Novel Stent Placement Technique for Intestinal Stenosis Assisted by an Ultrafine Endoscope
Two Different Novel Stent Placement Technique for Intestinal Stenosis Assisted by an Ultrafine Endoscope
1 other identifier
observational
18
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedFirst Submitted
Initial submission to the registry
July 28, 2020
CompletedFirst Posted
Study publicly available on registry
July 31, 2020
CompletedAugust 4, 2020
July 1, 2020
2.1 years
July 28, 2020
July 31, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
The technical success rate
the ratio between the patients with correctly placed SEMS and those scheduled for SEMS implantation.
1 hour
Secondary Outcomes (2)
The clinical success rate
24 hours
The adverse events rate
2 year
Study Arms (1)
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.
Interventions
The reversal of the normal colonoscope (CV-260SL; Olympus, Tokyo, Japan) along the guidewire to replace the UFE (GIF-XP260NS; Olympus, Tokyo, Japan).
Eligibility Criteria
patients with colorectal stricture underwent novel intestinal stent implantation methods assised by ultrafine endoscope.
You may qualify if:
- Age ≥ 18 years old
- Patients with colorectal cancer stenosis
- Patients with intestinal stent implantation in digital subtraction angiography room
You may not qualify if:
- Patients undergoing conventional intestinal stent implantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ningbo first hospital
Ningbo, Zhejiang, 315000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2020
First Posted
July 31, 2020
Study Start
June 1, 2018
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
August 4, 2020
Record last verified: 2020-07