Clinical trial NCT03104920: ERAS Program Improves Recovery of HCC Patient Undergoing Hepatectomy
Official title: ERAS (Early Recovery After Surgery) Program Improve the Recovery of the Patient Undergoing Curative Hepatectomy: a Prospective Multicenter Cohort Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HCC
Keywords: ERAS
Time to ready for discharge
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: TRD (time to ready for discharge)
timeFrame: 1 month after surgery
Secondary outcomes:
measure: Readmission within 30 days of discharge
timeFrame: 30 days after surgery
measure: Complications rate
timeFrame: 3 months after surgery
measure: Postoperative LOS (length of hospital stay)
timeFrame: 30 days after surgery
measure: Liver function recovery
timeFrame: 30 days after surgery
measure: Surgery Stress （CRP）
timeFrame: 15 days after surgery
measure: Pain assessment（VAS，per day）
timeFrame: 3 months after surgery
measure: Total cost
timeFrame: 3 months after surgery
measure: Validated EQ-5D（EuroQol Group quantitum form）
timeFrame: 3 months after surgery
measure: First time of normal diet and stool passage
timeFrame: 7 days after surgery
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
Study officials:
affiliation: Third Military Medical University
name: Kuansheng Ma, Doctor
role: STUDY_DIRECTOR
References: