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

NCT ID: NCT03476265

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2018-06-15

Brief Summary

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

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ineffective Esophageal Motility and GERD

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

Group Type: EXPERIMENTAL

Electrical Stimulation of the Lower Esophageal Sphincter

Intervention Type: DEVICE

Laparoscopic implantation of an electrical stimulation device to perform an electrical sphincter augmentation for the treatment of GERD.

Interventions

Electrical Stimulation of the Lower Esophageal Sphincter

Laparoscopic implantation of an electrical stimulation device to perform an electrical sphincter augmentation for the treatment of GERD.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Austrian Society Of Surgical Oncology

OTHER

Sponsor Role: lead

Responsible Party

Matthias Paireder

Consultant at the Division of Surgery at the Medical University of Vienna

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sebastian F Schoppmann, MD

Role: STUDY_DIRECTOR

Medical University of Vienna

Locations

Medical University of Vienna

Vienna, , Austria

Countries

Austria

References

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Reference Type: BACKGROUND

PMID: 26327134 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 25274499 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 23267868 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 17177077 (View on PubMed)

Rodriguez L, Rodriguez P, Neto MG, Ayala JC, Saba J, Berel D, Conklin J, Soffer E. Short-term electrical stimulation of the lower esophageal sphincter increases sphincter pressure in patients with gastroesophageal reflux disease. Neurogastroenterol Motil. 2012 May;24(5):446-50, e213. doi: 10.1111/j.1365-2982.2012.01878.x. Epub 2012 Jan 31.

Reference Type: BACKGROUND

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Rodriguez L, Rodriguez PA, Gomez B, Netto MG, Crowell MD, Soffer E. Electrical stimulation therapy of the lower esophageal sphincter is successful in treating GERD: long-term 3-year results. Surg Endosc. 2016 Jul;30(7):2666-72. doi: 10.1007/s00464-015-4539-5. Epub 2015 Oct 20.

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Paireder M, Kristo I, Asari R, Jomrich G, Steindl J, Rieder E, Schoppmann SF. Effect of electrical stimulation therapy of the lower esophageal sphincter in GERD patients with ineffective esophageal motility. Surg Endosc. 2021 Nov;35(11):6101-6107. doi: 10.1007/s00464-020-08104-3. Epub 2020 Oct 30.

Reference Type: DERIVED

PMID: 33128080 (View on PubMed)

Other Identifiers

AUT-DYSMOSTIM-01

Identifier Type: -

Identifier Source: org_study_id