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

Austrian Society Of Surgical Oncology

Status: Completed

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

Treatments: Device: Electrical Stimulation of the Lower Esophageal Sphincter

Study type: Interventional

Funder types: Other

Identifiers

NCT03476265

AUT-DYSMOSTIM-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

17 participants in 1 patient group

Ineffective Esophageal Motility and GERD

Experimental group

Description:

Patients with gastroesophageal reflux disease (GERD) refractory to proton pump inhibitors (PPI) and ineffective esophageal motility (IEM) according to the Chicago classification v3.0.

Treatment:

Device: Electrical Stimulation of the Lower Esophageal Sphincter