Stent OcclusionNCT04111042
Long-term Outcomes of Colonic Stent as a "Bridge to Surgery" for Malignant Large-bowel Obstruction
An observational study of Stent Occlusion and Long-term Oncologic Results, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
Study of long-term outcomes of colonic stent as a "bridge to surgery" for malignant large-bowel obstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stent Occlusion, Long-term Oncologic Results
- What is being tested?
- stenting
- Type of treatment
- Medical device
- How many people
- 117 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2016to Aug 2019
- 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: : patient demographics, physiological status according to the American Society of Anesthesiologist (ASA) score, tumor characteristics and localization, type of surgery, surgical team, stoma formation rate, perioperative morbidity and mortality, tumor stage according to the International Union Against Cancer (UICC)-TNM Classification of Malignant Tumors published by the National Comprehensive Cancer Network (7th edition), administration of adjuvant treatment, local and distant disease recurrence based on CT imaging (and histological tissue if possible), disease-free survival and overall survival.
Who may be able to join
- Patients aged over 18 years diagnosed with complete malignant colonic obstruction confirmed by CT.
- Elective surgery.
- Location in transverse, left or sigmoid colon.
- Patients who signed the informed consent documentation and agreed to undergo the procedure.
Who cannot join
- Benign pathology and palliative treatment.
- Unresectable lesion (intraoperative), severe ischemia or cecal perforation, fecal or advanced purulent peritonitis, emergency surgery.
- Previous chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Study of long-term outcomes of colonic stent as a "bridge to surgery" for malignant large-bowel obstruction.
Read the detailed description
Prospective observational with retrospective analisis study of patients with left-sided malignant colonic obstruction undergoing stenting between April 2006 and April 2018 in Parc Tauli University Hospital. We assessed all patients with intent-to-treat and per protocol analyses in postoperative and long-term follow-up variables.
- Conditions
- Stent Occlusion, Long-term Oncologic Results
- Being tested
- stenting
- Keywords
- Malignant colonic obstruction, self-expandable metallic stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stentingDevice
stenting procedure in patients diagnosed malignant large bowel occlusion
What is being measured
The primary outcome is the main question the study is designed to answer.
long-term outcomes
survival rates
Measured: 2 years
Secondary outcomes (1)
anastomotic leak
surgery
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study startApr 2016
- Primary completionApr 2016
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stent OcclusionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Xavier Serra-Aracil, Anna Pallisera-Lloveras
- Responsible party
- Principal investigator, Laura Mora-Lopez, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111042
- Sponsor's protocol ID
- TAULI-STENT
- Status last verified
- Sep 2019
- First submitted
- 29 Sep 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There's no sharing plan because the study has finished the recruited time
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes of Colonic Stent as a "Bridge to Surgery" for Malignant Large-bowel Obstruction
- ClinicalTrials.gov ID
- NCT04111042
- Acronym / sponsor ID
- TAULI-STENT
- Conditions
- Stent Occlusion, Long-term Oncologic Results
- Keywords
- Malignant colonic obstruction, self-expandable metallic stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Xavier Serra-Aracil, Anna Pallisera-Lloveras
- Study start
- Apr 2016 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 1 Oct 2019 (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.
Study of long-term outcomes of colonic stent as a "bridge to surgery" for malignant large-bowel obstruction.
Detailed description
Prospective observational with retrospective analisis study of patients with left-sided malignant colonic obstruction undergoing stenting between April 2006 and April 2018 in Parc Tauli University Hospital. We assessed all patients with intent-to-treat and per protocol analyses in postoperative and long-term follow-up variables.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- : patient demographics, physiological status according to the American Society of Anesthesiologist (ASA) score, tumor characteristics and localization, type of surgery, surgical team, stoma formation rate, perioperative morbidity and mortality, tumor stage according to the International Union Against Cancer (UICC)-TNM Classification of Malignant Tumors published by the National Comprehensive Cancer Network (7th edition), administration of adjuvant treatment, local and distant disease recurrence based on CT imaging (and histological tissue if possible), disease-free survival and overall survival.
Key inclusion criteria (4 listed)
- Patients aged over 18 years diagnosed with complete malignant colonic obstruction confirmed by CT.
- Elective surgery.
- Location in transverse, left or sigmoid colon.
- Patients who signed the informed consent documentation and agreed to undergo the procedure.
Key exclusion criteria (3 listed)
- Benign pathology and palliative treatment.
- Unresectable lesion (intraoperative), severe ischemia or cecal perforation, fecal or advanced purulent peritonitis, emergency surgery.
- Previous chemotherapy.
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 |
|---|---|---|
| stentingstenting procedure in patients diagnosed malignant large bowel occlusion | Device | – |
Primary outcome
long-term outcomes
Time frame: 2 years
survival rates
1 secondary outcome
anastomotic leak
Time frame: 30 days
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 1 Oct 2019.
- Individual participant dataSharing planned: No. There's no sharing plan because the study has finished the recruited time
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stent Occlusion and Long-term Oncologic Results, run by Corporacion Parc Tauli at 1 site in Spain.
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 4 inclusion and 3 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 1 Oct 2019. 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 Spain. 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?
long-term outcomes (time frame: 2 years). 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 1 Oct 2019.