Covered versus uncovered endoluminal stenting in the acute management of obstructing colorectal cancer in the palliative setting: randomized clinical trial (CReST2).

backgroundAround 15% of people with colon cancer present with an obstruction. Stenting is appropriate for patients unfit for surgery and/or those with advanced cancer. Patients are living longer with advanced colon cancer; stent design (covered versus uncovered) may influence stent re-intervention and quality of life (QoL).

methodsCReST2 is a phase III multicentre RCT. Patients were randomized 1 : 1 to receive either a covered or uncovered stent. Patients and all medical personnel except the person placing the stent were blinded to allocation. Treatment allocation was via a central randomization service, minimized for: age (≤70 years, >70 years), WHO performance status, tumour site, and indication for palliation. Co-primary endpoints were stent patency up to 6 months after randomization and QoL at 3 months (30 days for patients who died before 3 months) from randomization measured using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 global health score. Secondary endpoints were stenting success rate, rates of short-term (30 days), intermediate-term (1-3 months), and long-term (3-6 months) stent-related complications, stent-related complication rates of patients undergoing chemotherapy within 6 months after randomization, cumulative frequency of stoma formation, survival at 6 months, and overall survival.

resultsA total of 377 patients were randomised across 28 sites, in whom stenting was unsuccessful in 47 (12.5%) patients (27 of 188: 14.4% covered and 20 of 186: 10.7% uncovered stents). Stent patency at 6 months in stented patients was 117 of 161 (72.7%, covered) and 136 of 166 (81.9%, uncovered) (adjusted HR 1.48, 97.5% confidence interval (c.i.): 0.86-2.54). In this stented population, 216 patients (66.1%) contributed to QoL assessment at 3 months with mean(s.d.) QLQ-C30 global health scores of 54.1(23.9) and 51.6(25.4) in the covered and uncovered groups respectively (adjusted mean difference 1.63, 97.5% c.i. -5.85-9.11). The total numbers of patients experiencing at least one complication in the first 6 months after randomization were 42 of 161 (26.1%) for covered stents and 29 of 166 (17.5%) for uncovered stents. Stent migration was the most common complication and was higher in the covered group. In the covered group and the uncovered group, 44 of 161 (27.3%) and 40 of 166 (24.1%) patients respectively received chemotherapy up to 6 months after randomization. There was a low risk of late perforation associated with both types of stent.

conclusionThere appears to be greater prolonged stent patency and less stent failure with uncovered stents. QoL is unaffected by stent design. REGISTRATION NUMBER: ISRCTN54834267.