Liver CancerNCT03168230
Impact of PVE on Patient's Long-term Survival, Complications and Cancer Recurrence.
An observational study of Liver Cancer and Liver Metastases, run by Université de Sherbrooke.
Trial summary
For patients with colorectal liver metastasis (CLM), the prospect of long-term survival relies on liver resection. Wistfully, more than 75 % of patients with CLM are initially unresectable, due to an insufficient future liver remnant (FLR) volume In order to increase FLR volume, most patients will first receive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Liver Metastases
- What is being tested?
- Portal vein embolization (PVE)
- Type of treatment
- Surgery or procedure
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 27 Feb 2004to 21 May 2016
- 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: Adult patients (≥18 years old) affected by colorectal liver metastasis (CLM) and scheduled for a one-stage right/extended right hepatectomy in Centre Hospitalier Universitaire de Montréal (CHUS) - Hospital Saint-Luc.
Who may be able to join
None listed.
Who cannot join
- Individuals requiring a two-stage hepatectomy.
- Patient who had previous hepatectomy.
About this study
Official title: Impact of Portal Vein Embolization on Patient's Long-term Survival, Complications and Cancer Recurrence.
For patients with colorectal liver metastasis (CLM), the prospect of long-term survival relies on liver resection. Wistfully, more than 75 % of patients with CLM are initially unresectable, due to an insufficient future liver remnant (FLR) volume
In order to increase FLR volume, most patients will first receive chemotherapy to reduce the tumor load (downsizing).
Read more
When chemotherapy is insufficient to provide an adequate postoperative FLR, portal vein embolization (PVE) can be performed. About 50-70 % of patients undergoing PVE obtain a sufficient liver hypertrophy to allow liver resection.
While PVE is recognised for its efficacy to induce liver hypertrophy, some studies expressed substantial concerns regarding the potential adverse effect of this intervention on pre-resection tumor progression, increased risk of cancer recurrence following resection and reduced overall survival following resection
Those studies suggested that the need to perform PVE should be assessed thoroughly for each patient and that chemotherapy should be maintained during the whole hypertrophy process in order to contain the potential adverse effect of PVE on tumor progression.
Other studies found no significant association between PVE and negative oncological outcomes.
As mentioned in almost every study cited above, more data is needed to provide a clearer vision regarding the impact of PVE on tumor progression and cancer recurrence following liver resection.
The aim of this study is to compare the overall and disease-free survival of PVE-requiring patients to the ones who underwent upfront surgery (NoPVE).
As a secondary objective, the impact of several covariates (related to surgery, patient's condition and disease stage) on survival and cancer recurrence will be tested.
Our hypothesis are that 1) PVE might be associated with a lower overall survival and a higher risk of cancer recurrence in univariate analysis but 2) this association will not remain significant when other covariates are included in the proportional COX hazard models.
- Conditions
- Liver Cancer, Liver Metastases
- Being tested
- Portal vein embolization (PVE)
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portal vein embolization (PVE)Procedure or surgery
Portal vein embolization (PVE) is a procedure that induces regrowth on one side of the liver in advance of a planned hepatic resection on the other side. The procedure is frequently used in primary liver cancer (hepatocellular carcinoma) and colorectal liver metastases.
An interventional radiologist will place a needle percutaneously (through the skin) into the liver and identify the blood vessel on the side where the largest part of the tumor is being supplied. Tiny microspheres are then infused into the portal vein which supplies blood to the area, embolizing it by cutting off its blood supply.
This blockade of the blood supply induces the other side of the liver to regrow. After several weeks, the non-embolized side has grown enough so that surgery is now a viable option.
Source of this information : http://general.surgery.ucsf.edu/conditions--procedures/portal-vein-embolization-(pve).aspx
| Study group | Role | What they receive |
|---|---|---|
| PVE | Patients who required PVE prior to the attempt of liver resection. Receives: Procedure: Portal vein embolization (PVE) | |
| No-PVE | Patients who received upfront surgery (no PVE prior to the intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 5 years
Disease-free survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start27 Feb 2004
- Primary completion21 May 2016
- Study completion21 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves Collin, MD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168230
- Sponsor's protocol ID
- 12.106
- Status last verified
- May 2017
- First submitted
- 24 May 2017
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Collin Y, Pare A, Belblidia A, Letourneau R, Plasse M, Dagenais M, Turcotte S, Martel G, Roy A, Lapointe R, Vandenbroucke-Menu F. Portal vein embolization does not affect the long-term survival and risk of cancer recurrence among colorectal liver metastases patients: A prospective cohort study. Int J Surg. 2019 Jan;61:42-47. doi: 10.1016/j.ijsu.2018.11.029. Epub 2018 Dec 8.
PubMed 30537548
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Portal Vein Embolization on Patient's Long-term Survival, Complications and Cancer Recurrence.
- ClinicalTrials.gov ID
- NCT03168230
- Acronym / sponsor ID
- 12.106
- Conditions
- Liver Cancer, Liver Metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 27 Feb 2004 (actual)
- Primary completion
- 21 May 2016 (actual)
- Study completion
- 21 May 2016 (actual)
- First posted
- 30 May 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.
For patients with colorectal liver metastasis (CLM), the prospect of long-term survival relies on liver resection. Wistfully, more than 75 % of patients with CLM are initially unresectable, due to an insufficient future liver remnant (FLR) volume
In order to increase FLR volume, most patients will first receive chemotherapy to reduce the tumor load (downsizing).
When chemotherapy is insufficient to provide an adequate postoperative FLR, portal vein embolization (PVE) can be performed. About 50-70 % of patients undergoing PVE obtain a sufficient liver hypertrophy to allow liver resection.
While PVE is recognised for its efficacy to induce liver hypertrophy, some studies expressed substantial concerns regarding the potential adverse effect of this intervention on pre-resection tumor progression, increased risk of cancer recurrence following resection and reduced overall survival following resection
Those studies suggested that the need to perform PVE should be assessed thoroughly for each patient and that chemotherapy should be maintained during the whole hypertrophy process in order to contain the potential adverse effect of PVE on tumor progression.
Other studies found no significant association between PVE and negative oncological outcomes.
As mentioned in almost every study cited above, more data is needed to provide a clearer vision regarding the impact of PVE on tumor progression and cancer recurrence following liver resection.
The aim of this study is to compare the overall and disease-free survival of PVE-requiring patients to the ones who underwent upfront surgery (NoPVE).
As a secondary objective, the impact of several covariates (related to surgery, patient's condition and disease stage) on survival and cancer recurrence will be tested.
Our hypothesis are that 1) PVE might be associated with a lower overall survival and a higher risk of cancer recurrence in univariate analysis but 2) this association will not remain significant when other covariates are included in the proportional COX hazard models.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVE | – | Procedure: Portal vein embolization (PVE)Patients who required PVE prior to the attempt of liver resection. |
| No-PVE | – | –Patients who received upfront surgery (no PVE prior to the intervention) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years old) affected by colorectal liver metastasis (CLM) and scheduled for a one-stage right/extended right hepatectomy in Centre Hospitalier Universitaire de Montréal (CHUS) - Hospital Saint-Luc.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Individuals requiring a two-stage hepatectomy.
- Patient who had previous 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 |
|---|---|---|
| Portal vein embolization (PVE)Portal vein embolization (PVE) is a procedure that induces regrowth on one side of the liver in advance of a planned hepatic resection on the other side. The procedure is frequently used in primary liver cancer (hepatocellular carcinoma) and colorectal liver metastases. An interventional radiologist will place a needle percutaneously (through the skin) into the liver and identify the blood vessel on the side where the largest part of the tumor is being supplied. Tiny microspheres are then infused into the portal vein which supplies blood to the area, embolizing it by cutting off its blood supply. This blockade of the blood supply induces the other side of the liver to regrow. After several weeks, the non-embolized side has grown enough so that surgery is now a viable option. Source of this information : http://general.surgery.ucsf.edu/conditions--procedures/portal-vein-embolization-(pve).aspx | Procedure or surgery | PVE |
Primary outcome
Overall survival
Time frame: 5 years
Disease-free survival
Time frame: 5 years
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 30 May 2017.
- Derived from this study: PubMed 30537548Collin Y, Pare A, Belblidia A, Letourneau R, Plasse M, Dagenais M, Turcotte S, Martel G, Roy A, Lapointe R, Vandenbroucke-Menu F. Portal vein embolization does not affect the long-term survival and risk of cancer recurrence among colorectal liver metastases patients: A prospective cohort study. Int J Surg. 2019 Jan;61:42-47. doi: 10.1016/j.ijsu.2018.11.029. Epub 2018 Dec 8.
- 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.
Yves Collin, MD principal investigator
Université de Sherbrooke
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer and Liver Metastases, run by Université de Sherbrooke.
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 0 inclusion and 2 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Overall survival (time frame: 5 years). 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 NCT03168230, which also lists 1 linked publication.
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 30 May 2017.