Downloaded from http://journals.lww.com/annalsofsurgery by BhDMf5ePHKbH4TTImqenVHVWbIH6TTJXBvkFNlHfPHP2iaMCAUwo+hIG7eRLp5Gu on 10/17/2020 Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved. Long-term Oncologic Results After Stenting as a Bridge to Surgery Versus Emergency Surgery for Malignant Left-sided Colonic Obstruction A Multicenter Randomized Controlled Trial (ESCO Trial) Alberto Arezzo,  Edoardo Forcignano `,  Marco Augusto Bonino,  Carmen Balague ´, y Eduardo Targarona, y Felice Borghi, z Giorgio Giraudo, z Luigi Ghezzo, z Roberto Passera, § and Mario Morino  Y, on behalf of the collaborative ESCO study group Objective: To assess overall (OS), time to progression (TTP), and disease- free survival (DFS) at 3 years after treatment, comparing stenting as bridge-to- surgery (SBTS) versus emergency surgery (ES) in neoplastic left colon obstruction, secondary endpoints of the previously published randomized controlled trial. Background: While SBTS in neoplastic colon obstruction may reduce morbidity and need for a stoma compared with ES, concern has been raised, about long-term survival. Methods: Individuals affected by left-sided malignant large-bowel obstruc- tion were enrolled from 5 European hospitals and randomly assigned (1:1 ratio) to receive SBTS or ES. The computer-generated randomization sequence was stratified by center on cT and concealed by the use of a web-based application. Investigators and participants were unmasked to treatment assignment. The secondary outcomes analyzed here were OS, TTP, and DFS. Analysis was by intention to treat. This study is registered, ID-code NCT00591695. Results: Between March 2008 and November 2015, 144 patients were randomly assigned to undergo either SBTS or ES; 115 (SBTS n ¼ 56, ES n ¼ 59) were eligible for analysis, while 20 participants were excluded for a benign disease, 1 for unavailability of the endoscopist while 8 withdrew from the trial. With a median follow-up of 37 months (range 1–62), no difference was observed in the SBTS group compared with ES in terms of OS (HR 0.93 (95% CI 0.49–1.76), P ¼ 0.822), TTP (HR 0.81 (95% CI 0.42–1.54), P ¼ 0.512), and DFS (HR 1.01 (95% CI 0.56–1.81), P ¼ 0.972). Planned subgroup analysis showed no difference in respect to age, sex, American Society for Anesthesiology score, body mass index, and pT between SBTS and ES groups. Those participants randomized for the SBTS group whose obstruction was located in the descending colon had a better TTP compared with ES group (HR 0.44 (95% CI 0.20–0.97), P ¼ 0.042), but no difference was observed in terms of OS (HR 0.73 (95% CI 0.33–1.63), P ¼ 0.442) and DFS (HR 0.68 (95% CI 0.34–1.34), P ¼ 0.261) in the same individuals. Conclusions: This randomized controlled trial shows that, although not powered for these seconday outcomes, OS, TTP, and DFS did not differ between groups at a minimum follow-up of 36 months. Keywords: bridge to surgery, emergency colorectal surgery, endoscopic stenting, large bowel obstruction, randomized controlled trial (Ann Surg 2020;272:703–708) W hile stenting with palliative intent for metastatic colorectal cancer is commonly accepted, the optimal treatment with curative intent of symptomatic left-sided tumor obstruction of the large bowel is still controversial. Two years after the completion of the ESCO study 1 and the presentation of short-term results, we presented a systematic review and meta-analysis 2 of randomized controlled trials (RCTs), according to which Stent Bridge to Surgery (SBTS) was associated with a reduced overall morbidity and a reduction in temporary stoma rates compared with emergency surgery (ES). Nevertheless, whether the treatment of choice should be a stent followed by surgical resections it depends not only on the short- term, but most importantly on long-term results. Are short-term benefits of SBTS sufficient to consider this technique as a new standard for the treatment of patients with obstructive colorectal carcinoma? To answer this question we should first answer the question whether stenting influences the incidence of tumor recur- rence. In this regard, it should be noted that 1 randomized trial showed an increased rate of tumor recurrence. 3 This result suggests that stenting can adversely affect cancer survivals in patients affected by a curable tumor, as stated by ESGE guidelines. 4 These contradictory data form the basis of the ongoing discussion on the long-term safety of colon stents used as SBTS. We need evidence from prospective, preferably randomized, trials to confirm or deny the long-term safety of the stent placement. There- fore, we present here the 3-year follow-up results of the ESCO study. METHODS The European Association for Endoscopic Surgery endorsed this multicenter RCT. The Local Ethics Committee of the Citta ` della Salute e della Scienza di Torino approved the project. The University of Torino, Italy, served as coordinator. The project was registered at ClinicalTrials.gov, US International Clinical Trials Databank (US From the  Department of Surgical Sciences, University of Torino, Torino, Italy; ySurgical Department, Hospital de la Santa Creu i Sant Pau, Universitat Auto ` noma de Barcelona, Barcelona, Spain; zASO Santa Croce e Carle, Cuneo, Italy; and §Department of Medical sciences, University of Torino, Torino, Italy. mario.morino@unito.it. The study was endorsed by the European Association for Endoscopic Surgery in 2008. The Collaborative ESCO study group includes Antonio Arroyo, MD, Javier Sola- Vera, MD: Hospital General Universitario, Elche, Italy. The Collaborative ESCO study group includes Paolo De Paolis, MD, Maurizio Bossotti, MD: General Surgery 3, San Giovanni Nuovo Hospital, Torino, Italy. The Collaborative ESCO study group includes Elisa Bannone, MD: Department of General and Pancreatic Surgery – The Pancreas Institute, University of Verona Hospital Trust, Verona, Italy. The authors report no conflicts of interest. Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s Web site (www.annalsofsurgery.com). Copyright ß 2020 Wolters Kluwer Health, Inc. All rights reserved. ISSN: 0003-4932/20/27205-0703 DOI: 10.1097/SLA.0000000000004324 Annals of Surgery  Volume 272, Number 5, November 2020 www.annalsofsurgery.com | 703 ESA-RANDOMIZED CONTROLLED TRIAL