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

Not Applicable

• Conditions: Colorectal Cancer
• Interventions: Procedure: self-expandable metal stent insertion(uncovered stent); Procedure: self-expandable metal stent insertion(covered stent)

• Registration Number: NCT02640781
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-10
• Study First Submitted QC: 2015-12-22
• Study First Posted: 2015-12-29
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-27
• Primary Completion: 2019-08
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
uncovered stent	self-expandable metal stent insertion(uncovered stent)	currently used uncovered stent group
covered stent	self-expandable metal stent insertion(covered stent)	newly designed covered stent group

Primary Outcome Measures

Name	Time	Method
Duration of stent patency between stent insertion and recurrence of obstructive symptoms	2 years after the procedure	Time between stent insertion and recurrence of obstructive symptoms caused by tumor ingrowth, tumor overgrowth, or stent migration after stent placement

Secondary Outcome Measures

Name	Time	Method
Number of patients with clinical success	2 years after the procedure	Clinical success: Relief from obstructive symptoms as a result of sufficient improvement in stool passage without additional need for endoscopic or surgical re-intervention within 48 hours
Number of patients with complications	2 years after the procedure	Complications: stent obstruction, migration, perforation, bleeding, tenesmus, anal pain
Number of patients with technical success	2 years after the procedure	Technical success: Adequate deployment across the entire length of the malignant strictures and proper stent expansion

Trial Locations

Locations (1)

Department of Internal Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of