Colonic Stenting Versus Emergency Surgery for Management of Acute Left-Sided Malignant Colonic Obstruction: A Multicenter Randomized Trial (Stent-In 2 Study)

Abstract

Patients with acute left-sided malignant colonic obstruction are usually treated with emergency surgery. These operations have a high morbidity and mortality. Stent placement as bridge to elective surgery has been suggested to decrease morbidity, mortality and the number of colostomies. No adequately powered randomized controlled trials have been reported in the literature. The objective of this study is to compare the effectiveness and costs of these two treatment algorithms. Methods: This is a prospective multicenter (25 centers) randomized controlled trial. Patients with acute left-sided malignant colonic obstruction are randomly allocated to emergency surgery or colonic stenting as bridge to surgery. Inclusion criteria are ileus less than 1 week with malignant obstruction on imaging, exclusion criteria are serious complications demanding urgent surgery; ASA IV or V; distal tumor margin less than 10 cm from the anal verge. Effectiveness is evaluated in terms of quality of life, morbidity and mortality. Quality of life is measured with standardized questionnaires (EORTC QLQ-C30, EORTC QLQ-CR38, EQ-5D and EQ-VAS). The total costs of treatment are evaluated by counting volumes and calculating unit prices. Patients are followed for a period of 6 months. Including 120 patients on a 1: 1 basis will have 80% power to detect an effect size of 0.5 on the EORTC QLQ-C30 global health scale, using a two group t-test with a 0.05 two-sided significance level. After inclusion of 60 patients an interim analysis will be performed. Results: From 04/2007 until 10/2008 47 patients (24 men, mean age 69 years) have been enrolled in 17 participating centers. 24 Patients have been assigned to emergency surgery and 23 to stenting. All patients randomized for emergency surgery were treated accordingly. Of the patients randomized to stenting 7 did not receive an enteral stent: 4 appeared to have a diverticular stenosis, 1 patient had a tumor fistula to the small bowel and in 2 patients there was a technical failure. Pathology confirmed malignancy in 22 of the 24 patients assigned to emergency surgery and in 18 of the 23 patients allocated to enteral stenting. With the current inclusion rate, the interim analysis is expected in spring 2009 and the inclusion should be completed in 2011. Conclusion: Endoscopic colonic stent placement as bridge to elective surgery seems to be an attractive alternative to emergency surgery in patients with acute left-sided malignant colonic obstruction. Evidence for its wide-spread application is not yet available. Its effectiveness and costs are currently investigated in a multicenter randomized trial in the Netherlands.