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

Completed

• Conditions: Colorectal Carcinoma
• Interventions: Device: Ultrafine Endoscope

• Registration Number: NCT04494919
• Lead Sponsor: Ningbo No. 1 Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2020-07
• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-31
• Last Update Submitted: 2020-07-31
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ultrafine Endoscope Assisted	Ultrafine Endoscope	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 And the endoscope was withdrawn.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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Ningbo first hospital; 🇨🇳 Ningbo, Zhejiang, China