A Japanese prospective multicenter study of self-expandable metal stent placement for malignant colorectal obstruction: short-term safety and efficacy within 7 days of stent procedure in 513 cases.

BACKGROUND

Endoscopic self-expandable metal stent placement has been used as an alternative to surgery for malignant colorectal obstruction; however, factors affecting its clinical outcome are unclear.

OBJECTIVE

To clarify the short-term safety and efficacy of endoscopic self-expandable metal stent placement for malignant colorectal obstruction and to identify factors associated with its clinical and technical failure.

DESIGN

Prospective clinical cohort study.

SETTING

Fourteen academic centers and 32 community hospitals.

PATIENTS

A total of 513 consecutive patients with malignant colorectal obstruction.

INTERVENTION

Endoscopic self-expandable metal stent placement, sharing of stent placement methods among participating facilities.

MAIN OUTCOME MEASUREMENTS

The primary endpoint was clinical success, defined as symptom and radiological finding resolution within 24 hours. Secondary endpoints were technical success and adverse events. The follow-up period was 7 days.

RESULTS

The clinical and technical success rates were 95.5% and 97.9%, respectively. Major adverse events included perforation (2.1%), stent migration (1.0%), and stent occlusion (0.8%). The main causes of perforation were the procedure itself (0.8%) and comorbidities (obstructive colitis and impending perforation) not apparent before stent placement (0.6%). Extrinsic tumor origin was independently associated with the clinical failure after stent placement (odds ratio 4.23; 95% confidence interval, 1.21-14.79; P = .02). Stricture marking trended toward a negative association with technical failure (P = .09).

LIMITATIONS

Noncomparative study.

CONCLUSION

Strict inclusion criteria and stricture marking may improve the technical and clinical success of stent placement.