Novel Stent Placement Technique for Intestinal Stenosis Assisted by an Ultrafine Endoscope
July 31, 2020 updated by: Ningbo No. 1 Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
18
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
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Ningbo, Zhejiang, China, 315000
- Ningbo First Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with colorectal stricture underwent novel intestinal stent implantation methods assised by ultrafine endoscope.
Description
Inclusion Criteria:
- Age ≥ 18 years old
- Patients with colorectal cancer stenosis
- Patients with intestinal stent implantation in digital subtraction angiography room
Exclusion Criteria:
- Patients undergoing conventional intestinal stent implantation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
The reversal of the normal colonoscope (CV-260SL; Olympus, Tokyo, Japan) along the guidewire to replace the UFE (GIF-XP260NS; Olympus, Tokyo, Japan).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The technical success rate
Time Frame: 1 hour
|
the ratio between the patients with correctly placed SEMS and those scheduled for SEMS implantation.
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The clinical success rate
Time Frame: 24 hours
|
the ratio between the patients with regressive signs and symptoms of obstruction (within 24 h) and those succeeded for SEMS implantation.
|
24 hours
|
|
The adverse events rate
Time Frame: 2 year
|
the ratio between the patients with adverse events (like perforation, bleeding, and reobstruction) and those succeeded for SEMS implantation.
|
2 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2018
Primary Completion (Actual)
June 30, 2020
Study Completion (Actual)
June 30, 2020
Study Registration Dates
First Submitted
July 28, 2020
First Submitted That Met QC Criteria
July 28, 2020
First Posted (Actual)
July 31, 2020
Study Record Updates
Last Update Posted (Actual)
August 4, 2020
Last Update Submitted That Met QC Criteria
July 31, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UFE-1.0
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.