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

  • China
    • Zhejiang
      • 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.
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).

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

Ningbo No. 1 Hospital

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.

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