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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

CHING NING CHONG contact

2632 1496

chongcn@surgery.cuhk.edu.hk

CREC contact

crec@cuhk.edu.hk

Hong Kong1 site, 1 recruiting
  • Department of Surgery

    Hong Kong

    Charing CHONG, MBChB, 852 2632 1411, chongcn@surgery.cuhk.edu.hk

    Recruiting

Other trials in Hong Kong

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 groups in NCT03223818
Study groupRoleWhat they receive
Fast-track ArmExperimentalPatients recruited will undergo ERAS perioperative program.
Receives: Other: Fast-track peri-operative program
Conventional GroupNo interventionPatients 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.

  1. 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.

  1. First posted21 Jul 2017
  2. Study start1 Jul 2018
  3. Primary completion1 Jul 2023 (estimated)
  4. Study completion1 Jul 2025 (estimated)

Resources

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)
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

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.

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