulation and promoted GI function recovery were centered to this plan.

Study Overview

• Status: Unknown
• Conditions: HCC
• Intervention / Treatment: Procedure: ERAS Program; Procedure: Traditional treatment

Detailed Description

The first ERAS program was introduced by Kehlet in the 1990's. ERAS programs were initially implemented in colorectal surgery and have found their way into general clinical practice, including orthopedic, vascular, and thoracic surgery. In the field of liver surgery, cohort studies have been conducted and randomized trials have confirmed the feasibility and safety of enhanced recovery programs in resectional liver surgery.

Randomized studies have suggested that ERAS optimization may contribute in decreasing stay in hospital after surgery. We hypothesized that opioid-sparing preemptive and post-operative multimodal analgesia plus other ERAS items would effectively accelerate patient recovery, who receiving hepatectomy. We focus on some fundamental variables that impact normal physiology and enhanced-recovery after surgery: fasting, opioid-sparing, exception of an abdominal drain, and GI function rehabilitation. We draw attention to the fact that time to recovery is a far more important and better outcome measure than time to discharge from the hospital.

GI function protection and restore was of importance as the respect of ERAS. Traditionally, perioperative fasting is consisted of being nil by mouth from midnight before surgery and fasting postoperatively until recovery of bowel function. Those empirical practices persist despite emerging evidence revealing that excessive fasting results in negative outcomes and delayed recovery. Strong and assistant evidence exists for minimization of perioperative fasting for 2-hour preoperative fast after clear fluids and for early oral food and fluids intake postoperatively. Also, current study should be applying anti-ileus prophylaxis and abolition of bowel preparation.

Optimizing pain control was regarding as one of the ultimate goal of ERAS program: pain and risk free surgery. Surgical incisions evoke nociceptors by inducing local inflammatory response. The consequence hyperalgesia has been considered to be target of well pain controlling. Here, the multimodal opioid-sparing approaches have been emphasized. A regimen composed by TAP, local anesthesia, PCA, and systematic anti-inflammatory would be performed in order to reduce surgical stress responses.

Several studies have reported that mobilization within 24h of colon surgery was an independent predictor of shorter rehabilitation period. In current study, early postoperative enforced mobilization with specific target will be implemented.

The purpose of this study is twofold. On the one hand examine the scientific evidence that exists today on the most important elements of an ERAS program and present preliminary results of the implementation of a program ERAS in West China.

• Study Type: Interventional
• Enrollment (Anticipated): 392
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • Recruiting
      • Southwest Hospital
      • Contact: Xiaobin Feng
      • Principal Investigator: Kuansheng Ma, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Informed consent;
• Elective partial hepatectomy for HCC;
• No major concomitant surgical procedures such as bowl or bile duct resection;
• Tumors restricted in hepatic segment: II, III, IVb, VI and VII;
• Child-Pugh Class A/B liver function status；
• ECGO scores = 0

Exclusion Criteria:

• Tumor thrombi in portal vein;
• Tumor size >10cm;
• History of uncontrolled ascites, hepatic encephalopathy, and varices bleeding;
• ICG>14%;
• Concurrent with other malignant disease;
• Multiple organ dysfunctions;
• Viral infectious disease besides HBV and HCV;
• Diabetes Mellitus;
• Ruptured hepatocellular carcinoma;
• History of treatment such as TACE, RFI, PEI.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ERAS program; We give an ERAS pathway, which comprises of optimized management of diet, mobilization, analgesia and GI function recovery for patients with HCC.	Procedure: ERAS Program; An ERAS pathway comprises of optimized management of diet, mobilization, multimodal perioperative analgesia and GI function recovery modalities.
Active Comparator: Traditional treatment; We give routine clinic practices for the treatment of HCC.	Procedure: Traditional treatment; A traditional perioperative management for HCC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TRD (time to ready for discharge)	time to ready for discharge	1 month after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmission within 30 days of discharge	Readmission within 30 days of discharge	30 days after surgery
Complications rate	Complications rate	3 months after surgery
Postoperative LOS (length of hospital stay)	Postoperative length of hospital stay	30 days after surgery
Liver function recovery	Liver function recovery	30 days after surgery
Surgery Stress （CRP）	Surgery Stress indicated by c-reactive protein	15 days after surgery
Pain assessment（VAS，per day）	Pain assessment	3 months after surgery
Total cost	Total cost	3 months after surgery
Validated EQ-5D（EuroQol Group quantitum form）	Validated EQ-5D	3 months after surgery
First time of normal diet and stool passage	First time of normal diet and stool passage	7 days after surgery

Collaborators and Investigators

• Sponsor: feng xiaobin
• Investigators: Study Director: Kuansheng Ma, Doctor, Third Military Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2017
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: April 1, 2017
• First Posted (Actual): April 7, 2017

Study Record Updates

• Last Update Posted (Actual): April 7, 2017
• Last Update Submitted That Met QC Criteria: April 1, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: ERAS; Time to ready for discharge
• Other Study ID Numbers: SWHB016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No