DYSMOSTIM: Lower Esophageal Sphincter (LES) Stimulation in Patients With Ineffective Esophageal Motility
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
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.
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Outcome Measures
Primary Outcome Measures
- Change in patient's GERD-HRQL from baseline to 6 months. [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.
Secondary Outcome Measures
- Change of pH-metry from baseline to 6 months follow up [6 months]
Total % of time of pH < 4 in 24 hours impedance/pH reflux monitoring (ZepHr®, Sandhill Scientific Inc., USA).
- Change of number of reflux events >1minute and >5 minute duration from baseline to 6 months follow up [6 months]
24 hours impedance/pH reflux monitoring (ZepHr®, Sandhill Scientific Inc., USA).
- Distal Contractile Integral [6 months]
High-resolution impedance manometry (InSIGHT Ultima®, Sandhill Scientific Inc., USA)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is indicated for LES Stimulation and plans to undergo antireflux surgery.
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Subject is meeting the criteria of IEM (Chicago classification v3.0)
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Subject provides signed informed consent
Exclusion Criteria:
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Subject is within a vulnerable population or is unable to understand the informed consent.
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Subject is unwilling to attend follow-up visits.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University of Vienna | Vienna | Austria | 1090 |
Sponsors and Collaborators
- Austrian Society Of Surgical Oncology
Investigators
- Study Director: Sebastian F Schoppmann, MD, Medical University of Vienna
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Velanovich V. The development of the GERD-HRQL symptom severity instrument. Dis Esophagus. 2007;20(2):130-4.
- AUT-DYSMOSTIM-01