Endosc Int Open 2016; 04(06): E730-E736
DOI: 10.1055/s-0042-106960
Original article
© Georg Thieme Verlag KG Stuttgart · New York

Antireflux versus conventional self-expanding metallic Stents (SEMS) for distal esophageal cancer: results of a multicenter randomized trial

E. Coron*
1   Institut des Maladies de l’Appareil Digestif, Centre Hospitalier Universitaire, Nantes cedex, France
2   CIC-INSERM, Centre Hospitalier Universitaire, Nantes cedex, France
,
G. David*
1   Institut des Maladies de l’Appareil Digestif, Centre Hospitalier Universitaire, Nantes cedex, France
2   CIC-INSERM, Centre Hospitalier Universitaire, Nantes cedex, France
,
S. Lecleire
3   Service d’Hépatogastroentérologie, Centre Hospitalier Universitaire, Rouen, France
,
J. Jacques
4   Service d’Hépatogastroentérologie, Centre Hospitalier Universitaire, Limoges, France
,
A. Le Sidaner
4   Service d’Hépatogastroentérologie, Centre Hospitalier Universitaire, Limoges, France
,
T. Barrioz
5   Service d’Hépatogastroentérologie, Centre Hospitalier Universitaire, Poitiers, France
,
D. Coumaros
6   Service d’Hépatogastroentérologie, Centre Hospitalier Universitaire, Strasbourg, France
,
C. Volteau
7   Département de Biostatistiques, Centre Hospitalier Universitaire, Nantes, France
,
B. Vedrenne
8   Service d’Hépatogastroentérologie, Centre Hospitalier Universitaire, Mulhouse, France
,
P. Bichard
9   Service d’Hépatogastroentérologie, Centre Hospitalier Universitaire, Grenoble, France
,
C. Boustière
10   Service d’Hépatogastroentérologie, Hopital Saint-Joseph, Marseille, France
,
Y. Touchefeu
1   Institut des Maladies de l’Appareil Digestif, Centre Hospitalier Universitaire, Nantes cedex, France
2   CIC-INSERM, Centre Hospitalier Universitaire, Nantes cedex, France
,
J. Brégeon
2   CIC-INSERM, Centre Hospitalier Universitaire, Nantes cedex, France
,
F. Prat
11   Service d’Hépatogastroentérologie, Hopital Cochin, Paris, France
,
M. Le Rhun
1   Institut des Maladies de l’Appareil Digestif, Centre Hospitalier Universitaire, Nantes cedex, France
2   CIC-INSERM, Centre Hospitalier Universitaire, Nantes cedex, France
,
and the Société Française d’Endoscopie Digestive (SFED) › Institutsangaben
Weitere Informationen

Publikationsverlauf

submitted 23. Oktober 2015

accepted after revision 18. Januar 2016

Publikationsdatum:
21. Juni 2016 (online)

Introduction: Self-expanding metal stents (SEMS) are commonly used in the palliation of dysphagia in patients with inoperable esophageal carcinoma. However, they predispose to gastroesophageal reflux when deployed across the gastroesophageal junction. The aims of this study were to: 1) assess the influence of the antireflux valve on trans-prosthetic reflux (primary outcome); and 2) compare the results of SEMS with and without antireflux valve in terms of reflux symptoms, quality of life (QOL), improvement of dysphagia and adverse events (secondary outcomes).

Patients and methods: Thirty-eight patients were enrolled in nine centers. Carcinomas were locally advanced (47 %) or metastatic. After randomization, patients received either a covered SEMS with antireflux valve (n = 20) or a similar type of SEMS with no antireflux device but assigned to standard proton pump inhibitor therapy and postural advice (n = 18). Trans-prosthetic reflux was assessed at day 2 using a radiological score based on barium esophagography performed after Trendelenburg maneuver and graded from 0 (no reflux) to 12 (maximum). Monthly telephone interviews were conducted for Organisation Mondiale de la Santé (OMS) scoring from 0 (excellent) to 5 (poor), QOL assessment (based on the Reflux-Qual Simplifié scoring system) from 0 (poor) to 100 (excellent), dysphagia scoring from 0 (no dysphagia) to 5 (complete dysphagia) and regurgitation scoring from 0 (no regurgitation) to 16 (maximum).

Results: No difference was noted in terms of age, sex, size of lesion, prosthesis length or need for dilation prior to SEMS placement. No difficulty in placing SEMS nor complications were noted. Radiological scores of reflux were found to be significantly lower in patients with an antireflux stent compared to the conventional stent and associated measures. The regurgitation scores were significantly decreased in patients with antireflux stents during the first 2 months after stent placement and thereafter, they were similar in the two groups. QOL and dysphagia were improved in both groups. Survival rates were comparable in the two groups.

Conclusions: No difference was observed between the two types of SEMS regarding the palliation of dysphagia and improvement of QOL. However, SEMS with an antireflux valve were more effective in preventing trans-prosthetic gastroesophageal reflux but at the cost of an increased likehood of minor adverse events (migrations and/or obstruction of the SEMS).

* These authors contributed equally.


 
  • References

  • 1 Bouvier AM, Binquet C, Gagnaire A et al. Management and prognosis of esophageal cancers: has progress been made?. Eur J cancer 2006; 42: 228-233
  • 2 Siersema PD. New developments in palliative therapy. Best Pract Res Clin Gastroenterol 2006; 20: 959-978
  • 3 Stein HJ, Siewert JR. Improved prognosis of resected esophageal cancer. World J Surg 2004; 28: 520-525
  • 4 Martin RC, Cannon RM, Brown RE et al. Evaluation of quality of life following placement of self-expanding plastic stents as a bridge to surgery in patients receiving neoadjuvant therapy for esophageal cancer. Oncologist 2014; 19: 259-265
  • 5 Wenger U, Luo J, Lundell L et al. A nationwide study of the use of self-expanding stents in patients with esophageal cancer in Sweden. Endoscopy 2005; 37: 329-334
  • 6 Knyrim K, Wagner HJ, Bethge N et al. A controlled trial of an expansive metal stent for palliation of esophageal obstruction due to inoperable cancer. N Engl J Med 1993; 329: 1302-1307
  • 7 Ell C, May A. Self-expanding metal stents for palliation of stenosing tumors of the esophagus and cardia: a critical review. Endoscopy 1997; 29: 392-398
  • 8 Valbuena J. Endoscopic palliative treatment of esophageal and cardial cancer: a new antireflux prosthesis: a study of 40 cases. Cancer 1984; 53: 993-998
  • 9 Dua KS, Kozarek R, Kim J et al. Self-expanding metal esophageal stent with anti-reflux mechanism. Gastrointest Endosc 2001; 53: 603-13
  • 10 Blomberg J, Wenger U, Lagergren J et al. Antireflux stent versus conventional stent in the palliation of distal esophageal cancer. A randomized, multicenter clinical Scand. J Gastroenterol 2010; 45: 208-216
  • 11 Nunes C, Waechter F, Sampaio J et al. Comparative post-operative study of prostheses, with and without an anti-reflux valve system, in the palliative treatment of esophageal carcinoma. Hepatogastroenterology 1999; 46: 2859-2864
  • 12 Shim C, Jung I, Cheon Y 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
  • 13 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
  • 14 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
  • 15 Schoppmeyer K, Golsong J, Schiefke I et al. Antireflux stents for palliation of malignant esophagocardial stenosis. Dis Esophagus 2007; 20: 89-93
  • 16 Sgourakis G, Gockel I, Radtke A et al. The use of self-expanding stents in esophageal and gastroesophageal junction cancer palliation: a meta-analysis and meta-regression analysis of outcomes. Dig Dis Sci 2010; 55: 3018-3030
  • 17 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
  • 18 Sagar PM, Gauperaa T, Sue-Ling H et al. An audit of the treatment of cancer of the oesophagus. Gut 1994; 35: 941-945
  • 19 Walter D, van den Berg M, van Hooft J et al. A new fully covered metal stent with anti-migration. Endoscopy 2014; 46: 1101-1105
  • 20 Mudumbi S, Velazquez-Aviña S, 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
  • 21 Christie NA, Buenaventura PO, Fernando HC et al. Results of expandable metal stents for malignant esophageal obstruction in 100 patients : short term and long term follow up. Ann Thor Surg 2001; 71: 1797-1802
  • 22 Gebski V, Burmeister B, Smithers BM et al. Survival benefits from neoadjuvant chemoradiotherapy or chemotherapy in oesophageal carcinoma: a meta-analysis. Lancet Oncol 2007; 8: 226-234
  • 23 Taieb J, Mitry E, Boige V et al. Optimization of 5-fluorouracil (5-FU)/cisplatin combination chemotherapy with a new schedule of leucovorin, 5-FU and cisplatin (LV5FU2-P regimen) in patients with biliary tract carcinoma. Ann Oncol 2002; 13: 1192-1196
  • 24 Homs M, Steyerberg E, Eijkenboom W et al. Single-dose brachytherapy versus metal stent placement for the palliation of dysphagia from oesophageal cancer: multicentre randomised trial. Lancet 2004; 364: 1497-1504
  • 25 Zhu HD, Guo JH, Mao AW et al. Conventional stents versus stents loaded with (125)iodine seeds for the treatment of unresectable oesophageal cancer: a multicentre, randomised phase 3 trial. Lancet Oncol 2014; 15: 612-619
  • 26 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
  • 27 Touchefeu Y, Archambeaud I, Landi B et al. Chemotherapy versus self-expanding metal stent as primary treatment of severe dysphagia from unresectable oesophageal or gastro-oesophageal junction cancer. Dig Liver Dis 2014; 46: 283-286