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

Sponsor

Ningbo No. 1 Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04494919

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Carcinoma	Device: Ultrafine Endoscope

Study Design

Study Type:

Observational

Actual Enrollment :

18 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2018

Actual Primary Completion Date :

Jun 30, 2020

Actual Study Completion Date :

Jun 30, 2020

Arms and Interventions

Arm	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 And the endoscope was withdrawn.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).

Arm

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).

Outcome Measures

Primary Outcome Measures

The technical success rate [1 hour]
the ratio between the patients with correctly placed SEMS and those scheduled for SEMS implantation.

Secondary Outcome Measures

The clinical success rate [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 [2 year]
the ratio between the patients with adverse events (like perforation, bleeding, and reobstruction) and those succeeded for SEMS implantation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ningbo first hospital	Ningbo	Zhejiang	China	315000

Sponsors and Collaborators

Ningbo No. 1 Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ningbo No. 1 Hospital

ClinicalTrials.gov Identifier:

NCT04494919

Other Study ID Numbers:

UFE-1.0

First Posted:

Jul 31, 2020

Last Update Posted:

Aug 4, 2020

Last Verified:

Jul 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of Aug 4, 2020