HCCNCT03104920
ERAS Program Improves Recovery of HCC Patient Undergoing Hepatectomy
A study testing ERAS Program and Traditional treatment in people with HCC, run by feng xiaobin at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HCC
- What is being tested?
- ERAS Program and Traditional treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- Viral infectious disease besides HBV and HCV;
- Diabetes Mellitus;
- Ruptured hepatocellular carcinoma;
- History of treatment such as TACE, RFI, PEI.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southwest Hospital
Chongqing, Chongqing Municipality, 400038
Xiaobin Feng
Kuansheng Ma, Ph.D
About this study
Official title: 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.
Read the 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.
- Conditions
- HCC
- Being tested
- ERAS Program, Traditional treatment
- Keywords
- ERAS, Time to ready for discharge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS ProgramProcedure or surgery
An ERAS pathway comprises of optimized management of diet, mobilization, multimodal perioperative analgesia and GI function recovery modalities.
Traditional treatmentProcedure or surgery
A traditional perioperative management for HCC.
| Study group | Role | What they receive |
|---|---|---|
| ERAS program | Experimental | We give an ERAS pathway, which comprises of optimized management of diet, mobilization, analgesia and GI function recovery for patients with HCC. Receives: Procedure: ERAS Program |
| Traditional treatment | Active comparator | We give routine clinic practices for the treatment of HCC. Receives: Procedure: Traditional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
TRD (time to ready for discharge)
time to ready for discharge
Measured: 1 month after surgery
Secondary outcomes (9)
Readmission within 30 days of discharge
Readmission within 30 days of discharge
Measured: 30 days after surgery
Complications rate
Complications rate
Measured: 3 months after surgery
Postoperative LOS (length of hospital stay)
Postoperative length of hospital stay
Measured: 30 days after surgery
Liver function recovery
Liver function recovery
Measured: 30 days after surgery
Surgery Stress （CRP）
Surgery Stress indicated by c-reactive protein
Measured: 15 days after surgery
Pain assessment（VAS，per day）
Pain assessment
Measured: 3 months after surgery
Total cost
Total cost
Measured: 3 months after surgery
Validated EQ-5D（EuroQol Group quantitum form）
Validated EQ-5D
Measured: 3 months after surgery
First time of normal diet and stool passage
First time of normal diet and stool passage
Measured: 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start27 Mar 2017
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 392 participants (estimated)
Sponsor and investigators
- Lead sponsor
- feng xiaobin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, feng xiaobin, Southwest Hospital, China
- Investigators
- Kuansheng Ma, Doctor, Study director, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104920
- Sponsor's protocol ID
- SWHB016
- Status last verified
- Mar 2017
- First submitted
- 27 Mar 2017
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERAS (Early Recovery After Surgery) Program Improve the Recovery of the Patient Undergoing Curative Hepatectomy: a Prospective Multicenter Cohort Trial
- ClinicalTrials.gov ID
- NCT03104920
- Acronym / sponsor ID
- SWHB016
- Conditions
- HCC
- Keywords
- ERAS, Time to ready for discharge
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 392 participants (estimated)
- Lead sponsor
- feng xiaobinUniversity, hospital or other
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 7 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS program | Experimental | Procedure: ERAS ProgramWe give an ERAS pathway, which comprises of optimized management of diet, mobilization, analgesia and GI function recovery for patients with HCC. |
| Traditional treatment | Active comparator | Procedure: Traditional treatmentWe give routine clinic practices for the treatment of HCC. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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；
Key exclusion criteria (10 listed)
- Tumor thrombi in portal vein;
- Tumor size >10cm;
- History of uncontrolled ascites, hepatic encephalopathy, and varices bleeding;
- ICG>14%;
- Concurrent with other malignant disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERAS ProgramAn ERAS pathway comprises of optimized management of diet, mobilization, multimodal perioperative analgesia and GI function recovery modalities. | Procedure or surgery | ERAS program |
| Traditional treatmentA traditional perioperative management for HCC. | Procedure or surgery | Traditional treatment |
Primary outcome
TRD (time to ready for discharge)
Time frame: 1 month after surgery
time to ready for discharge
9 secondary outcomes
Readmission within 30 days of discharge
Time frame: 30 days after surgery
Complications rate
Time frame: 3 months after surgery
Postoperative LOS (length of hospital stay)
Time frame: 30 days after surgery
Liver function recovery
Time frame: 30 days after surgery
Surgery Stress （CRP）
Time frame: 15 days after surgery
Pain assessment（VAS，per day）
Time frame: 3 months after surgery
Total cost
Time frame: 3 months after surgery
Validated EQ-5D（EuroQol Group quantitum form）
Time frame: 3 months after surgery
First time of normal diet and stool passage
Time frame: 7 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuansheng Ma, Doctor study director
Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS Program and Traditional treatment in people with HCC, run by feng xiaobin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaobin Feng, Doctor (86-23-68765297, fengxiaobin200708@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TRD (time to ready for discharge) (time frame: 1 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.