Gastrointestinal Endoscopy
Volume 75, Issue 1 , Pages 174-178, January 2012

Technical feasibility and safety of a new, implantable reflux control system to prevent gastroesophageal reflux in patients with stents placed through the lower esophageal sphincter (with video)

  • Meike M. Hirdes, MD

      Affiliations

    • Department of Gastroenterology and Hepatology, University Medical Center Utrecht, The Netherlands
    • Corresponding Author InformationReprint requests: M.M.C. Hirdes, MD, Department of Gastroenterology and Hepatology, University Medical Center Utrecht, PO Box 85500, 3508 GA Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands
    • ,
  • Frank P. Vleggaar, MD, PhD

      Affiliations

    • Department of Gastroenterology and Hepatology, University Medical Center Utrecht, The Netherlands
    • ,
  • Hans-Ulrich Laasch, MD, PhD

      Affiliations

    • Department of Radiology, The Christie NHS Foundation Trust, Manchester, United Kingdom
    • ,
  • Peter D. Siersema, MD, PhD, FASGE

      Affiliations

    • Department of Gastroenterology and Hepatology, University Medical Center Utrecht, The Netherlands

Received 1 June 2011; accepted 18 August 2011.

Background

When an esophageal stent is placed through the lower esophageal sphincter (LES), gastroesophageal reflux symptoms may persist despite high-dose proton pump inhibitor therapy. A recently developed, short segment, uncovered nitinol stent with a tricuspid-like valve can be placed inside a previously placed esophageal stent.

Objective

To evaluate the technical feasibility and safety of a reflux control system (RCS) in distally placed esophageal stents.

Design

A prospective case series.

Setting

Two tertiary-care referral centers.

Patients

This study involved 10 patients who had an “open” stent placed through the LES and 1 patient with severe bile reflux after esophagojejunostomy.

Intervention

Placement of an RCS with fluoroscopic and (in selected cases) endoscopic guidance, from April to October 2010.

Main Outcome Measurements

Technical success of RCS placement and complications.

Results

Placement of an RCS was successful on the first attempt in all patients; complete expansion to the wall of the host stent was confirmed by fluoroscopy in all cases. In 3 patients, the host stent migrated in <1 month with the RCS still inside. In 8 patients, the RCS was in place for a median of 134 days (range 33-225 days). Three patients died because of malignant disease progression. Eight RCSs were removed endoscopically, together with the host stent without complications. RCS migration did not occur.

Limitations

Small number of patients, nonrandomized design, lack of pH measurements.

Conclusion

Placement of an RCS in a host stent is technically feasible and safe. An RCS can be considered in symptomatic patients with open esophageal stents to prevent gastroesophageal reflux.

Abbreviations:  GEJ, gastroesophageal junction, ERCS, EndoFLUXX Reflux Control System, LES, lower esophageal sphincter, PPI, proton pump inhibitor, RCS, reflux control system, SEMS, self-expandable metal stent

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 DISCLOSURE: P.D. Siersema serves as an advisor to Boston Scientific Corp, USA and receives research support from Astra Zeneca BV, The Netherlands, and Cook Medical Ltd, Ireland. No other financial relationships relevant to this publication were disclosed.

 If you would like to chat with an author of this article, you may contact Dr Hirdes at M.M.C.Hirdes@umcutrecht.nl

PII: S0016-5107(11)02119-5

doi:10.1016/j.gie.2011.08.037

Gastrointestinal Endoscopy
Volume 75, Issue 1 , Pages 174-178, January 2012

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