Carcinoma, HepatocellularNCT02644603
Effect of Enhanced Recovery After Surgery(ERAS) After Liver Resection for Primary Liver Cancer
A study testing Enhanced Recovery After Surgery in people with Carcinoma, Hepatocellular, run by Shanghai Zhongshan Hospital at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Enhanced Recovery After Surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to Jun 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Enhanced Recovery After Surgery
- Keywords
- Enhanced Recovery After Surgery, hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery After SurgeryProcedure or surgery
Also called Fast Track 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.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Recovery After Surgery | Experimental | Patients underwent ERAS protocol Receives: Procedure: Enhanced Recovery After Surgery |
| Conventional Treatment | No intervention | Patients underwent conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment related complications
Number of adverse events that are related to treatment of each patients, and hospital readmission
Measured: Up to 1 month since operation
Secondary outcomes (16)
Length of stay in hospital
Length of stay in hospital (days)
Measured: From the day a patient be hospitalized to the day discharged, up to 1 month.
Total hospitalization costs
Total hospitalization costs (RMB yuan).
Measured: From the day a patient be hospitalized to the day discharged, up to 1 month.
Preoperative and postoperative body weight
Patient's body weight in kg.
Measured: One day before operation, and the day patient discharged, up to 1 month.
Hemoglobin (Hb) test Hb/ALB/PRE-A(g/L),
Hb in g/L.
Measured: Day before operation and day 1/3/5 after operation.
Albumin (ALB)
ALB in g/L.
Measured: Day before operation and day 1/3/5 after operation.
PRE-Albumin (PRE-A)
PRE-A in g/L
Measured: Day before operation and day 1/3/5 after operation.
International Normalized Ratio (INR)
INR in seconds.
Measured: Day before operation and day 1/3/5 after operation.
Platelet (PLT)
PLT in 10^9/L
Measured: Day before operation and day 1/3/5 after operation.
Blood Urea Nitrogen (BUN)
BUN in mmol/L
Measured: Day before operation and day 1/3/5 after operation.
Blood Creatinine (sCr)
sCr in umol/L
Measured: Day before operation and day 1/3/5 after operation.
Alanine Transferase (ALT)
ALT in U/L
Measured: Day before operation and day 1/3/5 after operation.
Aspartate Transaminase (AST)
AST in U/L
Measured: Day before operation and day 1/3/5 after operation.
Interleukin-6 (IL-6)
IL-6 in (pg/ml)
Measured: Day before operation and day 1/3/5 after operation.
Interferon (IFN-γ)
IFN-γin pg/ml.
Measured: Day before operation and day 1/3/5 after operation.
Tumor necrosis factor-α (TNF-α)
TNF-αin pg/ml
Measured: Day before operation and day 1/3/5 after operation.
Serum complement
C3 and C4 in mg/dl
Measured: Day before operation and day 1/3/5 after operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2016
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eastern Hepatobiliary Surgery Hospital, RenJi Hospital, Anhui Provincial Hospital, Subei People's Hospital of Jiangsu Province
- Responsible party
- Sponsor
- Investigators
- Jian Zhou, MD, PhD, Study director, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644603
- Sponsor's protocol ID
- H-ERAS-MRCT-1511
- Status last verified
- Jun 2017
- First submitted
- 15 Dec 2015
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 16491462Wilmore 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.
PubMed 11222424Ni 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.
PubMed 23562361
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02644603
- Acronym / sponsor ID
- H-ERAS-MRCT-1511
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Enhanced Recovery After Surgery, hepatocellular carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Eastern Hepatobiliary Surgery Hospital, RenJi Hospital, Anhui Provincial Hospital, Subei People's Hospital of Jiangsu Province
- Study start
- Feb 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2017 (estimated)
- First posted
- 1 Jan 2016 (estimated)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Recovery After Surgery | Experimental | Procedure: Enhanced Recovery After SurgeryPatients underwent ERAS protocol |
| Conventional Treatment | No intervention | –Patients underwent conventional treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Enhanced Recovery After SurgeryAlso: Fast Track SurgeryBefore 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. | Procedure or surgery | Enhanced Recovery After Surgery |
Primary outcome
Treatment related complications
Time frame: Up to 1 month since operation
Number of adverse events that are related to treatment of each patients, and hospital readmission
16 secondary outcomes
Length of stay in hospital
Time frame: From the day a patient be hospitalized to the day discharged, up to 1 month.
Total hospitalization costs
Time frame: From the day a patient be hospitalized to the day discharged, up to 1 month.
Preoperative and postoperative body weight
Time frame: One day before operation, and the day patient discharged, up to 1 month.
Hemoglobin (Hb) test Hb/ALB/PRE-A(g/L),
Time frame: Day before operation and day 1/3/5 after operation.
Albumin (ALB)
Time frame: Day before operation and day 1/3/5 after operation.
PRE-Albumin (PRE-A)
Time frame: Day before operation and day 1/3/5 after operation.
International Normalized Ratio (INR)
Time frame: Day before operation and day 1/3/5 after operation.
Platelet (PLT)
Time frame: Day before operation and day 1/3/5 after operation.
Blood Urea Nitrogen (BUN)
Time frame: Day before operation and day 1/3/5 after operation.
Blood Creatinine (sCr)
Time frame: Day before operation and day 1/3/5 after operation.
Alanine Transferase (ALT)
Time frame: Day before operation and day 1/3/5 after operation.
Aspartate Transaminase (AST)
Time frame: Day before operation and day 1/3/5 after operation.
Interleukin-6 (IL-6)
Time frame: Day before operation and day 1/3/5 after operation.
Interferon (IFN-γ)
Time frame: Day before operation and day 1/3/5 after operation.
Tumor necrosis factor-α (TNF-α)
Time frame: Day before operation and day 1/3/5 after operation.
Serum complement
Time frame: Day before operation and day 1/3/5 after operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- Background: PubMed 16491462Sun 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.
- Background: PubMed 11222424Wilmore 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.
- Background: PubMed 23562361Ni 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.
- Individual participant dataSharing planned: Undecided
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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.
Jian Zhou, MD, PhD study director
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Recovery After Surgery in people with Carcinoma, Hepatocellular, run by Shanghai Zhongshan Hospital 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 5 inclusion and 4 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 27 Jun 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment related complications (time frame: Up to 1 month since operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02644603, which also lists 3 linked publications.
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 27 Jun 2017.