Gastrointestinal NeoplasmsNCT00422409
Endoscopic Stenting of Gastrointestinal Cancer
A study testing Endoscopic stenting in people with Gastrointestinal Neoplasms and Biliary Tract Neoplasms, run by Ullevaal University Hospital at 7 sites in Norway.
Trial summary
Obstruction of the digestive tract is a frequent cause of morbidity in patients with gastrointestinal cancer.Palliative endoscopic treatment with self- expanding metal stents(SEMS)is an alternative to palliative surgery and other palliative treatment options.The method has expanded to include patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Neoplasms, Biliary Tract Neoplasms
- What is being tested?
- Endoscopic stenting
- Type of treatment
- Surgery or procedure
- How many people
- 270 participants
- Where
- 7 sitesNorway
- Study dates
- Oct 2006to Apr 2010
- 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
- Palliative SEMS treatment for malignant GI-obstruction in esophagus,gastroduodenal region, biliary tractus or colon
- SEMS treatment of acute malignant colon obstruction as a bridge to surgery
Who cannot join
- Not able to sign informed consent
- SEMS placement in other location last 4 days
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Norway7 sites
Sentral Hospital Buskerud
Drammen
Sentral Hospital Østfold
Fredrikstad
Sykehuset Innlandet Gjøvik
Gjøvik
Sykehuset Innlandet Lillehammer
Lillehammer
Ullevaal University Hospital
Oslo, 0407
AHUS University Hospital
Oslo
Aker University Hospital
Oslo
About this study
Official title: Palliative Endoscopic Treatment of Malignant GI-strictures With Self Expanding Metal Stents(SEMS)-a Prospective Multicenter Study
Obstruction of the digestive tract is a frequent cause of morbidity in patients with gastrointestinal cancer.Palliative endoscopic treatment with self- expanding metal stents(SEMS)is an alternative to palliative surgery and other palliative treatment options.The method has expanded to include patients with malignancies in the esophagus,gastroduodenal region, biliary tractus and colon. Numerous retrospective studies have reported treatment with SEMS to be safe and effective. Prospective studies,and especially studies regarding Quality of Life improvement are needed.
PURPOSE:
The purpose of this trial is to prospectively study the use and effect of selfexpanding metal stents(SEMS)in a defined population i Norway, especially Quality of Life changes.
Read the detailed description
The study is divided into four projects:
- Establish a central register over all patients with malignant GI-obstruction who are treated with SEMS in the Eastern health region in Norway .Treatment incidence, methods used, treatment effect,complications related to the procedure,Need for reinterventions, hospitalisations and survival will be studied.
- Quality of life(QoL) studies will be performed before and 14 days after treatment.The EORTC QLQ C30 and EORTCs organospecific modules will be used.
- Gastric emptying before/after stent will be studied.
- Evaluate SEMS treatment of acute colon obstruction, as a permanent palliative treatment or as a "bridge to surgery"
- Being tested
- Endoscopic stenting
- Keywords
- SEMS
- Medical subject headings
- Gastrointestinal Neoplasms, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic stentingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Change/improvement i Quality of life
Secondary outcomes (5)
Need for reintervention
Change/improvement in gastric emptying
Rehospitalisations
Complications
Death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2007 (estimated)
- Study startOct 2006
- Primary completionApr 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal NeoplasmsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Truls Hauge, MD,PhD, Study director, Ullevaal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422409
- Sponsor's protocol ID
- 672
- Status last verified
- Apr 2007
- First submitted
- 16 Jan 2007
- Last updated
- 6 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Endoscopic Treatment of Malignant GI-strictures With Self Expanding Metal Stents(SEMS)-a Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT00422409
- Acronym / sponsor ID
- 672
- Keywords
- SEMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 17 Jan 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.
Obstruction of the digestive tract is a frequent cause of morbidity in patients with gastrointestinal cancer.Palliative endoscopic treatment with self- expanding metal stents(SEMS)is an alternative to palliative surgery and other palliative treatment options.The method has expanded to include patients with malignancies in the esophagus,gastroduodenal region, biliary tractus and colon. Numerous retrospective studies have reported treatment with SEMS to be safe and effective. Prospective studies,and especially studies regarding Quality of Life improvement are needed.
PURPOSE:
The purpose of this trial is to prospectively study the use and effect of selfexpanding metal stents(SEMS)in a defined population i Norway, especially Quality of Life changes.
Detailed description
The study is divided into four projects:
- Establish a central register over all patients with malignant GI-obstruction who are treated with SEMS in the Eastern health region in Norway .Treatment incidence, methods used, treatment effect,complications related to the procedure,Need for reinterventions, hospitalisations and survival will be studied.
- Quality of life(QoL) studies will be performed before and 14 days after treatment.The EORTC QLQ C30 and EORTCs organospecific modules will be used.
- Gastric emptying before/after stent will be studied.
- Evaluate SEMS treatment of acute colon obstruction, as a permanent palliative treatment or as a "bridge to surgery"
Study design
- Primary purpose
- Treatment
- Allocation
- Non-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)
- Palliative SEMS treatment for malignant GI-obstruction in esophagus,gastroduodenal region, biliary tractus or colon
- SEMS treatment of acute malignant colon obstruction as a bridge to surgery
Key exclusion criteria (2 listed)
- Not able to sign informed consent
- SEMS placement in other location last 4 days
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 | Procedure or surgery | – |
Primary outcome
Change/improvement i Quality of life
5 secondary outcomes
Need for reintervention
Change/improvement in gastric emptying
Rehospitalisations
Complications
Death
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 6 Jul 2011.
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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.
Truls Hauge, MD,PhD study director
Ullevaal University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic stenting in people with Gastrointestinal Neoplasms and Biliary Tract Neoplasms, run by Ullevaal University Hospital at 7 sites in Norway.
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 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 6 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Norway. 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?
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?
Change/improvement i Quality of life. 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 6 Jul 2011.