Treatment of refractory post-esophagectomy anastomotic esophageal strictures using temporary fully covered esophageal metal stenting compared to repeated bougie dilation: results of a randomized controlled trial

Abstract

Background and study aims Fully covered self-expanding metal stents (FCSEMS) provide an alternative to bougie dilation (BD) for refractory benign esophageal strictures. Controlled studies comparing temporary placement of FCSES to repeated BD are not available.

Patients and methods Patients with refractory anastomotic esophageal strictures, dysphagia scores ≥ 2, and two to five prior BD were randomized to 8 weeks of FCSEMS or to repeated BD. The primary endpoint was the number of BD during the 12 months after baseline treatment.

Results Eighteen patients were included (male 67 %, median age 66.5; 9 received metal stents, 9 received BD). Technical success rate of stent placement and stent removal was 100 %. Recurrent dysphagia occurred in 13 patients (72 %) during follow-up. No significant difference was found between the stent and BD groups for mean number of BD during follow-up (5.4 vs. 2.4, P = 0.159), time to recurrent dysphagia (median 36 days vs. 33 days, Kaplan-Meier: P = 0.576) and frequency of reinterventions per month (median 0.3 vs. 0.2, P = 0.283). Improvement in quality of life score was greater in the stent group compared to the BD group at month 12 (median 26 % vs. 4 %, P = 0.011).

Conclusions The current data did not provide evidence for a statistically significant difference between the two groups in the number of BD during the 12 months after initial treatment. Metal stenting offers greater improvement in quality of life from baseline at 12 months compared to repeated BD for patients with refractory anastomotic esophageal strictures.

• References

• 1 Eloubeidi MA, Lopes TL. Novel removable internally fully covered self-expandable metal esophageal stent: feasibility, technique of removal and tissue response in humans. Am J Gastroenterol 2009; 104: 1374-1381
• 2 van Boeckel PG, Siersema PD. Refractory strictures: what to do when dilation fails. Curr Treat Option Gastroenterol 2015; 13: 47-58
• 3 Conio M, Blanchi S, Filiberti R. et al. Self-expanding stents in benign esophageal strictures. Tech Gastrointest Endosc 2008; 10: 164-174
• 4 Repici A, Hassan C, Sharma P. et al. Systemic review: the role of self-expanding plastic stents for benign oesophageal strictures. Aliment Pharmacol Ther 2010; 31: 1268-1275
• 5 Grooteman KV, Wong Kee Song LM, Vleggaar FP. et al. Non-adherence to the rule of 3 does not increase the risk of adverse events in esophageal dilation. Gastrointest Endosc 2017; 85: 332-337
• 6 Sigounas DE, Siddhi S, Plevris JN. Biodegradable esophageal stents in benign and malignant strictures – a single center experience. Endosc Int Open 2016; 4: E618-E623
• 7 Brinster CJ, Singhal S, Lee L. et al. Evolving options in the management of esophageal perforation. Ann Thorac Surg 2004; 77: 1475-1483
• 8 Fry LC, Monkemuller K, Neumann H. et al. Incidence, clinical management and outcomes of esophageal perforations after endoscopic dilatation. Z Gastroenterol 2007; 45: 1180-1184
• 9 Lew RJ, Kochman ML. A review of endoscopic methods of esophageal dilation. J Clin Gastroenterol 2002; 35: 117-126
• 10 Ferguson DD. Evaluation and management if benign esophageal strictures. Dis Esophagus 2005; 18: 359-364
• 11 Bakken JC, Song WK, de Groen PC. et al. Use of a fully covered self-expandable metal stent for the treatment of benign esophageal diseases. Gastrointest Endosc 2010; 72: 712-720
• 12 Lee JG, Hsu R, Leung JW. Are self-expanding metal mesh stents useful in the treatment of benign esophageal stenoses and fistulas? An experience of four cases. Am J Gastroenterol 2000; 95: 1920-1925
• 13 Hirdes MM, van Hooft JE, Wijrdeman HK. et al. Combination of biodegradable stent placement and single-dose brachytherapy is associated with an unacceptably high complication rate in the treatment of dysphagia from esophageal cancer. Gastrointest Endosc 2012; 76: 267-274
• 14 van Halsema EE, Wong Kee Song LM, Baron TH. et al. Safety of endoscopic removal of self-expandable stents after treatment of benign esophageal diseases. Gastrointest Endosc 2013; 77: 18-28
• 15 Spaander MC, Baron TH, Siersema PD. et al. Esophageal stenting for benign and malignant disease: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy 2016; 48: 939-948
• 16 Schembre D. Advances in esophageal stenting: the evolution of fully covered stents for malignant and benign disease. Adv Ther 2010; 27: 413-425
• 17 van Boeckel PG, Vleggaar FP, Siersema PD. Biodegradable stent placement in the esophagus. Expert Rev Med Devices 2013; 10: 37-43
• 18 Eloubedi MA, Talreja JP, Lopes TL. et al. Success and complications associated with placement of fully covered removable self-expandable metal stents for benign esophageal diseases (with videos). Gastrointest Endosc 2011; 73: 673-681
• 19 Liu J, Hu Y, Cui C. et al. Removable, fully covered, self-expandable metal stents for the treatment of refractory benign esophagogastric anastomotic strictures. Dysphagia 2012; 27: 260-264
• 20 Speer E, Dunst CM, Shada A. et al. Covered stents in cervical anastomoses following esophagectomy. Surg Endosc 2016; 30: 3297-3303
• 21 Repici A, Small AJ, Mendelson A. et al. Natural history and management of refractory benign esophageal strictures. Gastrointest Endosc 2016; 84: 222-228
• 22 Ogilvie AL, Dronfield MW, Ferguson R. et al. Palliative intubation of oesophagogastric neoplasms at fibreoptic endoscopy. Gut 1982; 23: 1060-1067
• 23 Hirdes MMC, Siersema PD, Vleggar FP. A new fully covered metal stent for the treatment of benign and malignant dysphagia: a prospective follow-up study. Gastrointest Endosc 2012; 75: 712-718
• 24 The EuroQol Group. EuroQol-a new facility for the measurement of health-related quality of life. Health Policy 1990; 16: 199-208