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

Quality of Life Clinical Trial

— DYSMOSTIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03476265
• Other study ID #: AUT-DYSMOSTIM-01
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: June 15, 2018

Study information

• Verified date: July 2019
• Source: Austrian Society Of Surgical Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 15, 2018
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysphagia
• Electrical Stimulation of the Lower Esophageal Sphincter
• Esophagitis, Peptic
• Gastro Esophageal Reflux
• Gastroesophageal Reflux
• Quality of Life

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Austrian Society Of Surgical Oncology

Country where clinical trial is conducted

Austria, 

References & Publications (8)

Novitsky YW, Wong J, Kercher KW, Litwin DE, Swanstrom LL, Heniford BT. Severely disordered esophageal peristalsis is not a contraindication to laparoscopic Nissen fundoplication. Surg Endosc. 2007 Jun;21(6):950-4. Epub 2006 Dec 20. — View Citation

Peery AF, Crockett SD, Barritt AS, Dellon ES, Eluri S, Gangarosa LM, Jensen ET, Lund JL, Pasricha S, Runge T, Schmidt M, Shaheen NJ, Sandler RS. Burden of Gastrointestinal, Liver, and Pancreatic Diseases in the United States. Gastroenterology. 2015 Dec;149(7):1731-1741.e3. doi: 10.1053/j.gastro.2015.08.045. Epub 2015 Aug 29. — View Citation

Richter JE. Gastroesophageal reflux disease treatment: side effects and complications of fundoplication. Clin Gastroenterol Hepatol. 2013 May;11(5):465-71; quiz e39. doi: 10.1016/j.cgh.2012.12.006. Epub 2012 Dec 23. Review. — View Citation

Rodríguez L, Rodríguez 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. — View Citation

Rodríguez L, Rodriguez PA, Gómez 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. — View Citation

Subramanian CR, Triadafilopoulos G. Refractory gastroesophageal reflux disease. Gastroenterol Rep (Oxf). 2015 Feb;3(1):41-53. doi: 10.1093/gastro/gou061. Epub 2014 Sep 30. Review. — View Citation

Velanovich V. Comparison of generic (SF-36) vs. disease-specific (GERD-HRQL) quality-of-life scales for gastroesophageal reflux disease. J Gastrointest Surg. 1998 Mar-Apr;2(2):141-5. — View Citation

Velanovich V. The development of the GERD-HRQL symptom severity instrument. Dis Esophagus. 2007;20(2):130-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Distal Contractile Integral	High-resolution impedance manometry (InSIGHT Ultima®, Sandhill Scientific Inc., USA)	6 months