Colorectal CarcinomaNCT04494919
Novel Stent Placement Technique for Intestinal Stenosis Assisted by an Ultrafine Endoscope
An observational study of Colorectal Carcinoma, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
Colorectal cancer is the third most common cancer worldwide and results in 8-25% acute malignant bowel obstruction. Since Dohmoto et al. first applied and reported the self-expanding metal stents (SEMS) in the treatment of colorectal stenosis, they have been widely used not only as an alternative treatment as a bridge… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- Ultrafine Endoscope
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 30 Jun 2020
- 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: patients with colorectal stricture underwent novel intestinal stent implantation methods assised by ultrafine endoscope.
Who may be able to join
- Age ≥ 18 years old
- Patients with colorectal cancer stenosis
- Patients with intestinal stent implantation in digital subtraction angiography room
Who cannot join
- Patients undergoing conventional intestinal stent implantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two Different Novel Stent Placement Technique for Intestinal Stenosis Assisted by an Ultrafine Endoscope
Colorectal cancer is the third most common cancer worldwide and results in 8-25% acute malignant bowel obstruction. Since Dohmoto et al. first applied and reported the self-expanding metal stents (SEMS) in the treatment of colorectal stenosis, they have been widely used not only as an alternative treatment as a bridge to surgery (BTS), but also as a mean of palliative option for stenosing lumen in clinical practice. Numerous publications have reported that the stent placement technique showed 75% to 100% technical success rates and 84% to 100% clinical success rates. However, it is sometimes difficult to place due to the distorted anatomy or acute angulations in patients and other conditions with poor endoscopic visualization with the normal colonoscope. The aims of this study were to present our results with two novel SEMS implantation techniques.
- Conditions
- Colorectal Carcinoma
- Being tested
- Ultrafine Endoscope
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrafine EndoscopeDevice
The reversal of the normal colonoscope (CV-260SL; Olympus, Tokyo, Japan) along the guidewire to replace the UFE (GIF-XP260NS; Olympus, Tokyo, Japan).
| Study group | Role | What they receive |
|---|---|---|
| Ultrafine Endoscope Assisted | The self-expanding metal stent (SEMS) implantation was conducted using an ultrafine endoscope (UFE) (GIF-XP260NS; Olympus, Tokyo, Japan). The UFE researched the stricture, and a guidewire was inserted into the endoscopic working channel. The guidewire was left. And the endoscope was withdrawn. The normal colonoscope was exchanged under the reverse guidance of the guidewire. Finally, a metal, uncovered SEMS was placed along the guidewire. Receives: Device: Ultrafine Endoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
The technical success rate
the ratio between the patients with correctly placed SEMS and those scheduled for SEMS implantation.
Measured: 1 hour
Secondary outcomes (2)
The clinical success rate
the ratio between the patients with regressive signs and symptoms of obstruction (within 24 h) and those succeeded for SEMS implantation.
Measured: 24 hours
The adverse events rate
the ratio between the patients with adverse events (like perforation, bleeding, and reobstruction) and those succeeded for SEMS implantation.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start1 Jun 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494919
- Sponsor's protocol ID
- UFE-1.0
- Status last verified
- Jul 2020
- First submitted
- 28 Jul 2020
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Different Novel Stent Placement Technique for Intestinal Stenosis Assisted by an Ultrafine Endoscope
- ClinicalTrials.gov ID
- NCT04494919
- Acronym / sponsor ID
- UFE-1.0
- Conditions
- Colorectal Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 31 Jul 2020 (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.
Colorectal cancer is the third most common cancer worldwide and results in 8-25% acute malignant bowel obstruction. Since Dohmoto et al. first applied and reported the self-expanding metal stents (SEMS) in the treatment of colorectal stenosis, they have been widely used not only as an alternative treatment as a bridge to surgery (BTS), but also as a mean of palliative option for stenosing lumen in clinical practice. Numerous publications have reported that the stent placement technique showed 75% to 100% technical success rates and 84% to 100% clinical success rates. However, it is sometimes difficult to place due to the distorted anatomy or acute angulations in patients and other conditions with poor endoscopic visualization with the normal colonoscope. The aims of this study were to present our results with two novel SEMS implantation techniques.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrafine Endoscope Assisted | – | Device: Ultrafine EndoscopeThe self-expanding metal stent (SEMS) implantation was conducted using an ultrafine endoscope (UFE) (GIF-XP260NS; Olympus, Tokyo, Japan). The UFE researched the stricture, and a guidewire was inserted into the endoscopic working channel. The guidewire was left. And the endoscope was withdrawn. The normal colonoscope was exchanged under the reverse guidance of the guidewire. Finally, a metal, uncovered SEMS was placed along the guidewire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with colorectal stricture underwent novel intestinal stent implantation methods assised by ultrafine endoscope.
Key inclusion criteria (3 listed)
- Age ≥ 18 years old
- Patients with colorectal cancer stenosis
- Patients with intestinal stent implantation in digital subtraction angiography room
Key exclusion criteria (1 listed)
- Patients undergoing conventional intestinal stent implantation
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 |
|---|---|---|
| Ultrafine EndoscopeThe reversal of the normal colonoscope (CV-260SL; Olympus, Tokyo, Japan) along the guidewire to replace the UFE (GIF-XP260NS; Olympus, Tokyo, Japan). | Device | Ultrafine Endoscope Assisted |
Primary outcome
The technical success rate
Time frame: 1 hour
the ratio between the patients with correctly placed SEMS and those scheduled for SEMS implantation.
2 secondary outcomes
The clinical success rate
Time frame: 24 hours
The adverse events rate
Time frame: 2 year
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 4 Aug 2020.
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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 Colorectal Carcinoma, run by Ningbo No. 1 Hospital 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 3 inclusion and 1 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 4 Aug 2020. 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.
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?
The technical success rate (time frame: 1 hour). 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 4 Aug 2020.