Colorectal Cancer
Conditions
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.
Interventions
PROCEDUREself-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.
PROCEDUREself-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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
South Korea
Contacts
Primary ContactTae-Il Kim, MD, Ph.D
Outcome results
None listed