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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
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.
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.
Department of Internal Medicine, Yonsei University College of Medicine
Seoul, South Korea
RECRUITINGDuration 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
Time frame: 2 years after the procedure
Number of patients with technical success
Technical success: Adequate deployment across the entire length of the malignant strictures and proper stent expansion
Time frame: 2 years after the procedure
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
Time frame: 2 years after the procedure
Number of patients with complications
Complications: stent obstruction, migration, perforation, bleeding, tenesmus, anal pain
Time frame: 2 years after the procedure
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