Novel Stent Placement Technique for Intestinal Stenosis Assisted by an Ultrafine Endoscope

Overview

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.

Full Title of Study: “Two Different Novel Stent Placement Technique for Intestinal Stenosis Assisted by an Ultrafine Endoscope”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: June 30, 2020

Interventions

  • Device: Ultrafine Endoscope
    • The reversal of the normal colonoscope (CV-260SL; Olympus, Tokyo, Japan) along the guidewire to replace the UFE (GIF-XP260NS; Olympus, Tokyo, Japan).

Arms, Groups and Cohorts

  • 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 And the endoscope was withdrawn.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.

Clinical Trial Outcome Measures

Primary Measures

  • The technical success rate
    • Time Frame: 1 hour
    • the ratio between the patients with correctly placed SEMS and those scheduled for SEMS implantation.

Secondary Measures

  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ningbo No. 1 Hospital
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.