Colorectal CancerPhase 3NCT01842971
ALPPS (Liver Partition and Portal Vein Ligation) for Two-stage Hepatectomy for Colorectal Liver Metastasis
A Phase 3 study testing two stage hepatectomy in people with Colorectal Cancer, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The aim of this study is evaluate the feasibility of early two-stage hepatectomy in patients with liver metastasis from colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- two stage hepatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2013to 13 Dec 2016
- Phase
- Phase 3
- 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
- potentially resectable liver metastasis from colorectal cancer
- portal embolisation required
- older than 18 years old
Who cannot join
- synchronous surgery on the colon or the rectum
- extra hepatic metastasis
- history of hepatectomy
- pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Associating Liver Partition and Portal Vein Ligation (ALPPS) for Potentially Resectable Liver Metastasis From Colorectal Cancer: Prospective Evaluation of the Early Two-stage Hepatectomy by the Simon's Methods
The aim of this study is evaluate the feasibility of early two-stage hepatectomy in patients with liver metastasis from colorectal cancer.
Read the detailed description
In France, each year around 36,000 new cases of colorectal cancers are registered responsible in 16,000 deaths because of liver metastasis.
In case of bilobar metastasis, classic two-stage hepatectomy with portal embolization could be performed.
An alternative to the classic surgery, early two stage hepatectomy, could be proposed to simplify the patient's management and to improve the resectability.
- Conditions
- Colorectal Cancer
- Being tested
- two stage hepatectomy
- Keywords
- two stage hepatectomy, liver metastasis, colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two stage hepatectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| two stage hepatectomy | Experimental | the two stage hepatectomy is defined as a two step procedure: first step: hepatotomy with ligature of the right branch of the portal vein second step (one week after the first step): right hepatectomy Receives: Procedure: two stage hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of complete surgical procedure
the number of complete surgical procedure is defined as the number of patients in whom the two stage hepatectomy is complete.
Measured: postoperative week 4
Secondary outcomes (5)
overall mortality
the overall mortality is defined as the number of patients who are dead at one year after the surgery
Measured: one year after the two stage hepatectomy
number of patient with hepatocellular insufficiency
the hepatocellular insufficiency is defined by a prothrombin rate below 50%
Measured: postoperative day 30
overall morbidity
the overall morbidity is classified according to the Dindo Clavien classification
Measured: postoperative day 30
preoperative liver volumetry
the remnant liver volume is evaluated with the Myrian Software and calculated by the radiologist
Measured: one week prior to the surgery
quality of life
the quality of life is evaluated thanks to the EORTC QLQ C30 LMC 21 form the day before the first stage surgery and the day before the second stage surgery.
Measured: the day before the first stage surgery and the day before the second stage surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study start7 Jun 2013
- Primary completion13 Dec 2016
- Study completion13 Dec 2016
Why it stopped: Main reason: negative echo in the literature after the first publications.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jean marc regimbeau, MD, PhD, Principal investigator, Amiens University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842971
- Sponsor's protocol ID
- PI2012_843_0028
- Other IDs
- A41707-36
- Status last verified
- Jul 2018
- First submitted
- 24 Apr 2013
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associating Liver Partition and Portal Vein Ligation (ALPPS) for Potentially Resectable Liver Metastasis From Colorectal Cancer: Prospective Evaluation of the Early Two-stage Hepatectomy by the Simon's Methods
- ClinicalTrials.gov ID
- NCT01842971
- Acronym / sponsor ID
- PI2012_843_0028
- Conditions
- Colorectal Cancer
- Keywords
- two stage hepatectomy, liver metastasis, colorectal cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Main reason: negative echo in the literature after the first publications.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 7 Jun 2013 (actual)
- Primary completion
- 13 Dec 2016 (actual)
- Study completion
- 13 Dec 2016 (actual)
- First posted
- 30 Apr 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.
The aim of this study is evaluate the feasibility of early two-stage hepatectomy in patients with liver metastasis from colorectal cancer.
Detailed description
In France, each year around 36,000 new cases of colorectal cancers are registered responsible in 16,000 deaths because of liver metastasis.
In case of bilobar metastasis, classic two-stage hepatectomy with portal embolization could be performed.
An alternative to the classic surgery, early two stage hepatectomy, could be proposed to simplify the patient's management and to improve the resectability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| two stage hepatectomy | Experimental | Procedure: two stage hepatectomythe two stage hepatectomy is defined as a two step procedure: first step: hepatotomy with ligature of the right branch of the portal vein second step (one week after the first step): right hepatectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- potentially resectable liver metastasis from colorectal cancer
- portal embolisation required
- older than 18 years old
Key exclusion criteria (4 listed)
- synchronous surgery on the colon or the rectum
- extra hepatic metastasis
- history of hepatectomy
- pregnancy or breastfeeding
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 |
|---|---|---|
| two stage hepatectomy | Procedure or surgery | two stage hepatectomy |
Primary outcome
number of complete surgical procedure
Time frame: postoperative week 4
the number of complete surgical procedure is defined as the number of patients in whom the two stage hepatectomy is complete.
5 secondary outcomes
overall mortality
Time frame: one year after the two stage hepatectomy
number of patient with hepatocellular insufficiency
Time frame: postoperative day 30
overall morbidity
Time frame: postoperative day 30
preoperative liver volumetry
Time frame: one week prior to the surgery
quality of life
Time frame: the day before the first stage surgery and the day before the second stage surgery
Results and safety
The study was stopped early (reason given: Main reason: negative echo in the literature after the first publications.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
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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.
jean marc regimbeau, MD, PhD principal investigator
Amiens University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing two stage hepatectomy in people with Colorectal Cancer, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 3 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: stopped early, as of the sponsor's last update on 2 Aug 2018. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Main reason: negative echo in the literature after the first publications.). Results are not available in the source record.
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?
number of complete surgical procedure (time frame: postoperative week 4). 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 2 Aug 2018.