Liver MetastasisNCT02042794
Pringle Manoeuvre Versus Portal Vein Clamping for Liver Resection
An observational study of Liver Metastasis, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Liver resection is an operation to remove the diseased part of the liver. The liver is supplied by two vessels, the hepatic artery and the portal vein supplying 25% and 75% respectively of the total blood flow with 50% oxygen from each vessel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastasis
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2013to Dec 2015
- Phase
- Observational
- 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
Study population: Cancer, inflammatory and immune study, oral and gastrointestinal.
Who may be able to join
- At least 18 years of age
- Undergoing liver resection for CRLM
- Portal venous clamping as considered appropriate
- Participating patients should be able to understand the study objectives and be able to give written consent
- Able to complete study questionnaire
Who cannot join
- Patients having simultaneous bowel and hepatic surgery
- Patients participating in other trials that could impact the outcomes measures being recorded
- Patients who are pregnant
- Patients taking immunosuppressive medication
Trial locations and contacts
1 site in 1 country.
Raj Prasad contact
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
Raj Prasad, raj.prasad@leedsth.nhs.uk
About this study
Official title: Randomised Controlled Trial of Pringle Manoeuvre Versus Portal Vein Clamping in Patients Undergoing Liver Resection for Colorectal Liver Metastasis - A Pilot Study
Liver resection is an operation to remove the diseased part of the liver. The liver is supplied by two vessels, the hepatic artery and the portal vein supplying 25% and 75% respectively of the total blood flow with 50% oxygen from each vessel. During liver resection it is standard practice to clamp both vessels(Pringle's manoeuvre), so as to avoid bleeding. Clamping both the vessels deprives the unaffected liver from nutrients required for survival. Reinstating the blood supply causes further damage by pouring harmful substances into the liver, which accumulate during the clamping. We hypothesize that not clamping the oxygen rich hepatic artery will cause less damage to the liver.
Our aim is to compare the Pringle manoeuvre with portal vein clamping, to identify if the latter will result in less tissue injury and thereby fewer complications. Initially we aim to conduct a pilot study. The main objective is to ensure that patients can be successfully recruited and that data capture is complete. The secondary outcomes will be development of infective complications by 30 days following surgery, bleeding and blood transfusion requirements, heart/chest complications, recovery of liver functions, growth of remnant liver, death within 30 days following surgery, length of high dependency unit/hospital stay and quality of life at 3 months after surgery.
There is published literature on the safety of this method and in the event of any intraoperative problems, the procedure will be converted to the standard Pringle manoeuvre. The Liver Unit at St James's University Hospital has four surgeons performing around 270 liver cancer resections per year, of which nearly 160 are for bowel cancer spread. Considering the team's experience in research and liver surgery, we believe it is well placed to conduct the trial in a safe and efficient manner.
- Conditions
- Liver Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability to recruit and randomise patients into the study
Measured: 14months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startJun 2013
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver MetastasisStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042794
- Sponsor's protocol ID
- PB-PG-0711-25080
- Status last verified
- Feb 2015
- First submitted
- 16 Jan 2014
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Pringle Manoeuvre Versus Portal Vein Clamping in Patients Undergoing Liver Resection for Colorectal Liver Metastasis - A Pilot Study
- ClinicalTrials.gov ID
- NCT02042794
- Acronym / sponsor ID
- PB-PG-0711-25080
- Conditions
- Liver Metastasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2015 (estimated)
- First posted
- 23 Jan 2014 (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.
Liver resection is an operation to remove the diseased part of the liver. The liver is supplied by two vessels, the hepatic artery and the portal vein supplying 25% and 75% respectively of the total blood flow with 50% oxygen from each vessel. During liver resection it is standard practice to clamp both vessels(Pringle's manoeuvre), so as to avoid bleeding. Clamping both the vessels deprives the unaffected liver from nutrients required for survival. Reinstating the blood supply causes further damage by pouring harmful substances into the liver, which accumulate during the clamping. We hypothesize that not clamping the oxygen rich hepatic artery will cause less damage to the liver.
Our aim is to compare the Pringle manoeuvre with portal vein clamping, to identify if the latter will result in less tissue injury and thereby fewer complications. Initially we aim to conduct a pilot study. The main objective is to ensure that patients can be successfully recruited and that data capture is complete. The secondary outcomes will be development of infective complications by 30 days following surgery, bleeding and blood transfusion requirements, heart/chest complications, recovery of liver functions, growth of remnant liver, death within 30 days following surgery, length of high dependency unit/hospital stay and quality of life at 3 months after surgery.
There is published literature on the safety of this method and in the event of any intraoperative problems, the procedure will be converted to the standard Pringle manoeuvre. The Liver Unit at St James's University Hospital has four surgeons performing around 270 liver cancer resections per year, of which nearly 160 are for bowel cancer spread. Considering the team's experience in research and liver surgery, we believe it is well placed to conduct the trial in a safe and efficient manner.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer, inflammatory and immune study, oral and gastrointestinal.
Key inclusion criteria (5 listed)
- At least 18 years of age
- Undergoing liver resection for CRLM
- Portal venous clamping as considered appropriate
- Participating patients should be able to understand the study objectives and be able to give written consent
- Able to complete study questionnaire
Key exclusion criteria (4 listed)
- Patients having simultaneous bowel and hepatic surgery
- Patients participating in other trials that could impact the outcomes measures being recorded
- Patients who are pregnant
- Patients taking immunosuppressive medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The ability to recruit and randomise patients into the study
Time frame: 14months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
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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.
Raj Prasad contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Metastasis, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 23 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 United Kingdom. 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 Raj Prasad (raj.prasad@leedsth.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ability to recruit and randomise patients into the study (time frame: 14months). 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 23 Feb 2015; AzTrials last refreshed its copy on 8 Nov 2026.