Lower Esophageal Sphincter (LES) Stimulation in Patients With Ineffective Esophageal Motility

Study Overview
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Brief Summary
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The aim of this study is to evaluate gastroesophageal reflux disease - health related quality of life (GERD-HRQL) after electrical stimulation of the lower esophageal sphincter (LES) in patients with gastroesophageal reflux disease (GERD) and esophageal dysmotility.

Detailed Description
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Background The growing burden of gastroesophageal reflux disease (GERD) still impacts healthcare costs intensively. Although the treatment with proton pump inhibitor (PPI) is effective in many cases, surgical treatment remains relevant due to a large amount of PPI refractory GERD. Laparoscopic fundoplication (LF) is considered as standard procedure, but this type of surgery is linked to side effects as dysphagia, gas bloating and inability to belch. Especially patients with ineffective esophageal motility (IEM) are prone to postoperative dysphagia after LF. Lower esophageal sphincter electrical stimulation (LES-EST) was introduced as an alternative technique to avoid side effects of LF. Rodriquez et al. have bee demonstrated that LES-EST significantly raises the LES pressure and improved GERD symptoms such as heartburn and regurgitation. The advantage of this procedure is that the anatomy of the esophageal-gastric junction is not altered dramatically. Notably, patients with severely disordered esophageal peristalsis will benefit from this low-risk profile. After successful implementation of this technique at the Medical University of Vienna (EK 1149/2014), a prospective evaluation of data with the well established gastroesophageal reflux disease - health-related quality of life is next. Patients with esophageal motility disorder, who undergo LES-EST, will be investigated towards side effects such as gas-bloating, inability to belch, flatulence and dysphagia.

Official Title
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Evaluation of Gastroesophageal Reflux Disease - Health Related Quality of Life After Lower Esophageal Sphincter (LES) Stimulation in Patients With Ineffective Esophageal Motilitygus (IEM)

Conditions
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Quality of Life, Dysphagia, Electrical Stimulation of the Lower Esophageal Sphincter, Gastro Esophageal Reflux

Intervention / Treatment
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* Device: Electrical Stimulation of the Lower Esophageal Sphincter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is indicated for LES Stimulation and plans to undergo antireflux surgery. Subject is meeting the criteria of IEM (Chicago classification v3.0) Subject provides signed informed consent Exclusion Criteria: Subject is within a vulnerable population or is unable to understand the informed consent. Subject is unwilling to attend follow-up visits.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ineffective Esophageal Motility and GERD<br>Patients with gastroesophageal reflux disease (GERD) refractory to proton pump inhibitors (PPI) and ineffective esophageal motility (IEM) according to the Chicago classification v3.0. | Device: Electrical Stimulation of the Lower Esophageal Sphincter<br>* Laparoscopic implantation of an electrical stimulation device to perform an electrical sphincter augmentation for the treatment of GERD.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient's GERD-HRQL from baseline to 6 months. | GERD related quality of life (QoL) is assessed with the gastroesophageal reflux disease - health related quality of life (GERD-HRQL) questionnaire. QoL is measured at baseline and at six months afters surgery. At unscheduled follow up visits QoL assessment is non-compulsory. The GERD-HRQL score consists of ten questions regarding GERD-related symptoms and their influence on QoL. Total scores range from 0 to 75. Testing will be split to a questionnaire for heartburn (0-30) and a questionnaire for regurgitation (0-30), the two cardinal symptoms of GERD. Lower scores indicate better QoL. This questionnaire was designed to objectively quantify symptom severity and was described validated by Velanovich et al and since then is the most frequently used GERD specific questionnaire. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of pH-metry from baseline to 6 months follow up | Total % of time of pH < 4 in 24 hours impedance/pH reflux monitoring (ZepHr®, Sandhill Scientific Inc., USA). | 6 months | 
| Change of number of reflux events >1minute and >5 minute duration from baseline to 6 months follow up | 24 hours impedance/pH reflux monitoring (ZepHr®, Sandhill Scientific Inc., USA). | 6 months | 
| Distal Contractile Integral | High-resolution impedance manometry (InSIGHT Ultima®, Sandhill Scientific Inc., USA) | 6 months |