Liver CancerNCT03223818
The Impact of Fast-track Perioperative Program After Liver Resection in Hong Kong Chinese Patients
A study testing Fast-track peri-operative program in people with Liver Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Liver cancer was the third leading cause of cancer death in both sexes in Hong Kong and liver resection remains the mainstay of curative treatment. Post-operative recovery from liver resection has historically been fraught with a high incidence of complications, ranging from 15-48%, and the high incidence of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Fast-track peri-operative program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2018to 1 Jul 2025
- 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
- All consecutive patients undergoing elective liver resection (open and laparoscopic).
- Age of patients between 18 and 70 years.
- Patients with American Society of Anaesthesiologists (ASA) grading I-II.
- Patients with no severe physical disability.
- Patients who require no assistance on the activities of daily living.
- Informed consent available will be recruited.
Who cannot join
- Patients undergoing emergency surgery.
- Patients who had received pre-operative portal vein embolization.
- Patients who are expected to receive concomitant procedures other than cholecystectomy.
- Pregnant ladies and patients who are mentally incapable of written consent will be excluded.
- Patient who had previous history of Hepato-biliary and pancreatic surgery.
- Patient who had chronic pain syndrome.
Trial locations and contacts
1 site in 1 country.
CREC contact
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Surgery
Hong Kong
Charing CHONG, MBChB, 852 2632 1411, chongcn@surgery.cuhk.edu.hk
About this study
Official title: The Impact of Fast-track Perioperative Program on the Clinical and Immunological Outcomes After Liver Resection in Hong Kong Chinese Patients: A Prospective Randomized Trial
Liver cancer was the third leading cause of cancer death in both sexes in Hong Kong and liver resection remains the mainstay of curative treatment. Post-operative recovery from liver resection has historically been fraught with a high incidence of complications, ranging from 15-48%, and the high incidence of complications leads to prolonged hospital stay, ranging from 9 - 15 days, and increase costs of hospitalization. Recent advancement in the perioperative surgical and anesthetic management of patients undergoing liver resection has led to improvement in these outcomes.
The investigators department had previously studied the impact and confirmed the benefit of fast-track peri-operative programs after laparoscopic colorectal surgery. Nevertheless, studies regarding its adoption in liver resection are limited. The investigators group had previously reported, in a retrospective cohort, that successful implementation of ERAS protocol was associated with a significantly shorten hospital stay. However, the peri-operative management in that study incorporated a small proportion of components described in ERAS programs for liver resection and there was no direct comparison with conventional peri-operative program.
The aim of this study is to compare the clinical and immunological outcomes of Hong Kong Chinese patients undergoing liver resection for liver cancer with a "conventional" vs a "fast-track" perioperative program.
Read the detailed description
Liver cancer was the third leading cause of cancer death in both sexes in Hong Kong and liver resection remains the mainstay of curative treatment. Post-operative recovery from liver resection has historically been fraught with a high incidence of complications, ranging from 15-48%, and the high incidence of complications leads to prolonged hospital stay, ranging from 9 - 15 days, and increase costs of hospitalization. Recent advancement in the perioperative surgical and anesthetic management of patients undergoing liver resection has led to improvement in these outcomes.
Since its formal introduction in 1990s, fast-track or enhanced recovery after surgery (ERAS) peri-operative programs have gained territory quickly because of the associated cost efficiency derived from the reduction in hospital stay, an important issue in today's context of rapidly increasing health care costs and the consequent need for optimization. The benefits of fast-track peri-operative programs have been well proven in colectomy. Our department had previously demonstrated the feasibility and impact of fast-track peri-operative programs after laparoscopic colorectal surgery, which leads to the potential for application to other subspecialties. Nevertheless, studies evaluating fast-track peri-operative programs in liver resection are scarce. Most of them were carried out in Western countries and almost all of them used epidural analgesia for post-operative pain control. While most of the livers in Western patients are non-cirrhotic, the main challenge of liver resection in Chinese Hong Kong patients is the background liver cirrhosis as hepatitis-related hepatocellular carcinoma is the most common indication for liver resection. Although epidural analgesia has been showed to be effective after liver resection without complication, the debate on epidural analgesia continues. Coagulopathy, thrombocytopenia and other haematological abnormalities may impose additional risks of epidural hematoma formation following removal of the epidural catheter postoperatively. Especially there is a much greater incidence of co-existing liver cirrhosis in Chinese Hong Kong patients with hepatocelluar carcinoma. This group of patients is coagulopathic even before liver resection and the risk of bleeding complications related to epidural analgesia is a particular concern. Continuous wound instillation with local anesthetic agent by the ON-Q PainBuster System (I-Flow Corporation, Lake Forest, CA, USA) provides an attractive alternative for this group of patients. We had previously demonstrated its analgesic efficacy after open hepatic surgery in a randomized controlled trial. Recently, our group had reported, in a retrospective cohort, that successful implementation of ERAS protocol was associated with a significantly shorten hospital stay. However, there was no direct comparison with convention peri-operative program in a randomized controlled manner. Moreover, the peri-operative management in that study incorporated only a small proportion of components described in ERAS programs for liver surgery, namely pre-operative counselling, no premedication, normothermia during surgery, no nasogastric tube and no routine abdominal drain. Furthermore, patient-controlled morphine analgesia was the method for post-operative pain control, which might not be enough for open hepatectomy and might have restricted the mobilization.
- Conditions
- Liver Cancer
- Being tested
- Fast-track peri-operative program
- Keywords
- Liver, Digestive system
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast-track peri-operative programOther
Also called Enhanced recovery after surgery(ERAS) peri-operative program
Patients who are scheduled for elective liver resection will be screened in clinic or in wards for the eligibility for ERAS program. Patient will then visit a nurse-led clinic for pre-operative assessment of risk adjustment and education. A guided tour on surgical ward and an information booklet about preoperative management will be given.
All patients will receive local infiltration of local anaesthesia (0.25% levobupivacaine) followed by continuous wound instillation using the On-Q PainBuster System balloon pump. Pain control will be supplemented by using opioid-sparing multimodal analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Fast-track Arm | Experimental | Patients recruited will undergo ERAS perioperative program. Receives: Other: Fast-track peri-operative program |
| Conventional Group | No intervention | Patients recruited to conventional group will undergo conventional perioperative program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of post-operative hospital Stay
Post-operative hospital stay.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start1 Jul 2018
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charing Chong, MD, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223818
- Sponsor's protocol ID
- Fast-track_Liver Resection
- Status last verified
- Apr 2022
- First submitted
- 11 Nov 2015
- Last updated
- 12 Apr 2022
- 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 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Fast-track Perioperative Program on the Clinical and Immunological Outcomes After Liver Resection in Hong Kong Chinese Patients: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03223818
- Acronym / sponsor ID
- Fast-track_Liver Resection
- Conditions
- Liver Cancer
- Keywords
- Liver, Digestive system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 21 Jul 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.
Liver cancer was the third leading cause of cancer death in both sexes in Hong Kong and liver resection remains the mainstay of curative treatment. Post-operative recovery from liver resection has historically been fraught with a high incidence of complications, ranging from 15-48%, and the high incidence of complications leads to prolonged hospital stay, ranging from 9 - 15 days, and increase costs of hospitalization. Recent advancement in the perioperative surgical and anesthetic management of patients undergoing liver resection has led to improvement in these outcomes.
The investigators department had previously studied the impact and confirmed the benefit of fast-track peri-operative programs after laparoscopic colorectal surgery. Nevertheless, studies regarding its adoption in liver resection are limited. The investigators group had previously reported, in a retrospective cohort, that successful implementation of ERAS protocol was associated with a significantly shorten hospital stay. However, the peri-operative management in that study incorporated a small proportion of components described in ERAS programs for liver resection and there was no direct comparison with conventional peri-operative program.
The aim of this study is to compare the clinical and immunological outcomes of Hong Kong Chinese patients undergoing liver resection for liver cancer with a "conventional" vs a "fast-track" perioperative program.
Detailed description
Liver cancer was the third leading cause of cancer death in both sexes in Hong Kong and liver resection remains the mainstay of curative treatment. Post-operative recovery from liver resection has historically been fraught with a high incidence of complications, ranging from 15-48%, and the high incidence of complications leads to prolonged hospital stay, ranging from 9 - 15 days, and increase costs of hospitalization. Recent advancement in the perioperative surgical and anesthetic management of patients undergoing liver resection has led to improvement in these outcomes.
Since its formal introduction in 1990s, fast-track or enhanced recovery after surgery (ERAS) peri-operative programs have gained territory quickly because of the associated cost efficiency derived from the reduction in hospital stay, an important issue in today's context of rapidly increasing health care costs and the consequent need for optimization. The benefits of fast-track peri-operative programs have been well proven in colectomy. Our department had previously demonstrated the feasibility and impact of fast-track peri-operative programs after laparoscopic colorectal surgery, which leads to the potential for application to other subspecialties. Nevertheless, studies evaluating fast-track peri-operative programs in liver resection are scarce. Most of them were carried out in Western countries and almost all of them used epidural analgesia for post-operative pain control. While most of the livers in Western patients are non-cirrhotic, the main challenge of liver resection in Chinese Hong Kong patients is the background liver cirrhosis as hepatitis-related hepatocellular carcinoma is the most common indication for liver resection. Although epidural analgesia has been showed to be effective after liver resection without complication, the debate on epidural analgesia continues. Coagulopathy, thrombocytopenia and other haematological abnormalities may impose additional risks of epidural hematoma formation following removal of the epidural catheter postoperatively. Especially there is a much greater incidence of co-existing liver cirrhosis in Chinese Hong Kong patients with hepatocelluar carcinoma. This group of patients is coagulopathic even before liver resection and the risk of bleeding complications related to epidural analgesia is a particular concern. Continuous wound instillation with local anesthetic agent by the ON-Q PainBuster System (I-Flow Corporation, Lake Forest, CA, USA) provides an attractive alternative for this group of patients. We had previously demonstrated its analgesic efficacy after open hepatic surgery in a randomized controlled trial. Recently, our group had reported, in a retrospective cohort, that successful implementation of ERAS protocol was associated with a significantly shorten hospital stay. However, there was no direct comparison with convention peri-operative program in a randomized controlled manner. Moreover, the peri-operative management in that study incorporated only a small proportion of components described in ERAS programs for liver surgery, namely pre-operative counselling, no premedication, normothermia during surgery, no nasogastric tube and no routine abdominal drain. Furthermore, patient-controlled morphine analgesia was the method for post-operative pain control, which might not be enough for open hepatectomy and might have restricted the mobilization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast-track Arm | Experimental | Other: Fast-track peri-operative programPatients recruited will undergo ERAS perioperative program. |
| Conventional Group | No intervention | –Patients recruited to conventional group will undergo conventional perioperative program |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All consecutive patients undergoing elective liver resection (open and laparoscopic).
- Age of patients between 18 and 70 years.
- Patients with American Society of Anaesthesiologists (ASA) grading I-II.
- Patients with no severe physical disability.
- Patients who require no assistance on the activities of daily living.
Key exclusion criteria (6 listed)
- Patients undergoing emergency surgery.
- Patients who had received pre-operative portal vein embolization.
- Patients who are expected to receive concomitant procedures other than cholecystectomy.
- Pregnant ladies and patients who are mentally incapable of written consent will be excluded.
- Patient who had previous history of Hepato-biliary and pancreatic surgery.
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 |
|---|---|---|
| Fast-track peri-operative programAlso: Enhanced recovery after surgery(ERAS) peri-operative programPatients who are scheduled for elective liver resection will be screened in clinic or in wards for the eligibility for ERAS program. Patient will then visit a nurse-led clinic for pre-operative assessment of risk adjustment and education. A guided tour on surgical ward and an information booklet about preoperative management will be given. All patients will receive local infiltration of local anaesthesia (0.25% levobupivacaine) followed by continuous wound instillation using the On-Q PainBuster System balloon pump. Pain control will be supplemented by using opioid-sparing multimodal analgesia. | Other | Fast-track Arm |
Primary outcome
Length of post-operative hospital Stay
Time frame: 3 months
Post-operative hospital stay.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- 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.
CREC contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast-track peri-operative program in people with Liver Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 6 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 12 Apr 2022. 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 Hong Kong. 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 CHING NING CHONG (2632 1496, chongcn@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of post-operative hospital Stay (time frame: 3 months). 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 12 Apr 2022.