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).

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.