Colorectal ObstructionNCT00514332
Comparison Between Colorectal Stents and Primary Surgery in Obstructive Colonic Cancer. A Randomized, Controlled Study
A study testing stent in people with Colorectal Obstruction and Left Colonic Adenocarcinoma, run by University Hospital, Montpellier.
Trial summary
To evaluate wether colorectal stenting carry a significant clinical advantage Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Obstruction, Left Colonic Adenocarcinoma
- What is being tested?
- stent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to Oct 2006
- 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
- obstructive stenosis due to left colorectal cancer
Who cannot join
- previous colorectal cancer
- other colorectal location
About this study
Official title: Etude Prospective Multicentrique randomisée Comparant Deux stratégies thérapeutiques Pour Les Cancers Coliques en Occlusion : stratégie Chirurgicale Exclusive Versus stratégie thérapeutique Avec Stent Colique Initial
To evaluate wether colorectal stenting carry a significant clinical advantage
Read the detailed description
Randomized controlled comparison between stents and primary surgery in obstructive left colonic obstructive carcinoma outside palliative situations.
- Being tested
- stent
- Keywords
- colorectal stents, colonic obstruction, colonic adenocarcinoma, colorectal surgery
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stentProcedure or surgery
Also called self-expending metallic stents
stent placement for colorectal cancer obstruction
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | primary surgery group Receives: Procedure: stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of stoma in each group
Measured: within the first 6 month(plus or minus 1 month) after surgery
Secondary outcomes (4)
mortality in each group
Measured: within the first 6 month (plus or minus 1 month) after surgery
complications
Measured: within the first 6 month (plus or minus 1 month) after surgery
number of procedures
Measured: within the first 6 month (plus or minus 1 month) after surgery
length of stay
Measured: within the first 6 month (plus or minus 1 month) after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2007 (estimated)
- Study startDec 2002
- Study completionOct 2006
Why it stopped: enrolling participants stopped
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 Colorectal ObstructionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Rouen, University Hospital, Toulouse, University Hospital, Grenoble, Rennes University Hospital, University Hospital, Lille, University Hospital, Angers, University Hospital, Bordeaux
- Investigators
- Bertrand L MILLAT, MD-PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514332
- Sponsor's protocol ID
- UF7683
- Status last verified
- Aug 2007
- First submitted
- 8 Aug 2007
- Last updated
- 9 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Pirlet IA, Slim K, Kwiatkowski F, Michot F, Millat BL. Emergency preoperative stenting versus surgery for acute left-sided malignant colonic obstruction: a multicenter randomized controlled trial. Surg Endosc. 2011 Jun;25(6):1814-21. doi: 10.1007/s00464-010-1471-6. Epub 2010 Dec 18.
PubMed 21170659
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude Prospective Multicentrique randomisée Comparant Deux stratégies thérapeutiques Pour Les Cancers Coliques en Occlusion : stratégie Chirurgicale Exclusive Versus stratégie thérapeutique Avec Stent Colique Initial
- ClinicalTrials.gov ID
- NCT00514332
- Acronym / sponsor ID
- UF7683
- Keywords
- colorectal stents, colonic obstruction, colonic adenocarcinoma, colorectal surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: enrolling participants stopped
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- University Hospital, Rouen, University Hospital, Toulouse, University Hospital, Grenoble, Rennes University Hospital, University Hospital, Lille, University Hospital, Angers, University Hospital, Bordeaux
- Study start
- Dec 2002
- Study completion
- Oct 2006 (actual)
- First posted
- 9 Aug 2007 (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.
To evaluate wether colorectal stenting carry a significant clinical advantage
Detailed description
Randomized controlled comparison between stents and primary surgery in obstructive left colonic obstructive carcinoma outside palliative situations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: stentprimary surgery group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- obstructive stenosis due to left colorectal cancer
Key exclusion criteria (2 listed)
- previous colorectal cancer
- other colorectal location
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 |
|---|---|---|
| stentAlso: self-expending metallic stentsstent placement for colorectal cancer obstruction | Procedure or surgery | A |
Primary outcome
number of stoma in each group
Time frame: within the first 6 month(plus or minus 1 month) after surgery
4 secondary outcomes
mortality in each group
Time frame: within the first 6 month (plus or minus 1 month) after surgery
complications
Time frame: within the first 6 month (plus or minus 1 month) after surgery
number of procedures
Time frame: within the first 6 month (plus or minus 1 month) after surgery
length of stay
Time frame: within the first 6 month (plus or minus 1 month) after surgery
Results and safety
The study was stopped early (reason given: enrolling participants stopped). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2007.
- Derived from this study: PubMed 21170659Pirlet IA, Slim K, Kwiatkowski F, Michot F, Millat BL. Emergency preoperative stenting versus surgery for acute left-sided malignant colonic obstruction: a multicenter randomized controlled trial. Surg Endosc. 2011 Jun;25(6):1814-21. doi: 10.1007/s00464-010-1471-6. Epub 2010 Dec 18.
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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.
Bertrand L MILLAT, MD-PhD principal investigator
University Hospital, Montpellier
Questions about this trial
What is this clinical trial studying?
A study testing stent in people with Colorectal Obstruction and Left Colonic Adenocarcinoma, run by University Hospital, Montpellier.
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 1 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: stopped early, as of the sponsor's last update on 9 Aug 2007. 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 was stopped early (reason given: enrolling participants stopped). 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 stoma in each group (time frame: within the first 6 month(plus or minus 1 month) after surgery). 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 NCT00514332, 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 9 Aug 2007.