Lower Esophageal Sphincter (LES) Stimulation in Patients With Ineffective Esophageal Motility (DYSMOSTIM)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03476265 |
|
Recruitment Status :
Completed
First Posted : March 26, 2018
Last Update Posted : July 5, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Quality of Life Dysphagia Electrical Stimulation of the Lower Esophageal Sphincter Gastro Esophageal Reflux | Device: Electrical Stimulation of the Lower Esophageal Sphincter | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 17 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | May 1, 2017 |
| Actual Primary Completion Date : | January 15, 2018 |
| Actual Study Completion Date : | June 15, 2018 |
| 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. |
- Change in patient's GERD-HRQL from baseline to 6 months. [ Time Frame: 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.
- Change of pH-metry from baseline to 6 months follow up [ Time Frame: 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 [ Time Frame: 6 months ]24 hours impedance/pH reflux monitoring (ZepHr®, Sandhill Scientific Inc., USA).
- Distal Contractile Integral [ Time Frame: 6 months ]High-resolution impedance manometry (InSIGHT Ultima®, Sandhill Scientific Inc., USA)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03476265
| Austria | |
| Medical University of Vienna | |
| Vienna, Austria, 1090 | |
| Study Director: | Sebastian F Schoppmann, MD | Medical University of Vienna |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Matthias Paireder, Consultant at the Division of Surgery at the Medical University of Vienna, Austrian Society Of Surgical Oncology |
| ClinicalTrials.gov Identifier: | NCT03476265 |
| Other Study ID Numbers: |
AUT-DYSMOSTIM-01 |
| First Posted: | March 26, 2018 Key Record Dates |
| Last Update Posted: | July 5, 2019 |
| Last Verified: | July 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |