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

Colorectal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04494919
• Other study ID #: UFE-1.0
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: Ningbo No. 1 Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Carcinoma
• Colorectal Neoplasms

Intervention

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).

Locations

Country	Name	City	State
China	Ningbo first hospital	Ningbo	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Ningbo No. 1 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The technical success rate	the ratio between the patients with correctly placed SEMS and those scheduled for SEMS implantation.	1 hour
Secondary	The clinical success rate	the ratio between the patients with regressive signs and symptoms of obstruction (within 24 h) and those succeeded for SEMS implantation.	24 hours
Secondary	The adverse events rate	the ratio between the patients with adverse events (like perforation, bleeding, and reobstruction) and those succeeded for SEMS implantation.	2 year