Colorectal CancerPhase 3NCT00164879
Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers
A Phase 3 study testing Endoscopic stenting followed by elective laparoscopic resection in people with Colorectal Cancer and Bowel Obstruction, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
The aim of this study is to compare the stoma rate, clinical efficacy, and safety of patients treated by endoscopic stenting followed by elective laparoscopic resection (the 'endolaparoscopic approach') versus immediate emergency surgery for obstructing left-sided colorectal cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Bowel Obstruction
- What is being tested?
- Endoscopic stenting followed by elective laparoscopic resection
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Jan 2000to not given
- 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
- Consecutive patients with obstructing colorectal cancers, confirmed on water-soluble contrast enema or computed tomography (CT) scan
- Consented patients
Who cannot join
- Patients with peritonitis that required immediate surgical intervention
- Patients with distal rectal cancers that are not suitable for stenting
- Moribund patients, unfit for surgery otherwise
- Pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Endoscopy Centre, Prince of Wales Hospital
Hong Kong SAR
James YW Lau, MD, FRCS(Edin), (852)26322627, laujyw@netvigator.com
Simon SM Ng, FRCS Ed (Gen), (852)26322625, simonng@surgery.cuhk.edu.hk
About this study
Official title: Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers: A Randomised Trial
The aim of this study is to compare the stoma rate, clinical efficacy, and safety of patients treated by endoscopic stenting followed by elective laparoscopic resection (the 'endolaparoscopic approach') versus immediate emergency surgery for obstructing left-sided colorectal cancers.
Read the detailed description
In patients who present with obstructing left-sided colorectal cancers, emergency surgery carries a significant morbidity and mortality. Traditionally, most of these patients would receive staged operations (Hartmann's procedure). Temporary stoma is often required due to the edematous bowel wall precluding primary anastomosis as a result of obstruction and the poor pre-morbid status. A second operation is subsequently required to restore bowel continuity. Apart from the expensive hospital costs of the staged operations, the patient's acceptance to the stoma is poor and the social inconvenience associated with the stoma is obvious. Thus, a significant portion of patients would not be suitable for the second operation due to poor health or advanced disease and having to bear the stoma for the remainder of life. Recently, self-expandable metal stents have been used with success in relieving the acute obstruction in patients with obstructing left-sided colorectal cancers. Endoscopic stenting may help to relieve the obstruction, avoid emergency surgery, and allows patients to undergo one-stage elective surgery without the necessity of making a stoma. We propose to evaluate the clinical benefits of using self-expandable metal stents in patients with obstructing left-sided colorectal cancers followed by elective laparoscopic resection and compare its use to immediate emergency surgery.
- Conditions
- Colorectal Cancer, Bowel Obstruction
- Being tested
- Endoscopic stenting followed by elective laparoscopic resection
- Keywords
- Obstructing, Left-sided, Colorectal neoplasms, Obstructing left-sided colorectal cancers
- Medical subject headings
- Colorectal Neoplasms, Intestinal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic stenting followed by elective laparoscopic resectionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of relieving obstruction after stent insertion
The stoma rate in the two groups of patients
Secondary outcomes (2)
Morbidity and mortality rates in the two groups
Hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJan 2000
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- James YW Lau, MD, FRCS(Edin), Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164879
- Sponsor's protocol ID
- CRE-2002.445-T
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 7 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal Cancers: A Randomised Trial
- ClinicalTrials.gov ID
- NCT00164879
- Acronym / sponsor ID
- CRE-2002.445-T
- Conditions
- Colorectal Cancer, Bowel Obstruction
- Keywords
- Obstructing, Left-sided, Colorectal neoplasms, Obstructing left-sided colorectal cancers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jan 2000
- First posted
- 14 Sep 2005 (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 to compare the stoma rate, clinical efficacy, and safety of patients treated by endoscopic stenting followed by elective laparoscopic resection (the 'endolaparoscopic approach') versus immediate emergency surgery for obstructing left-sided colorectal cancers.
Detailed description
In patients who present with obstructing left-sided colorectal cancers, emergency surgery carries a significant morbidity and mortality. Traditionally, most of these patients would receive staged operations (Hartmann's procedure). Temporary stoma is often required due to the edematous bowel wall precluding primary anastomosis as a result of obstruction and the poor pre-morbid status. A second operation is subsequently required to restore bowel continuity. Apart from the expensive hospital costs of the staged operations, the patient's acceptance to the stoma is poor and the social inconvenience associated with the stoma is obvious. Thus, a significant portion of patients would not be suitable for the second operation due to poor health or advanced disease and having to bear the stoma for the remainder of life. Recently, self-expandable metal stents have been used with success in relieving the acute obstruction in patients with obstructing left-sided colorectal cancers. Endoscopic stenting may help to relieve the obstruction, avoid emergency surgery, and allows patients to undergo one-stage elective surgery without the necessity of making a stoma. We propose to evaluate the clinical benefits of using self-expandable metal stents in patients with obstructing left-sided colorectal cancers followed by elective laparoscopic resection and compare its use to immediate emergency surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Consecutive patients with obstructing colorectal cancers, confirmed on water-soluble contrast enema or computed tomography (CT) scan
- Consented patients
Key exclusion criteria (4 listed)
- Patients with peritonitis that required immediate surgical intervention
- Patients with distal rectal cancers that are not suitable for stenting
- Moribund patients, unfit for surgery otherwise
- Pregnancy
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 |
|---|---|---|
| Endoscopic stenting followed by elective laparoscopic resection | Procedure or surgery | – |
Primary outcome
The success rate of relieving obstruction after stent insertion
The stoma rate in the two groups of patients
2 secondary outcomes
Morbidity and mortality rates in the two groups
Hospital stay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2007.
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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.
James YW Lau, MD, FRCS(Edin) principal investigator
Chinese University of Hong Kong
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 Endoscopic stenting followed by elective laparoscopic resection in people with Colorectal Cancer and Bowel Obstruction, 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 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 7 Aug 2007. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James YW Lau, MD, FRCS(Edin) ((852)26322627, laujyw@netvigator.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate of relieving obstruction after stent insertion. 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?
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 7 Aug 2007.