Anti-reflux versus conventional self-expanding metal stents in the palliation of esophageal cancer: A systematic review and meta-analysis

Abstract

Background and study aims Self-expanding metal stents (SEMS) are an effective palliative endoscopic therapy to reduce dysphagia in esophageal cancer. Gastroesophageal reflux disease (GERD) is a relatively common complaint after non-valved conventional SEMS placement. Therefore, valved self-expanding metal stents (SEMS-V) were designed to reduce the rate of GERD symptoms. We aimed to perform a systematic review and meta-analysis comparing the two stents.

Material and methods This was a systematic review and meta-analysis including only randomized clinical trials (RCT) comparing the outcomes between SEMS-V and non-valved self-expanding metal stents (SEMS-NV) following the Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines. The risk of bias was assessed using the Cochrane Risk of Bias 2 tool. Data were analyzed with Review Manager Software. Quality of evidence was evaluated using Grading of Recommendations Assessment, Development, and Evaluation guidelines.

Results Ten randomized clinical trials including a total of 467 patients, 234 in the SEMS-V group and 233 in the SEMS-NV group, were included. There were no statistically significant differences regarding GERD qualitative analysis (RD –0.17; 95 % CI –0.67, 0.33; P = 0.5) and quantitative analysis (SMD –0.22; 95 % CI –0.53, 0.08; P = 0.15) technical success (RD –0.03; 95 % CI –0.07, 0.01; P = 0.16), dysphagia improvement (RD –0.07; 95 % CI –0.19, 0.06; P = 0.30), and adverse events (RD 0.07; 95 % CI –0.07, 0.20; P = 0.32).

Conclusions Both SEMS-V and SEMS-NV are safe and effective in the palliation of esophageal cancer with similar rates of GERD, dysphagia relief, technical success, adverse events, stent migration, stent obstruction, bleeding, and improvement of the quality of life.

Publication History

Received: 28 March 2022

Accepted after revision: 05 July 2022

Accepted Manuscript online:
07 July 2022

Article published online:
17 October 2022

• References

• 1 SEER Cancer Stat Facts: Esophageal Cancer. National Cancer Institute. https://seer.cancer.gov/statfacts/html/esoph.html
• 2 Global Cancer Observatory: Cancer Today. International Agency for Research on Cancer. https://gco.iarc.fr/today
• 3 Al-Kaabi A, Baranov NS, van der Post RS. et al. Age-specific incidence, treatment, and survival trends in esophageal cancer: a Dutch population-based cohort study. Acta Oncol 2022; 1-8
• 4 Saito E, Yano T, Hori M. et al. Is young-onset esophageal adenocarcinoma increasing in Japan? An analysis of population-based cancer registries. Cancer Med 2022; 11: 1347-1356
• 5 van Rossum PSN, Mohammad NH, Vleggaar FP. et al. Treatment for unresectable or metastatic oesophageal cancer: current evidence and trends. Nat Rev Gastroenterol Hepatol 2018; 15: 235-249
• 6 Elliott JA, Donlon NE, Beddy P. et al. Visceral obesity with and without metabolic syndrome: incidence and clinical impact in esophageal adenocarcinoma treated with curative intent. Dis Esophagus 2022;
• 7 Spaander MCW, van der Bogt RD, Baron TH. et al. Esophageal stenting for benign and malignant disease: European Society of Gastrointestinal Endoscopy (ESGE) Guideline – Update 2021. Endoscopy 2021; 53: 751-762
• 8 Ahmed O, Lee JH, Thompson CC. et al. AGA Clinical Practice Update on the Optimal Management of the Malignant Alimentary Tract Obstruction: Expert Review. Clin Gastroenterol Hepatol 2021; 19: 1780-1788
• 9 Vermeulen BD, Siersema PD. Esophageal stenting in clinical practice: an overview. Curr Treat Options Gastroenterol 2018; 16: 260-273
• 10 Kumar S, Bahdi F, Emelogu IK. et al. How much progress have we made? a 20-year experience regarding esophageal stents for the palliation of malignant dysphagia. Dis Esophagus 2022; 35: doab085
• 11 Reijm A, Didden P, Schelling S. et al. Self-expandable metal stent placement for malignant esophageal strictures – changes in clinical outcomes over time. Endoscopy 2019; 51: 18-29
• 12 Page MJ, McKenzie JE, Bossuyt PM. et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021; 372: n71
• 13 Sterne JAC, Savović J, Page MJ. et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ 2019; 366: l4898
• 14 Hozo SP, Djulbegovic B, Hozo I. Estimating the mean and variance from the median, range, and the size of a sample. BMC Med Res Methodol 2005; 5: 13
• 15 Cumpston M, Li T, Page MJ. et al. Updated guidance for trusted systematic reviews: a new edition of the Cochrane Handbook for Systematic Reviews of Interventions. Cochrane Database Syst Rev 2019; 10: ED000142
• 16 Hout J, Ioannidis JPA, Rovers MM. et al. Plea for routinely presenting prediction intervals in meta-analysis. BMJ Open 2016; 6: e010247
• 17 Dua KS, DeWitt JM, Kessler WR. et al. A phase III, multicenter, prospective, single-blinded, noninferiority, randomized controlled trial on the performance of a novel esophageal stent with an antireflux valve (with video). Gastrointest Endosc 2019; 90: 64-74.e3
• 18 Coron E, David G, Lecleire S. et al. Antireflux versus conventional self-expanding metallic Stents (SEMS) for distal esophageal cancer: results of a multicenter randomized trial. Endosc Int Open 2016; 4: E730-E736
• 19 Blomberg J, Wenger U, Lagergren J. et al. Antireflux stent versus conventional stent in the palliation of distal esophageal cancer. A randomized, multicenter clinical trial. Scand J Gastroenterol 2010; 45: 208-216
• 20 Sabharwal T, Gulati MS, Fotiadis N. et al. Randomised comparison of the FerX Ella antireflux stent and the ultraflex stent: Proton pump inhibitor combination for prevention of post-stent reflux in patients with esophageal carcinoma involving the esophago-gastric junction. J Gastroenterol Hepatol 2008; 23: 723-728
• 21 Power C, Byrne PJ, Lim K. et al. Superiority of anti-reflux stent compared with conventional stents in the palliative management of patients with cancer of the lower esophagus and esophago-gastric junction: results of a randomized clinical trial. Dis Esophagus 2007; 20: 466-470
• 22 Wenger U, Johnsson E, Arnelo U. et al. An antireflux stent versus conventional stents for palliation of distal esophageal or cardia cancer: a randomized clinical study. Surg Endosc 2006; 20: 1675-1680
• 23 Shim CS, Jung IS, Cheon YK. et al. Management of malignant stricture of the esophagogastric junction with a newly designed self-expanding metal stent with an antireflux mechanism. Endoscopy 2005; 37: 335-339
• 24 Homs MY V, Wahab PJ, Kuipers EJ. et al. Esophageal stents with antireflux valve for tumors of the distal esophagus and gastric cardia: a randomized trial. Gastrointest Endosc 2004; 60: 695-702
• 25 Laasch H-U, Marriott A, Wilbraham L. et al. Effectiveness of open versus antireflux stents for palliation of distal esophageal carcinoma and prevention of symptomatic gastroesophageal reflux. Radiology 2002; 225: 359-365
• 26 Kaduthodil MJ, Lowe AS, Thrower A. et al. A randomised controlled study on the effectiveness of ‘antireflux’ stent versus ‘standard open’ for inoperable tumours of gastro oesophageal junction and in the prevention of symptomatic gastro-oesophageal reflux. Cardiovasc Intervent Radiol 2011; 34: 492
• 27 Hourneaux G, de Moura E, Sakai P. et al. Palliative treatment of advanced esophageal cancer. Comparative study: auto-expandable metal stent and isoperistaltic esophagogastric bypass. Acta Gastroenterol Latinoam 2001; 31: 13-22
• 28 Spaander M, Baron T, Siersema P. et al. Esophageal stenting for benign and malignant disease: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy 2016; 48: 939-948
• 29 Pandit S, Samant H, Morris J. et al. Efficacy and safety of standard and anti-reflux self-expanding metal stent: A Systematic review and meta-analysis of randomized controlled trials. World J Gastrointest Endosc 2019; 11: 271-280
• 30 Osugi H, Lee S, Higashino M. et al. Usefulness of self-expandable metallic stent with an antireflux mechanism as a palliation for malignant strictures at the gastroesophageal junction. Surg Endosc 2002; 16: 1478-1482
• 31 Schoppmeyer K, Golsong J, Schiefke I. et al. Antireflux stents for palliation of malignant esophagocardial stenosis. Dis Esophagus 2007; 20: 89-93
• 32 Yang Z-M, Geng H-T, Wu H. Radioactive stent for malignant Esophageal Obstruction: A Meta-Analysis of Randomized Controlled Trials. J Laparoendosc Adv Surg Tech 2021; 31: 783-789
• 33 Zhao C-L, Gu B, Huo X-B. et al. I-125 seed-loaded versus normal stent insertion for obstructive esophageal cancer: a meta-analysis. Videosurgery Other Miniinvasive Tech 2021; 16: 633-640
• 34 Mudumbi S, Velazquez-Aviña J, Neumann H. et al. Anchoring of self-expanding metal stents using the over-the-scope clip, and a technique for subsequent removal. Endoscopy 2014; 46: 1106-1109
• 35 Law R, Prabhu A, Fujii-Lau L. et al. S. Stent migration following endoscopic suture fixation of esophageal self-expandable metal stents: a systematic review and meta-analysis. Surg Endosc 2018; 32: 675-681
• 36 Saranovic D, Djuric-Stefanovic A, Ivanovic A. et al. Fluoroscopically guided insertion of self-expandable metal esophageal stents for palliative treatment of patients with malignant stenosis of esophagus and cardia: comparison of uncovered and covered stent types. Dis Esophagus 2005; 18: 230-238
• 37 Yakoub D, Fahmy R, Athanasiou T. et al. Evidence-based choice of esophageal stent for the palliative management of malignant dysphagia. World J Surg 2008; 32: 1996-2009
• 38 Şentürk M, Çakır M, Yıldırım MA. et al. Stent applications for palliative treatment in advanced stage esophageal cancers. Gastroenterol Res Pract 2021;
• 39 Turner D, Ricciuto A, Lewis A. et al. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology 2021; 160: 1570-1583
• 40 Blazeby JM, Williams MH, Brookes ST. et al. Quality of life measurement in patients with oesophageal cncer. Gut 1990; 37: 505-508