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

NCT ID: NCT02640781

Last Updated: 2019-03-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2019-08-31

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

covered stent

newly designed covered stent group

Group Type: EXPERIMENTAL

self-expandable metal stent insertion(covered stent)

Intervention Type: PROCEDURE

Stent insertion was performed by experienced endoscopists under fluoroscopy and by using through-the-scope methods. After the obstructing tumor was identified by endoscopy, a guidewire was introduced through the stricture under endoscopic and fluoroscopic controls. Then, the self-expandable colorectal covered stent delivery catheter was advanced through the working channel of the endoscope over the guidewire until the stent was positioned across the stricture. Upon releasing the stent delivery catheter, stent deployment was initiated proximally and progressed distally. Simple abdominal radiography was performed during and after the procedures to confirm proper stent placement and expansion.

uncovered stent

currently used uncovered stent group

Group Type: ACTIVE_COMPARATOR

self-expandable metal stent insertion(uncovered stent)

Intervention Type: PROCEDURE

Stent insertion was performed by experienced endoscopists under fluoroscopy and by using through-the-scope methods. After the obstructing tumor was identified by endoscopy, a guidewire was introduced through the stricture under endoscopic and fluoroscopic controls. Then, the self-expandable colorectal stent delivery uncovered catheter was advanced through the working channel of the endoscope over the guidewire until the stent was positioned across the stricture. Upon releasing the stent delivery catheter, stent deployment was initiated proximally and progressed distally. Simple abdominal radiography was performed during and after the procedures to confirm proper stent placement and expansion.

Interventions

self-expandable metal stent insertion(covered stent)

Stent insertion was performed by experienced endoscopists under fluoroscopy and by using through-the-scope methods. After the obstructing tumor was identified by endoscopy, a guidewire was introduced through the stricture under endoscopic and fluoroscopic controls. Then, the self-expandable colorectal covered stent delivery catheter was advanced through the working channel of the endoscope over the guidewire until the stent was positioned across the stricture. Upon releasing the stent delivery catheter, stent deployment was initiated proximally and progressed distally. Simple abdominal radiography was performed during and after the procedures to confirm proper stent placement and expansion.

Intervention Type: PROCEDURE

self-expandable metal stent insertion(uncovered stent)

Stent insertion was performed by experienced endoscopists under fluoroscopy and by using through-the-scope methods. After the obstructing tumor was identified by endoscopy, a guidewire was introduced through the stricture under endoscopic and fluoroscopic controls. Then, the self-expandable colorectal stent delivery uncovered catheter was advanced through the working channel of the endoscope over the guidewire until the stent was positioned across the stricture. Upon releasing the stent delivery catheter, stent deployment was initiated proximally and progressed distally. Simple abdominal radiography was performed during and after the procedures to confirm proper stent placement and expansion.

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Internal Medicine, Yonsei University College of Medicine

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Tae-Il Kim, MD, Ph.D

Role: CONTACT

taeilkim@yuhs.ac

82-2-2228-1965

Facility Contacts

TAE IL KIM, MD

Role: primary

taeilkim@yuhs.ac

82-2-2228-1965

References

Park SJ, Park Y, Lee HJ, Park JJ, Cheon JH, Kim WH, Kim TI. Newly designed flared-end covered versus uncovered self-expandable metallic stents for palliation of malignant colorectal obstruction: a randomized, prospective study. Intest Res. 2025 Apr;23(2):202-212. doi: 10.5217/ir.2024.00135. Epub 2025 Feb 24.

Reference Type: DERIVED

PMID: 39988445 (View on PubMed)

Other Identifiers

1-2015-0046

Identifier Type: -

Identifier Source: org_study_id