Hepatocellular CarcinomaNCT01759901
Effect of Vascular Inflow Occlusion in Open Liver Resection for Hepatocellular Carcinoma
A study testing Pringle in people with Hepatocellular Carcinoma, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
Bleeding is a major problem during liver resection. Vascular inflow occlusion, also known as Pringle maneuver, has been commonly employed to reduce blood loss during liver surgery. However, Pringle maneuver might cause ischaemic insult to the remnant liver and lead to post-operative liver dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Pringle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18
- Child's A or B cirrhosis
Who cannot join
- Informed consent not available
- Presence of portal vein thrombosis, portal vein tumor thrombus, or previous portal vein embolisation
- Presence of hepatic artery thrombosis, previous transarterial therapy like TACE, lipiodol-ethanol mixture injection or transarterial internal radiation
- Anticipation of portal vein resection
- Emergency hepatectomy
- Ruptured HCC
- Adhesion or anatomical variation that preclude safe and successful application of Pringle maneuver
- Anticipation of concomitant bowel or bile duct resection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Liver Resection With or Without Vascular Inflow Occlusion for Hepatocellular Carcinoma: a Randomized Controlled Trial
Bleeding is a major problem during liver resection. Vascular inflow occlusion, also known as Pringle maneuver, has been commonly employed to reduce blood loss during liver surgery. However, Pringle maneuver might cause ischaemic insult to the remnant liver and lead to post-operative liver dysfunction.
The investigators hypothesize that liver resection without the use of vascular inflow occlusion (Pringle maneuver) is associated with lower postoperative complications rate.
Read more
The aim of this study is to evaluate whether elective open liver resection without vascular inflow occlusion (Pringle Maneuvre) would lead to a reduction of post-operative surgical complications in patient with hepatocellular carcinoma.
Eligible patients undergoing liver resection in the Prince of Wales Hospital will be recruited and randomized into 2 study arms comparing the effect of Pringle maneuver.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Pringle
- Keywords
- hepatectomy, vascular inflow occlusion
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PringleProcedure or surgery
Also called Vascular inflow occlusion
Vascular clamp is applied across hepatoduodenal ligament intermittently in 15 minutes on / 5 minutes off interval
| Study group | Role | What they receive |
|---|---|---|
| Pringle | Experimental | Intermittent vascular inflow occlusion applied during liver resection Receives: Procedure: Pringle |
| Non-Pringle | No intervention | No vascular inflow occlusion applied during liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative surgical complications
30-day morbidity after open liver resection, which includes ascites, pleural effusion, wound infection and intra-abdominal collection
Measured: 1 month
Secondary outcomes (3)
Other post-operative complications
post-operative liver failure, post-op mortality, operative blood loss, duration of operation and hospital stay
Measured: 1 month
Survival
Overall and disease-free survival at 1, 3, 5-year
Measured: 5 year
Recurrence rate of hepatocellular carcinoma
Recurrence rate of hepatocellular carcinoma at 1,3,5 year
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheung Yue Sun, Chinese University of Hong Kong
- Investigators
- Kit Fai Lee, MBBS, Principal investigator, Clinical Associate Professor (honorary)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759901
- Sponsor's protocol ID
- CRE-2012.351-T
- Status last verified
- Mar 2022
- First submitted
- 1 Jan 2013
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee KF, Chong CCN, Cheung SYS, Wong J, Fung AKY, Lok HT, Lai PBS. Impact of Intermittent Pringle Maneuver on Long-Term Survival After Hepatectomy for Hepatocellular Carcinoma: Result from Two Combined Randomized Controlled Trials. World J Surg. 2019 Dec;43(12):3101-3109. doi: 10.1007/s00268-019-05130-8.
PubMed 31420724Lee KF, Wong J, Cheung SYS, Chong CCN, Hui JWY, Leung VYF, Yu SCH, Lai PBS. Does Intermittent Pringle Maneuver Increase Postoperative Complications After Hepatectomy for Hepatocellular Carcinoma? A Randomized Controlled Trial. World J Surg. 2018 Oct;42(10):3302-3311. doi: 10.1007/s00268-018-4637-3.
PubMed 29696328
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Liver Resection With or Without Vascular Inflow Occlusion for Hepatocellular Carcinoma: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01759901
- Acronym / sponsor ID
- CRE-2012.351-T
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatectomy, vascular inflow occlusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 3 Jan 2013 (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.
Bleeding is a major problem during liver resection. Vascular inflow occlusion, also known as Pringle maneuver, has been commonly employed to reduce blood loss during liver surgery. However, Pringle maneuver might cause ischaemic insult to the remnant liver and lead to post-operative liver dysfunction.
The investigators hypothesize that liver resection without the use of vascular inflow occlusion (Pringle maneuver) is associated with lower postoperative complications rate.
The aim of this study is to evaluate whether elective open liver resection without vascular inflow occlusion (Pringle Maneuvre) would lead to a reduction of post-operative surgical complications in patient with hepatocellular carcinoma.
Eligible patients undergoing liver resection in the Prince of Wales Hospital will be recruited and randomized into 2 study arms comparing the effect of Pringle maneuver.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pringle | Experimental | Procedure: PringleIntermittent vascular inflow occlusion applied during liver resection |
| Non-Pringle | No intervention | –No vascular inflow occlusion applied during liver resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18
- Child's A or B cirrhosis
Key exclusion criteria (8 listed)
- Informed consent not available
- Presence of portal vein thrombosis, portal vein tumor thrombus, or previous portal vein embolisation
- Presence of hepatic artery thrombosis, previous transarterial therapy like TACE, lipiodol-ethanol mixture injection or transarterial internal radiation
- Anticipation of portal vein resection
- Emergency hepatectomy
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 |
|---|---|---|
| PringleAlso: Vascular inflow occlusionVascular clamp is applied across hepatoduodenal ligament intermittently in 15 minutes on / 5 minutes off interval | Procedure or surgery | Pringle |
Primary outcome
Post-operative surgical complications
Time frame: 1 month
30-day morbidity after open liver resection, which includes ascites, pleural effusion, wound infection and intra-abdominal collection
3 secondary outcomes
Other post-operative complications
Time frame: 1 month
Survival
Time frame: 5 year
Recurrence rate of hepatocellular carcinoma
Time frame: 5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Derived from this study: PubMed 31420724Lee KF, Chong CCN, Cheung SYS, Wong J, Fung AKY, Lok HT, Lai PBS. Impact of Intermittent Pringle Maneuver on Long-Term Survival After Hepatectomy for Hepatocellular Carcinoma: Result from Two Combined Randomized Controlled Trials. World J Surg. 2019 Dec;43(12):3101-3109. doi: 10.1007/s00268-019-05130-8.
- Derived from this study: PubMed 29696328Lee KF, Wong J, Cheung SYS, Chong CCN, Hui JWY, Leung VYF, Yu SCH, Lai PBS. Does Intermittent Pringle Maneuver Increase Postoperative Complications After Hepatectomy for Hepatocellular Carcinoma? A Randomized Controlled Trial. World J Surg. 2018 Oct;42(10):3302-3311. doi: 10.1007/s00268-018-4637-3.
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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.
Kit Fai Lee, MBBS principal investigator
Clinical Associate Professor (honorary)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pringle in people with Hepatocellular Carcinoma, run by Chinese University of Hong Kong 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 18 Mar 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Post-operative surgical complications (time frame: 1 month). 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 NCT01759901, which also lists 2 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 18 Mar 2022.