HepatectomyNCT00730743
Study on Clinical Outcome of Vascular Inflow Occlusion in Open Liver Resection
A study testing Intermittent Pringle maneuver in people with Hepatectomy, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
This study aims to evaluate whether applying inflow vascular occlusion in modern liver resection is associated with better clinical outcome. Eligible patients are randomly assigned to the two surgical techniques: with or without the application of inflow vascular occlusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatectomy
- What is being tested?
- Intermittent Pringle maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- May 2008to Aug 2011
- 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 years
- Child-Pugh Class A or B
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, or transarterial internal radiation
- When portal vein resection is anticipated
- Emergency hepatectomy
- Ruptured hepatocellular carcinoma
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- Rehepatectomy (repeated liver resection)
- Adhesion or anatomical variation that preclude safe and successful application of Pringle maneuver
- When concomitant bowel or bile duct resection is anticipated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Liver Resection With or Without Vascular Inflow Occlusion: a Randomized Control Trial
This study aims to evaluate whether applying inflow vascular occlusion in modern liver resection is associated with better clinical outcome.
Eligible patients are randomly assigned to the two surgical techniques: with or without the application of inflow vascular occlusion.
Patients outcome including liver function recovery, operative time and blood loss are compared.
- Conditions
- Hepatectomy
- Being tested
- Intermittent Pringle maneuver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Pringle maneuverProcedure or surgery
Pringle maneuver is performed by isolation of the hepatoduodenal ligament which is then encircled and occluded with atraumatic vascular clamp. The clamp is applied for 15 minutes followed by unclamping for 5 minutes and repeated till end of liver transection. Limits of clamp cycle: 3 cycles for cirrhotic liver; 4 cycles for non-cirrhotic liver.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intermittent clamp group Receives: Procedure: Intermittent Pringle maneuver |
| 2 | No intervention | No clamp group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative blood loss
Measured: From skin incision to completion of operation
Operative time
Measured: From skin incision to completion of operation
Secondary outcomes (2)
Operative morbidity and mortality
Measured: From date of operation to 30-day after operation
Recovery of liver function
Measured: From date of operation to date of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2011
- Study completionAug 2011
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 HepatectomyStudies 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
- 126 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, Departement of Surgery, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730743
- Sponsor's protocol ID
- CT08017
- Other IDs
- CRE-2008.037-T
- Status last verified
- Feb 2015
- First submitted
- 6 Aug 2008
- Last updated
- 4 Feb 2015
- 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, Cheung YS, Wong J, Chong CC, Wong JS, Lai PB. Randomized clinical trial of open hepatectomy with or without intermittent Pringle manoeuvre. Br J Surg. 2012 Sep;99(9):1203-9. doi: 10.1002/bjs.8863. Epub 2012 Jul 24.
PubMed 22828986
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Liver Resection With or Without Vascular Inflow Occlusion: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT00730743
- Acronym / sponsor ID
- CT08017
- Conditions
- Hepatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 8 Aug 2008 (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.
This study aims to evaluate whether applying inflow vascular occlusion in modern liver resection is associated with better clinical outcome.
Eligible patients are randomly assigned to the two surgical techniques: with or without the application of inflow vascular occlusion.
Patients outcome including liver function recovery, operative time and blood loss are compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Intermittent Pringle maneuverIntermittent clamp group |
| 2 | No intervention | –No clamp group |
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 years
- Child-Pugh Class A or B
Key exclusion criteria (9 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, or transarterial internal radiation
- When portal vein resection is anticipated
- 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 |
|---|---|---|
| Intermittent Pringle maneuverPringle maneuver is performed by isolation of the hepatoduodenal ligament which is then encircled and occluded with atraumatic vascular clamp. The clamp is applied for 15 minutes followed by unclamping for 5 minutes and repeated till end of liver transection. Limits of clamp cycle: 3 cycles for cirrhotic liver; 4 cycles for non-cirrhotic liver. | Procedure or surgery | 1 |
Primary outcome
Operative blood loss
Time frame: From skin incision to completion of operation
Operative time
Time frame: From skin incision to completion of operation
2 secondary outcomes
Operative morbidity and mortality
Time frame: From date of operation to 30-day after operation
Recovery of liver function
Time frame: From date of operation to date of discharge
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 4 Feb 2015.
- 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 22828986Lee KF, Cheung YS, Wong J, Chong CC, Wong JS, Lai PB. Randomized clinical trial of open hepatectomy with or without intermittent Pringle manoeuvre. Br J Surg. 2012 Sep;99(9):1203-9. doi: 10.1002/bjs.8863. Epub 2012 Jul 24.
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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
Departement of Surgery, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Pringle maneuver in people with Hepatectomy, 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 9 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 4 Feb 2015. 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?
Operative blood loss (time frame: From skin incision to completion of operation). The study lists 2 primary outcomes in all. 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 NCT00730743, 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 4 Feb 2015.