Download PDF
Endoscopy 2018; 50(10): 961-971
DOI: 10.1055/a-0620-8135
Original article
© Georg Thieme Verlag KG Stuttgart · New York

Fully vs. partially covered selfexpandable metal stent for palliation of malignant esophageal strictures: a randomized trial (the COPAC study)

Paul Didden
1   Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands
,
Agnes N. Reijm
1   Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands
,
Nicole S. Erler
2   Department of Biostatistics, Erasmus University Medical Center, Rotterdam, The Netherlands
,
Leonieke M. M. Wolters
3   Department of Gastroenterology and Hepatology, Albert Schweitzer Hospital, Dordrecht, The Netherlands
,
Thjon J. Tang
4   Department of Gastroenterology and Hepatology, IJsselland Hospital, Capelle aan den Ijssel, The Netherlands
,
Pieter C. J. ter Borg
5   Department of Gastroenterology and Hepatology, Ikazia Hospital, Rotterdam, The Netherlands
,
Ivonne Leeuwenburgh
6   Department of Gastroenterology and Hepatology, Fransiscus Hospital, Rotterdam, The Netherlands
,
Marco J. Bruno
1   Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands
,
Manon C. W. Spaander
1   Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands
› Author AffiliationsTRIAL REGISTRATION: Interventional study NCT01661686at clinicaltrials.gov
Further Information

Publication History

submitted 23 October 2017

accepted after revision 23 March 2018

Publication Date:
12 June 2018 (online)

Also available at
    Permissions and Reprints

Abstract

Background Covered esophageal self-expandable metal stents (SEMSs) are currently used for palliation of malignant dysphagia. The optimal extent of the covering to prevent recurrent obstruction is unknown. Therefore, we aimed to compare fully covered (FC) versus partially covered (PC) SEMSs in patients with incurable malignant esophageal stenosis.

Methods In this multicenter randomized controlled trial, 98 incurable patients with dysphagia caused by a malignant stricture of the esophagus or cardia were randomized 1:1 to an FC-SEMS or PC-SEMS. The primary outcome was recurrent obstruction after endoscopic SEMS placement. Secondary outcomes were technical and clinical success, adverse events, and health-related quality of life (HRQoL). Patients were followed until 6 months after SEMS placement or to SEMS removal, second SEMS insertion, or death, whichever came first.

Results Recurrent obstruction after SEMS placement was similar for both types of stents: 19 % for FC-SEMSs and 22 % for PC-SEMSs (P = 0.65). The times to recurrent obstruction did not differ. The frequency of adverse events was similar between the two groups, with major adverse events occurring in 38 % and 47 % of patients for FC-SEMSs and PC-SEMSs, respectively (P = 0.34). No significant differences were seen in technical success, improvement of dysphagia, and HRQoL. Proximal esophageal stenosis and female sex were independently associated with recurrent obstruction and/or major adverse events.

Conclusions Esophageal FC-SEMSs did not reveal a lower recurrent obstruction rate compared with PC-SEMSs in the palliative management of malignant dysphagia.

Table e5 and Fig. e6

 

  • References

  • 1 Siersema PD. Treatment options for esophageal strictures. Nat Clin Pract Gastroenterol Hepatol 2008; 5: 142-152
    CrossrefPubMedGoogle Scholar
  • 2 Diamantis G, Scarpa M, Bocus P. et al. Quality of life in patients with esophageal stenting for the palliation of malignant dysphagia. World J Gastroenterol 2011; 17: 144-150
    CrossrefPubMedGoogle Scholar
  • 3 Didden P, Spaander MC, Bruno MJ. et al. Esophageal stents in malignant and benign disorders. Curr Gastroenterol Rep 2013; 15: 319
    CrossrefPubMedGoogle Scholar
  • 4 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
    Article in Thieme ConnectPubMedGoogle Scholar
  • 5 Vakil N, Morris AI, Marcon N. et al. A prospective, randomized, controlled trial of covered expandable metal stents in the palliation of malignant esophageal obstruction at the gastroesophageal junction. Am J Gastroenterol 2001; 96: 1791-1796
    CrossrefPubMedGoogle Scholar
  • 6 Seven G, Irani S, Ross AS. et al. Partially versus fully covered self-expanding metal stents for benign and malignant esophageal conditions: a single center experience. Surg Endosc 2013; 27: 2185-2192
    CrossrefPubMedGoogle Scholar
  • 7 Uitdehaag MJ, van Hooft JE, Verschuur EM. et al. A fully-covered stent (Alimaxx-E) for the palliation of malignant dysphagia: a prospective follow-up study. Gastrointest Endosc 2009; 70: 1082-1089
    CrossrefPubMedGoogle Scholar
  • 8 Uitdehaag MJ, Siersema PD, Spaander MC. et al. A new fully covered stent with antimigration properties for the palliation of malignant dysphagia: a prospective cohort study. Gastrointest Endosc 2010; 71: 600-605
    CrossrefPubMedGoogle Scholar
  • 9 Hirdes MM, Siersema PD, Vleggaar 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
    CrossrefPubMedGoogle Scholar
  • 10 Repici A, Jovani M, Hassan C. et al. Management of inoperable malignant oesophageal strictures with fully covered WallFlex((R)) stent: a multicentre prospective study. Dig Liver Dis 2014; 46: 1093-1098
    CrossrefPubMedGoogle Scholar
  • 11 Wagh MS, Forsmark CE, Chauhan S. et al. Efficacy and safety of a fully covered esophageal stent: a prospective study. Gastrointest Endosc 2012; 75: 678-682
    CrossrefPubMedGoogle Scholar
  • 12 Walter D, van den Berg MW, van Hooft JE. et al. A new fully covered metal stent with anti-migration features for the treatment of malignant dysphagia. Endoscopy 2014; 46: 1101-1105
    Article in Thieme ConnectPubMedGoogle Scholar
  • 13 Rice TW, Blackstone EH, Rusch VW. 7th edition of the AJCC Cancer Staging Manual: esophagus and esophagogastric junction. Ann Surg Oncol 2010; 17: 1721-1724
    CrossrefPubMedGoogle Scholar
  • 14 Sprangers MA, Cull A, Groenvold M. et al. The European Organization for Research and Treatment of Cancer approach to developing questionnaire modules: an update and overview. EORTC Quality of Life Study Group. Qual Life Res 1998; 7: 291-300
    CrossrefPubMedGoogle Scholar
  • 15 Blazeby JM, Conroy T, Hammerlid E. et al. Clinical and psychometric validation of an EORTC questionnaire module, the EORTC QLQ-OES18, to assess quality of life in patients with oesophageal cancer. Eur J Cancer 2003; 39: 1384-1394
    CrossrefPubMedGoogle Scholar
  • 16 Mayoral W, Fleischer D, Salcedo J. et al. Nonmalignant obstruction is a common problem with metal stents in the treatment of esophageal cancer. Gastrointest Endosc 2000; 51: 556-559
    CrossrefPubMedGoogle Scholar
  • 17 Homs MY, Steyerberg EW, Kuipers EJ. et al. Causes and treatment of recurrent dysphagia after self-expanding metal stent placement for palliation of esophageal carcinoma. Endoscopy 2004; 36: 880-886
    Article in Thieme ConnectPubMedGoogle Scholar
  • 18 Hirdes MM, Vleggaar FP, de Beule M. et al. In vitro evaluation of the radial and axial force of self-expanding esophageal stents. Endoscopy 2013; 45: 997-1005
    Article in Thieme ConnectPubMedGoogle Scholar
  • 19 Sabharwal T, Hamady MS, Chui S. et al. A randomised prospective comparison of the Flamingo Wallstent and Ultraflex stent for palliation of dysphagia associated with lower third oesophageal carcinoma. Gut 2003; 52: 922-926
    CrossrefPubMedGoogle Scholar
  • 20 Siersema PD, Hop WC, van Blankenstein M. et al. A comparison of 3 types of covered metal stents for the palliation of patients with dysphagia caused by esophagogastric carcinoma: a prospective, randomized study. Gastrointest Endosc 2001; 54: 145-153
    CrossrefPubMedGoogle Scholar
  • 21 van Heel NC, Haringsma J, Boot H. et al. Comparison of 2 expandable stents for malignant esophageal disease: a randomized controlled trial. Gastrointest Endosc 2012; 76: 52-58
    CrossrefPubMedGoogle Scholar
  • 22 Verschuur EM, Repici A, Kuipers EJ. et al. New design esophageal stents for the palliation of dysphagia from esophageal or gastric cardia cancer: a randomized trial. Am J Gastroenterol 2008; 103: 304-312
    CrossrefPubMedGoogle Scholar
  • 23 White RE, Chepkwony R, Mwachiro M. et al. Randomized trial of small-diameter versus large-diameter esophageal stents for palliation of malignant esophageal obstruction. J Clin Gastroenterol 2015; 49: 660-665
    CrossrefPubMedGoogle Scholar
  • 24 van Boeckel PG, Siersema PD, Sturgess R. et al. A new partially covered metal stent for palliation of malignant dysphagia: a prospective follow-up study. Gastrointest Endosc 2010; 72: 1269-1273
    CrossrefPubMedGoogle Scholar
  • 25 Reijm AN, Didden P, Bruno MJ. et al. Early pain detection and management after esophageal metal stent placement in incurable cancer patients: A prospective observational cohort study. Endosc Int Open 2016; 4: E890-E894
    Article in Thieme ConnectPubMedGoogle Scholar
  • 26 Parker RK, White RE, Topazian M. et al. Stents for proximal esophageal cancer: a case-control study. Gastrointest Endosc 2011; 73: 1098-1105
    CrossrefPubMedGoogle Scholar
  • 27 Verschuur EM, Kuipers EJ, Siersema PD. Esophageal stents for malignant strictures close to the upper esophageal sphincter. Gastrointest Endosc 2007; 66: 1082-1090
    CrossrefPubMedGoogle Scholar
  • 28 Bick BL, Wong Kee Song LM, Buttar NS. et al. Stent-associated esophagorespiratory fistulas: incidence and risk factors. Gastrointest Endosc 2012; 77: 181-189
    PubMedGoogle Scholar
  • 29 Kinsman KJ, DeGregorio BT, Katon RM. et al. Prior radiation and chemotherapy increase the risk of life-threatening complications after insertion of metallic stents for esophagogastric malignancy. Gastrointest Endosc 1996; 43: 196-203
    CrossrefPubMedGoogle Scholar
  • 30 Ross WA, Alkassab F, Lynch PM. et al. Evolving role of self-expanding metal stents in the treatment of malignant dysphagia and fistulas. Gastrointest Endosc 2007; 65: 70-76
    CrossrefPubMedGoogle Scholar
  • 31 Fuccio L, Scagliarini M, Frazzoni L. et al. Development of a prediction model of adverse events after stent placement for esophageal cancer. Gastrointest Endosc 2016; 83: 746-752
    CrossrefPubMedGoogle Scholar
  • 32 Lecleire S, Di Fiore F, Ben-Soussan E. et al. Prior chemoradiotherapy is associated with a higher life-threatening complication rate after palliative insertion of metal stents in patients with oesophageal cancer. Aliment Pharmacol Ther 2006; 23: 1693-1702
    CrossrefPubMedGoogle Scholar
  • 33 Didden P, Spaander MC, Kuipers EJ. et al. Safety of stent placement in recurrent or persistent esophageal cancer after definitive chemoradiotherapy: a case series. Gastrointest Endosc 2012; 76: 426-430
    CrossrefPubMedGoogle Scholar
  • 34 Blazeby JM, Farndon JR, Donovan J. et al. A prospective longitudinal study examining the quality of life of patients with esophageal carcinoma. Cancer 2000; 88: 1781-1787
    CrossrefPubMedGoogle Scholar
  • 35 Homs MY, Essink-Bot ML, Borsboom GJ. et al. Quality of life after palliative treatment for oesophageal carcinoma -- a prospective comparison between stent placement and single dose brachytherapy. Eur J Cancer 2004; 40: 1862-1871
    CrossrefPubMedGoogle Scholar