Comparison of Efficacy Between a Newly Designed Covered Stent and Uncovered Stent for Malignant Colorectal Obstruction

Yonsei University

Status: Unknown

Conditions: Colorectal Cancer

Treatments: Procedure: self-expandable metal stent insertion(covered stent); Procedure: self-expandable metal stent insertion(uncovered stent)

Study type: Interventional

Funder types: Other

Identifiers

NCT02640781

1-2015-0046

Details and patient eligibility

About

Acute colorectal obstruction has been reported to occur in 7 - 29% of all colorectal malignancies, but emergent surgical decompression is associated with high morbidity and mortality rates. Recently, self-expandable metal stents(SEMS) have been suggested as an alternative to surgery and effectively decompress the colonic obstruction and allow for bowel preparation and elective surgery. Theoretically, SEMSs are classified into uncovered stents and covered stents. Covered stents have the advantage of less frequent stent occlusion by tumor in-growth and the disadvantage of a high risk of stent migration, whereas uncovered stents are associated with less stent migration, although they appear to be more prone to tumor ingrowth. To overcome the drawbacks of conventional stents, a double-layered combination covered stent was developed. In the present study, the investigators evaluated the efficacy and safety of the newly designed covered stent by comparing it with the uncovered stent in patients with malignant colorectal obstruction.

Enrollment: 70 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 20~85-year-old patients with malignant colorectal obstruction either by primary CRC or extracolonic malignancy
• Patients with clinical obstructive symptoms confirmed by CT or colonoscopy

Exclusion criteria

• Patients with evidence of bowel perforation or peritonitis
• Cause of obstruction other than malignancy (bowel adhesion or benign stricture)
• Multiple stricture
• Lower rectal cancer obstruction (AV <5cm)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

covered stent

Experimental group

Description:

newly designed covered stent group

Treatment:

Procedure: self-expandable metal stent insertion(covered stent)

uncovered stent

Active Comparator group

Description:

currently used uncovered stent group

Treatment:

Procedure: self-expandable metal stent insertion(uncovered stent)