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

NCT02640781 | Unknown

• 1 other identifier: 1-2015-0046
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Duration of stent patency between stent insertion and recurrence of obstructive symptoms

  Time between stent insertion and recurrence of obstructive symptoms caused by tumor ingrowth, tumor overgrowth, or stent migration after stent placement

  2 years after the procedure

Secondary Outcomes (3)

• Number of patients with technical success

  2 years after the procedure

• Number of patients with clinical success

  2 years after the procedure

• Number of patients with complications

  2 years after the procedure

Study Arms (2)

covered stent

EXPERIMENTAL

newly designed covered stent group

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

uncovered stent

ACTIVE COMPARATOR

currently used uncovered stent group

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

Interventions

self-expandable metal stent insertion(covered stent) 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.

covered stent

self-expandable metal stent insertion(uncovered stent) 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.

uncovered stent

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Internal Medicine, Yonsei University College of Medicine

Seoul, 120-752, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 39988445 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Tae-Il Kim, MD, Ph.D

CONTACT

82-2-2228-1965; taeilkim@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 29, 2015
• Study Start: December 1, 2015
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: March 27, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)