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

Colorectal Cancer Clinical Trial

Official title:

Comparison of Efficacy Between a Newly Designed Covered Stent and Uncovered Stent for Malignant Colorectal Obstruction: a Prospective, Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02640781
• Other study ID #: 1-2015-0046
• Status: Recruiting
• Phase: N/A
• Start date: December 2015
• Est. completion date: August 2019

Study information

• Verified date: March 2019
• Source: Yonsei University
• Contact: Tae-Il Kim, MD, Ph.D
• Phone: 82-2-2228-1965
• Email: taeilkim[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Internal Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of patients with technical success	Technical success: Adequate deployment across the entire length of the malignant strictures and proper stent expansion	2 years after the procedure
Secondary	Number of patients with clinical success	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	2 years after the procedure
Secondary	Number of patients with complications	Complications: stent obstruction, migration, perforation, bleeding, tenesmus, anal pain	2 years after the procedure